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A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies (MDX1106-01)

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ClinicalTrials.gov Identifier: NCT00441337
Recruitment Status : Completed
First Posted : February 28, 2007
Results First Posted : February 20, 2015
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Non-Small-Cell Lung
Colorectal Cancer
Malignant Melanoma
Renal Cancer
Prostate Cancer
Intervention Biological: MDX-1106
Enrollment 39
Recruitment Details Study from 25 October 2006 to 27 November 2009. After completion of a single dose (cycle 1), those meeting criteria could be re-treated with 2 additional doses (cycle 2); and additional cycles. Participants who had a complete response (CR) or partial response (PR) at end of re-treatment were followed-up until disease progression for 2 years.
Pre-assignment Details 39 participants were enrolled and 39 were treated with at least 1 dose or a partial dose of study drug.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description 0.3 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
Period Title: Overall Study
Started 6 6 6 21
Completed 0 0 0 0
Not Completed 6 6 6 21
Reason Not Completed
Disease Progression             6             6             4             18
Lost to Follow-up             0             0             0             1
Sponsor Decision             0             0             1             2
Did not meet inclusion criteria             0             0             1             0
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab Total
Hide Arm/Group Description 0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 21 39
Hide Baseline Analysis Population Description
All participants who received at least 1 dose or any partial dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 21 participants 39 participants
56.5  (5.7) 68.3  (9.4) 61.0  (10.4) 63.2  (10.0) 62.6  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 21 participants 39 participants
Female
2
  33.3%
3
  50.0%
2
  33.3%
10
  47.6%
17
  43.6%
Male
4
  66.7%
3
  50.0%
4
  66.7%
11
  52.4%
22
  56.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 21 participants 39 participants
White 4 3 4 18 29
Black 2 3 2 3 10
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 21 participants 39 participants
6 6 6 21 39
Body Weight in kilograms (kg)  
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 6 participants 6 participants 6 participants 21 participants 39 participants
96.8
(88 to 136)
73.9
(62 to 80)
81.9
(55 to 98)
81.3
(56 to 118)
81.3
(55 to 136)
Time since initial diagnosis (years)  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 21 participants 39 participants
3.7
(1.4 to 6.8)
2.7
(1.5 to 14.0)
5.6
(0.7 to 11.4)
4.1
(1.0 to 19.8)
3.8
(0.7 to 19.8)
Type of Malignancy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 21 participants 39 participants
Prostate Cancer 0 1 2 5 8
Melanoma 0 2 0 8 10
Non-small cell lung cancer 1 1 2 2 6
Renal cell cancer 0 0 0 1 1
Colorectal cancer 5 2 2 5 14
Stage of Malignancy at Screening Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 21 participants 39 participants
Stage I 0 0 0 0 0
Stage II 0 0 0 0 0
Stage III 1 0 0 0 1
Stage IV 5 6 6 21 38
[1]
Measure Description: The investigator reported the screening malignancy stage for each type of cancer using the American Joint Committee on Cancer Classification (Stages I, II, III, and IV).
1.Primary Outcome
Title Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug.
Time Frame Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 6 21
Measure Type: Number
Unit of Measure: participants
Severe AE 5 5 4 18
SAE 3 5 4 9
SAE through 28 days post study discontinuation 3 5 4 11
Drug-Related AE 5 5 6 19
Death 1 4 1 6
Discontinuation of Study Drug due to AE 0 0 0 2
irAE 1 3 2 9
Dose-Limiting Toxicity AE 0 0 0 0
2.Primary Outcome
Title Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose
Hide Description Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).
Time Frame Day 1 to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 5 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
6.7
(21.6%)
16.0
(32.1%)
60.0
(27.6%)
196.3
(19.5%)
3.Primary Outcome
Title Median Time at Which the Maximum Serum Concentration Occurred (Tmax) Post-Single Dose
Hide Description Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Tmax was measured in hours (h).
Time Frame Day 1 to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 5 21
Median (Full Range)
Unit of Measure: h
3.0
(1.0 to 6.8)
1.9
(1.0 to 7.0)
3.1
(1.0 to 5.0)
1.6
(0.9 to 7.0)
4.Primary Outcome
Title Geometric Mean Area Under the Curve (AUC) From Time of Dosing to Time of Last Observation (0-T) and Extrapolated to Infinity (INF) Observed Post-Single Dose
Hide Description AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation. AUC(INF): Area under the curve from the time of dosing extrapolated to infinity. Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms*hours per milliliter (µg*h/mL).
Time Frame Day 1 to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 5 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*h/mL
AUC (0-T); n=6, 6, 5, 21
970
(47%)
3244
(62%)
13909
(44%)
55324
(39%)
AUC (INF); n=3, 4, 5, 19
2343
(16%)
6014
(30%)
15813
(44%)
76541
(27%)
5.Primary Outcome
Title Mean Elimination Half-life (T-HALF) Post-Single Dose
Hide Description Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of T-HALF was measured in days.
Time Frame Day 1 to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 3 4 5 19
Mean (Standard Deviation)
Unit of Measure: days
18.9  (7.05) 17.0  (2.36) 17.0  (4.70) 24.8  (7.22)
6.Primary Outcome
Title Geometric Mean Total Body Clearance of Drug From Serum (CLT) Post-Single Dose
Hide Description Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of CLT was measured in milliliters per hour per kilogram body weight (mL/h/kg).
Time Frame Day 1 to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 3 4 5 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/h/kg
0.13
(16.93%)
0.17
(29.80%)
0.19
(42.66%)
0.13
(28.42%)
7.Primary Outcome
Title Mean Volume of Distribution (Vz) Post-Single Dose
Hide Description Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Vz was measured in milliliters per kilogram of body weight (mL/kg).
Time Frame Day 1 to Day 85
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Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 3 4 5 19
Mean (Standard Deviation)
Unit of Measure: mL/kg
82.8  (27.19) 99.6  (23.04) 112.7  (39.50) 109.4  (26.70)
8.Primary Outcome
Title Percent of Participants With Best Overall Response Rate in Safety Population and in Tumor Evaluable Population
Hide Description The Best Overall Response Rate (BORR) was defined as the number of participants who had a confirmed complete response (CR) or partial response (PR) during the study divided by the total number of participants evaluated. Response was based on tumor assessment for both target and non-target lesions using: Clinical examination; Chest X-ray; Computed Tomography and Magnetic Resonance Imaging; Bone scan; Ultrasound. Per National Cancer Institute Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, best overall response (BOR) for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. Confidence intervals (CIs) were computed using the Clopper and Pearson method.
Time Frame Day 1 up to 2 Years.
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Hide Analysis Population Description
Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. Tumor Evaluable Population: all participants who received complete dose(s) of nivolumab and had completed a major tumor assessment (a baseline and at least 1 post-baseline tumor assessment for either target and/or non-target assessments.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 6 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Safety Population (n=6,6,6,21)
0
(0.0 to 45.9)
0
(0.0 to 45.9)
16.7
(0.4 to 64.1)
9.5
(1.2 to 30.4)
Tumor Evaluable Population (n=6,5,6,20)
0
(0.0 to 45.9)
0
(0.0 to 52.2)
16.7
(0.4 to 64.1)
10.0
(1.2 to 31.7)
9.Primary Outcome
Title Percent of Participants With Prostate-Specific Antigen (PSA) Response After the First Dose by Day 85 In Participants With Hormone-Refractory Prostate Adenocarcinoma (HRPC)
Hide Description The PSA response rate was defined as the number of participants who had at least a 50% decrease of the PSA value from the PSA reference value divided by the total number of participants evaluated (percent of participants). PSA reference value was the PSA concentration measured immediately prior to dosing on Day 1. PSA response was assessed using the Recommendations from the National Cancer Institute Prostate-Specific Antigen Working Group. A PSA response had to be confirmed at least 4 weeks after first response. 95% exact CIs were computed using the Clopper and Pearson method.
Time Frame Day 1 to Day 85
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Hide Analysis Population Description
The PSA evaluable population was analyzed and included all HRPC participants who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least one post baseline PSA assessment. A PSA evaluable participant could not have any major inclusion/exclusion violation, dosing violation, or protocol conduct violation.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 0 1 2 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 97.5)
0
(0.0 to 84.2)
0
(0.0 to 52.2)
10.Secondary Outcome
Title Number of Participants With Best Overall Response (BOR) by Category in Safety Population
Hide Description Measurable and non-measurable disease/target lesions were evaluated according to National Cancer Institute standardized RECIST.Complete Response (CR)=disappearance of all target and non-target lesions and no new lesions; Partial Response=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; Stable disease (SD)=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since treatment; PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. BOR was recorded between the first tumor assessment and last tumor assessment. CR and PR had to be confirmed by repeat assessment no less than 4 weeks after the criteria were first met. SD assessment must have met the criteria at least once at or after Week 12.
Time Frame Day 1 to Day 85
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Hide Analysis Population Description
Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 6 21
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0 0 0
Partial Response 0 0 1 2
Stable Disease 1 1 2 6
Progressive Disease 5 4 3 12
Unknown 0 0 0 1
Missing 0 1 0 0
11.Secondary Outcome
Title Percentage of Participants With Disease Control and Major Durable Disease Control
Hide Description Disease control rate was defined as number of participants whose Best Overall Response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) divided by the total number of participants. Major durable disease control rate was defined as the total number of participants whose BOR was CR, PR, or SD ≥24 weeks, divided by the total number of participants. Per RECIST v 1.0, BOR for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter since treatment; SD=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD. PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. 95% CIs were computed using the Clopper and Pearson method.
Time Frame Day 1 to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population was analyzed: All participants who received at least 1 dose or any partial dose of nivolumab.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 6 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Disease Control Rate
16.7
(0.4 to 64.1)
16.7
(0.4 to 64.1)
50.0
(11.8 to 88.2)
38.1
(18.1 to 61.6)
Major Durable Disease Control Rate ≥24 weeks
0
(0.0 to 45.9)
16.7
(0.4 to 64.1)
33.3
(4.3 to 77.7)
4.8
(0.1 to 23.8)
12.Secondary Outcome
Title Median Time to Tumor Response and Duration of Tumor Response
Hide Description Time to tumor response: from the date of first dose to the first date of tumor response (CR or PR confirmed at least 4 weeks later); for nonresponders, it was censored at the date of the maximum tumor assessment time in the dose cohort by the end of study. Duration of tumor response was calculated from the first date of response of CR or PR to the date of the first PD or the date of death if a participant died due to disease progression (whichever occurred first). Duration of response was censored at the last tumor assessment date by the end of study if a responder did not have PD or death. Nonresponders had the duration of response as an event of 0 days.
Time Frame Day 1 to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and were tumor responders were analyze.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 0 0 1 2
Median (95% Confidence Interval)
Unit of Measure: days
Time to Tumor Response
57 [1] 
(NA to NA)
386
(85 to 687)
Duration of Tumor Response
796 [1] 
(NA to NA)
327
(92 to 562)
[1]
insufficient number of participants to calculate CI
13.Secondary Outcome
Title Time to Tumor Progression and Tumor Progression Free Survival
Hide Description Time to tumor progression (TTP) was measured in days from date of the first dose to the date of the first PD or the date of death if due to PD. For those who died without PD it was censored at the date of death. TTP was censored at the last tumor assessment by the end of study if a participant did not have PD or death. Tumor progression free survival (PFS) was measured in days from the date of first dose to the date of the first disease progression or to the date of death. PFS was censored at the last tumor assessment date by the end of study if a participant did not have PD or death.
Time Frame Day 1 to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 6 21
Median (95% Confidence Interval)
Unit of Measure: days
Time to Tumor Progression
56
(51 to 57)
57.5
(57 to 59)
86
(57 to 193)
57
(53 to 85)
Tumor Progression Free Survival
56
(51 to 57)
57.5
(57 to 59)
86
(57 to 193)
57
(53 to 85)
14.Secondary Outcome
Title Median Time to PSA Progression in Days and Median PSA Progression Free Survival in Days in PSA Evaluable Population
Hide Description Time to PSA progression: first dose to first PSA progression. Missing date of progression was censored: if death during the study, time to progression was right-censored at last PSA assessment; if no progression from first dose and still alive at end of study, time to progression was right-censored at last PSA assessment by end of study; if no PSA progression and one has discontinued from the study (other than death or PSA progression), time to progression was right-censored at last PSA assessment. PSA progression free survival (PFS): first dose to first PSA progression or death, whichever comes first. Missing date of progression was censored: if one did not have PSA progression from first dose and was still alive at end of study, PSA PFS was right-censored at last PSA assessment; if one does not have any progression and discontinued from the study for reasons other than death or progression, PFS was right-censored at last assessment. CI computed using Brookmeyer and Crowley method.
Time Frame Day 1 to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The PSA evaluable population include all participants in the study who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least 1 post-baseline PSA assessment.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 0 1 2 5
Median (95% Confidence Interval)
Unit of Measure: days
Time to PSA Progression
29 [1] 
(NA to NA)
58.5
(29 to 88)
29
(22 to 57)
PSA Progression Free Survival
29 [1] 
(NA to NA)
58.5
(29 to 88)
29
(22 to 57)
[1]
insufficient number of participants to calculate CI
15.Secondary Outcome
Title Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population
Hide Description PSA relative velocity (PSA RV) was defined as = (d[PSA]/dt)/ [PSA], where [PSA] =concentration of PSA, and t= time, and in the limit reflects the instantaneous change in PSA levels as a fraction of total PSA level. Decreases in PSA RV may occur while measured [PSA] is still rising, and may indicate that continued therapy may lead to a treatment benefit, particularly in the setting of immunotherapy, where expansion of an effective immune response is likely to require weeks to mature. Baseline PSA RV was based on the velocity of last PSA measurement before the first infusion of study drug and the screening PSA measurement.
Time Frame Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PSA evaluable population includes all participants in the study who received complete dose(s) of nivolumab and has a baseline PSA assessment and at least 1 post-baseline PSA assessment.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 0 1 2 5
Median (Full Range)
Unit of Measure: percentage of total PSA level
Cycle 1 Day 29 (n=0, 1, 2, 5)
0.009
(0.009 to 0.009)
-0.007
(-0.017 to 0.003)
-0.015
(-0.040 to 0.002)
Cycle 1 Day 57 (n=0, 1, 2, 5)
0.003
(0.003 to 0.003)
-0.009
(-0.010 to -0.008)
0.001
(-0.036 to 0.018)
Cycle 1 Day 85 (n=0, 1, 2, 4)
0.007
(0.007 to 0.007)
0.001
(-0.003 to 0.004)
-0.005
(-0.044 to 0.017)
16.Secondary Outcome
Title Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population
Hide Description 12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle). In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. PR, QRS and QT interval were measured in milliseconds (msec).
Time Frame Baseline, Day 2, Day 85, Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had available ECG at baseline and on the specified post treatment study day were analyzed.
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 6 21
Mean (Standard Deviation)
Unit of Measure: msec
PR at Day 2 (n=6,6,6,21) 7.3  (6.15) -9.7  (10.31) -1.7  (9.75) -0.3  (13.72)
QRS at Day 2 (n=6,6,6,21) 5.0  (6.90) -2.0  (7.48) -8.7  (19.83) -1.2  (5.57)
QT at Day 2 (n=6,6,6,21) 2.0  (27.86) -15.7  (22.89) -2.0  (15.90) -10.1  (20.76)
PR at Day 57 (n=0,0,0,3) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) -11.3  (24.11)
QRS at Day 57 (n=0,0,0,3) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 1.3  (5.03)
QT at Day 57 (n=0,0,0,3) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 5.3  (33.61)
PR at Day 85 (n=0,4,4,11) NA [1]   (NA) -4.5  (11.82) 3.5  (17.69) -1.1  (17.44)
QRS at Day 85 (n=0,4,4,11) NA [1]   (NA) -6.0  (9.09) -4.0  (6.73) 0.2  (4.24)
QT at Day 85 (n=0,4,4,11) NA [1]   (NA) -6.0  (27.90) -3.5  (33.52) -0.2  (26.40)
PR at Day 113 (n=0,0,2,3) NA [1]   (NA) NA [1]   (NA) 11.0  (24.04) 3.3  (4.62)
QRS at Day 113 (n=0,0,2,3) NA [1]   (NA) NA [1]   (NA) 4.0  (2.83) 6.0  (6.93)
QT at Day 113 (n=0,0,2,3) NA [1]   (NA) NA [1]   (NA) 4.0  (50.91) 6.0  (28.00)
[1]
no participants with data on this day in this arm
17.Secondary Outcome
Title Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population
Hide Description Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Post infusion DBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below.
Time Frame Baseline, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.
Arm/Group Title 0.3 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (n=6) 80.3  (18.16)
Infusion (0 minutes) (n=5) 82.4  (10.01)
21 minutes post infusion (n=6) 87.0  (10.28)
36 minutes post infusion (n=6) 81.0  (10.88)
51 minutes post infusion (n=6) 79.8  (9.20)
66 minutes post infusion (n=6) 80.3  (8.71)
82 minutes post infusion (n=6) 81.7  (8.69)
97 minutes post infusion (n=6) 80.3  (10.56)
112 minutes post infusion (n=6) 78.7  (8.14)
127 minutes post infusion (n=6) 81.0  (11.14)
157 minutes post infusion (n=2) 72.5  (6.36)
1 hour post infusion (n=6) 80.5  (8.96)
2 hour post infusion (n=6) 82.2  (11.02)
3 hour post infusion (n=6) 74.5  (6.35)
4 hour post infusion (n=6) 73.8  (6.08)
6 hour post infusion (n=6) 78.2  (10.44)
8 hour post infusion (n=6) 76.2  (5.67)
18.Secondary Outcome
Title Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population
Hide Description Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBP on Day 1 for first dose (cycle 1) are presented below.
Time Frame Baseline, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.
Arm/Group Title 0.3 mg/kg Nivolumab
Hide Arm/Group Description:
0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (n=6) 141.8  (15.03)
Infusion (0 minutes) (n=5) 144.2  (17.05)
21 minutes post infusion (n=6) 154.3  (22.90)
36 minutes post infusion (n=6) 140.3  (14.71)
51 minutes post infusion (n=6) 147.5  (10.05)
66 minutes post infusion (n=6) 141.0  (15.44)
82 minutes post infusion (n=6) 145.7  (17.60)
97 minutes post infusion (n=6) 141.8  (16.29)
112 minutes post infusion (n=6) 139.8  (11.55)
127 minutes post infusion (n=6) 140.3  (20.47)
157 minutes post infusion (n=2) 137.5  (7.78)
1 hour post infusion (n=6) 139.3  (8.04)
2 hour post infusion (n=6) 145.8  (20.85)
3 hour post infusion (n=6) 140.3  (7.92)
4 hour post infusion (n=6) 139.8  (9.89)
6 hour post infusion (n=6) 142.8  (19.06)
8 hour post infusion (n=6) 145.5  (12.77)
19.Secondary Outcome
Title Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population
Hide Description Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion DBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below.
Time Frame Baseline, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.
Arm/Group Title 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 21
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (n=6, 6, 21) 80.3  (11.62) 72.2  (10.72) 74.4  (12.19)
Infusion (0 minutes) (n=6, 5, 19) 79.2  (11.72) 73.6  (10.01) 74.2  (11.31)
15 minutes post infusion (n=6,6,21) 74.5  (11.41) 69.5  (10.41) 72.3  (11.87)
30 minutes post infusion (n=6,6,21) 78.8  (11.0) 70.7  (10.29) 71.1  (10.40)
45 minutes post infusion (n=6,6,21) 75.7  (10.67) 69.8  (12.09) 72.7  (12.69)
60 minutes post infusion (n=6,6,21) 78.7  (8.78) 69.5  (9.97) 74.1  (10.53)
75 minutes post infusion (n=5,3,12) 79.0  (11.20) 71.7  (0.58) 73.7  (11.93)
90 minutes post infusion (n=4,4,14) 79.8  (8.73) 70.3  (8.18) 74.4  (11.09)
1 hour post infusion (n= 6,5,21) 78.5  (7.58) 74.4  (17.18) 71.9  (10.24)
2 hour post infusion (n= 6,6,21) 83.0  (10.35) 70.7  (19.04) 72.0  (10.62)
3 hour post infusion (n= 6,5,19) 79.5  (13.20) 67.8  (24.59) 72.9  (11.98)
4 hour post infusion (n= 6,6,21) 75.2  (17.68) 69.2  (13.64) 73.5  (9.86)
6 hour post infusion (n= 6,6,21) 74.7  (7.81) 77.7  (13.35) 73.1  (10.32)
8 hour post infusion (n= 5,5,21) 83.8  (8.04) 76.4  (15.29) 74.7  (8.33)
20.Secondary Outcome
Title Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in in 1mg, 3mg, and 10 mg Cohorts - Safety Population
Hide Description Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBPs on Day 1 for first dose (cycle 1) are presented below.
Time Frame Baseline, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.
Arm/Group Title 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description:
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
Overall Number of Participants Analyzed 6 6 21
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (n=6, 6, 21) 133.2  (2.86) 121.3  (13.11) 128.8  (19.29)
Infusion (0 minutes) (n=6, 5, 19) 138.8  (10.65) 116.4  (8.56) 129.5  (17.38)
15 minutes post infusion (n=6,6,21) 136.7  (12.03) 117.3  (8.64) 125.5  (16.54)
30 minutes post infusion (n=6,6,21) 139.2  (6.71) 119.8  (10.82) 124.0  (14.00)
45 minutes post infusion (n=6,6,21) 141.2  (12.19) 111.5  (5.79) 123.5  (14.38)
60 minutes post infusion (n=6,6,21) 142.3  (3.78) 115.0  (5.69) 124.8  (14.39)
75 minutes post infusion (n=5,3,12) 134.0  (8.69) 119.3  (10.21) 126.2  (18.01)
90 minutes post infusion (n=4,4,14) 134.0  (7.62) 119.0  (8.76) 126.1  (14.24)
1 hour post infusion (n= 6,5,21) 141.2  (5.74) 120.6  (15.69) 121.2  (16.72)
2 hour post infusion (n= 6,6,21) 131.3  (9.91) 119.7  (11.04) 123.4  (14.76)
3 hour post infusion (n= 6,5,19) 133.5  (9.79) 122.2  (12.24) 125.4  (15.29)
4 hour post infusion (n= 6,6,21) 133.0  (9.94) 128.5  (19.61) 125.9  (13.20)
6 hour post infusion (n= 6,6,21) 137.0  (11.63) 130.0  (14.21) 124.6  (15.77)
8 hour post infusion (n= 5,5,21) 144.8  (13.81) 130.6  (19.36) 130.6  (12.21)
Time Frame Day 1 through long-term follow-up until either progressive disease or 2 years elapsed.
Adverse Event Reporting Description Study was initiated in 2006 and completed in 2009
 
Arm/Group Title 0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Hide Arm/Group Description 0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
All-Cause Mortality
0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   5/6 (83.33%)   4/6 (66.67%)   11/21 (52.38%) 
Blood and lymphatic system disorders         
Anaemia  1  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  0/21 (0.00%) 
Gastrointestinal disorders         
Abdominal pain upper  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Ileus  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Ascites  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Colitis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Small intestinal obstruction  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Gastritis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Gastrointestinal haemorrhage  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Intestinal obstruction  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Rectal haemorrhage  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Abdominal pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
General disorders         
Pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Hepatobiliary disorders         
Acute hepatic failure  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Infections and infestations         
Pneumonia  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Sepsis  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Injury, poisoning and procedural complications         
Fracture  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Investigations         
Alanine aminotransferase increased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Metabolism and nutrition disorders         
Anorexia  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Dehydration  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Hyperkalaemia  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Hyperglycaemia  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Flank pain  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Osteoarthritis  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Metastatic pain  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Malignant neoplasm progression  1  1/6 (16.67%)  4/6 (66.67%)  1/6 (16.67%)  4/21 (19.05%) 
Metastases to central nervous system  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Metastases to spine  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Nervous system disorders         
Central nervous system lesion  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Myoclonus  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Brain oedema  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Dizziness  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Spinal cord compression  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Aphasia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Psychiatric disorders         
Confusional state  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Mood altered  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Anxiety  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Renal and urinary disorders         
Renal failure  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Ureteric obstruction  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Bladder obstruction  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Nephrolithiasis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Reproductive system and breast disorders         
Pelvic pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Respiratory failure  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Pulmonary embolism  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Dyspnoea  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Pleural effusion  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0.3 mg/kg Nivolumab 1 mg/kg Nivolumab 3 mg/kg Nivolumab 10 mg/kg Nivolumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   21/21 (100.00%) 
Blood and lymphatic system disorders         
Leukopenia  1  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  2/21 (9.52%) 
Hypergammaglobulinaemia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Neutropenia  1  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  2/21 (9.52%) 
Anaemia  1  1/6 (16.67%)  4/6 (66.67%)  3/6 (50.00%)  12/21 (57.14%) 
Hypochromasia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/21 (9.52%) 
Microcytosis  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Thrombocytopenia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Leukocytosis  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Lymphopenia  1  4/6 (66.67%)  1/6 (16.67%)  3/6 (50.00%)  9/21 (42.86%) 
Cardiac disorders         
Tachycardia  1  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  3/21 (14.29%) 
Atrial fibrillation  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Palpitations  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Ear and labyrinth disorders         
Eustachian tube dysfunction  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Eye disorders         
Eye pain  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/21 (0.00%) 
Vision blurred  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/21 (0.00%) 
Gastrointestinal disorders         
Abdominal pain lower  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/21 (9.52%) 
Flatulence  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Vomiting  1  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  9/21 (42.86%) 
Abdominal pain upper  1  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  4/21 (19.05%) 
Diarrhoea haemorrhagic  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Dry mouth  1  1/6 (16.67%)  1/6 (16.67%)  2/6 (33.33%)  7/21 (33.33%) 
Dysphagia  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Frequent bowel movements  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Abdominal distension  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  3/21 (14.29%) 
Pruritus ani  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Gingival pain  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Mouth ulceration  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Stomatitis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Dyspepsia  1  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  6/21 (28.57%) 
Melaena  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Ascites  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Cheilitis  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Colitis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Nausea  1  0/6 (0.00%)  3/6 (50.00%)  4/6 (66.67%)  11/21 (52.38%) 
Diarrhoea  1  0/6 (0.00%)  3/6 (50.00%)  1/6 (16.67%)  4/21 (19.05%) 
Gastritis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Haemorrhoids  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Rectal haemorrhage  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Abdominal pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Constipation  1  0/6 (0.00%)  1/6 (16.67%)  3/6 (50.00%)  10/21 (47.62%) 
General disorders         
Non-cardiac chest pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Chills  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  4/21 (19.05%) 
Influenza like illness  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/21 (9.52%) 
Catheter site erythema  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Injection site reaction  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/21 (19.05%) 
Chest pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Infusion site oedema  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Oedema  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Oedema peripheral  1  2/6 (33.33%)  3/6 (50.00%)  2/6 (33.33%)  3/21 (14.29%) 
Pyrexia  1  1/6 (16.67%)  2/6 (33.33%)  2/6 (33.33%)  4/21 (19.05%) 
Asthenia  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Fatigue  1  2/6 (33.33%)  5/6 (83.33%)  4/6 (66.67%)  12/21 (57.14%) 
Gait disturbance  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/21 (9.52%) 
Hepatobiliary disorders         
Hepatomegaly  1  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Hyperbilirubinaemia  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Liver disorder  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Jaundice  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Immune system disorders         
Hypersensitivity  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Infections and infestations         
Infection  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Oral candidiasis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Urinary tract infection  1  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  4/21 (19.05%) 
Bacteriuria  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  5/21 (23.81%) 
Candidiasis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Herpes zoster  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Rash pustular  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Folliculitis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Furuncle  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Sinusitis  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Upper respiratory tract infection  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Hordeolum  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Bronchitis  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/21 (0.00%) 
Rhinitis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Injury, poisoning and procedural complications         
Back injury  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Procedural pain  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Wound secretion  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Arthropod bite  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Contusion  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Muscle strain  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Sunburn  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Investigations         
Blood chloride decreased  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/21 (4.76%) 
Blood thyroid stimulating hormone increased  1  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  4/21 (19.05%) 
Carbon dioxide decreased  1  0/6 (0.00%)  4/6 (66.67%)  4/6 (66.67%)  6/21 (28.57%) 
Crystal urine present  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/21 (4.76%) 
Electrocardiogram ST-T change  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Electrocardiogram abnormal  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Glucose urine  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/21 (4.76%) 
Weight decreased  1  5/6 (83.33%)  2/6 (33.33%)  3/6 (50.00%)  9/21 (42.86%) 
Blood uric acid decreased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
CD4 lymphocytes decreased  1  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  14/21 (66.67%) 
Crystal urine  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Eosinophil count increased  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  4/21 (19.05%) 
T-lymphocyte count decreased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/21 (19.05%) 
B-lymphocyte count increased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Bacteria urine  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Blood creatinine increased  1  0/6 (0.00%)  2/6 (33.33%)  2/6 (33.33%)  1/21 (4.76%) 
Blood phosphorus increased  1  0/6 (0.00%)  1/6 (16.67%)  3/6 (50.00%)  3/21 (14.29%) 
Blood potassium decreased  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Blood urine present  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Eosinophil count decreased  1  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  4/21 (19.05%) 
Haematocrit decreased  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  2/21 (9.52%) 
Haemoglobin decreased  1  2/6 (33.33%)  4/6 (66.67%)  1/6 (16.67%)  4/21 (19.05%) 
Mean cell volume decreased  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Monocyte count increased  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Rheumatoid factor  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Rheumatoid factor positive  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
White blood cell count increased  1  2/6 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  3/21 (14.29%) 
White blood cells urine  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Blood bicarbonate decreased  1  1/6 (16.67%)  4/6 (66.67%)  3/6 (50.00%)  5/21 (23.81%) 
Blood bilirubin increased  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/21 (4.76%) 
Blood lactate dehydrogenase increased  1  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  4/21 (19.05%) 
Blood magnesium decreased  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
C-reactive protein increased  1  1/6 (16.67%)  4/6 (66.67%)  4/6 (66.67%)  8/21 (38.10%) 
Protein total decreased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Thyroxine decreased  1  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/21 (0.00%) 
Urine colour abnormal  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Weight increased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Alanine aminotransferase increased  1  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  3/21 (14.29%) 
B-lymphocyte count decreased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  4/21 (19.05%) 
Blood sodium decreased  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  5/21 (23.81%) 
Blood urea decreased  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
CD8 lymphocytes decreased  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Carbon dioxide increased  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Lipase increased  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Monocyte count decreased  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  7/21 (33.33%) 
Neutrophil count increased  1  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  5/21 (23.81%) 
Urinary sediment present  1  1/6 (16.67%)  3/6 (50.00%)  1/6 (16.67%)  7/21 (33.33%) 
Aspartate aminotransferase increased  1  3/6 (50.00%)  2/6 (33.33%)  0/6 (0.00%)  6/21 (28.57%) 
Blood alkaline phosphatase increased  1  2/6 (33.33%)  2/6 (33.33%)  3/6 (50.00%)  13/21 (61.90%) 
Breath sounds abnormal  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
CD4 lymphocytes increased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Mean cell haemoglobin concentration decreased  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  4/21 (19.05%) 
Red blood cell count decreased  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Red blood cells urine  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Rheumatoid factor increased  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/21 (4.76%) 
Specific gravity urine increased  1  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  4/21 (19.05%) 
White blood cells urine positive  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Blood albumin decreased  1  0/6 (0.00%)  3/6 (50.00%)  1/6 (16.67%)  4/21 (19.05%) 
Blood calcium decreased  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  3/21 (14.29%) 
Blood chloride increased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  3/21 (14.29%) 
Blood creatine phosphokinase increased  1  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/21 (0.00%) 
Blood glucose increased  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  7/21 (33.33%) 
Blood urea increased  1  1/6 (16.67%)  3/6 (50.00%)  0/6 (0.00%)  3/21 (14.29%) 
Blood uric acid increased  1  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  3/21 (14.29%) 
Mean cell haemoglobin decreased  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  4/21 (19.05%) 
Platelet count increased  1  3/6 (50.00%)  1/6 (16.67%)  1/6 (16.67%)  6/21 (28.57%) 
Troponin increased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Antinuclear antibody positive  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/21 (0.00%) 
Blood phosphorus decreased  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  2/21 (9.52%) 
Blood potassium increased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Blood thyroid stimulating hormone decreased  1  0/6 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  5/21 (23.81%) 
Interleukin level increased  1  0/6 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  0/21 (0.00%) 
Lymphocyte count decreased  1  0/6 (0.00%)  3/6 (50.00%)  1/6 (16.67%)  6/21 (28.57%) 
Thyroxine free increased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/21 (4.76%) 
White blood cell count decreased  1  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  4/21 (19.05%) 
Metabolism and nutrition disorders         
Anorexia  1  2/6 (33.33%)  3/6 (50.00%)  1/6 (16.67%)  3/21 (14.29%) 
Hypocalcaemia  1  1/6 (16.67%)  4/6 (66.67%)  3/6 (50.00%)  8/21 (38.10%) 
Type 2 diabetes mellitus  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Hyperphosphataemia  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/21 (4.76%) 
Decreased appetite  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Hypercalcaemia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Hypoalbuminaemia  1  3/6 (50.00%)  0/6 (0.00%)  1/6 (16.67%)  2/21 (9.52%) 
Hypokalaemia  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  2/21 (9.52%) 
Hyponatraemia  1  4/6 (66.67%)  3/6 (50.00%)  2/6 (33.33%)  5/21 (23.81%) 
Dehydration  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  3/21 (14.29%) 
Hyperkalaemia  1  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/21 (4.76%) 
Hypophosphataemia  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Hypermagnesaemia  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Hyperglycaemia  1  3/6 (50.00%)  2/6 (33.33%)  2/6 (33.33%)  4/21 (19.05%) 
Hypoglycaemia  1  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  3/21 (14.29%) 
Hyperuricaemia  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/6 (0.00%)  1/6 (16.67%)  3/6 (50.00%)  9/21 (42.86%) 
Muscle spasms  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Musculoskeletal chest pain  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/21 (9.52%) 
Pain in jaw  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/21 (4.76%) 
Groin pain  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Myalgia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  4/21 (19.05%) 
Arthralgia  1  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  4/21 (19.05%) 
Musculoskeletal pain  1  0/6 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  3/21 (14.29%) 
Flank pain  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Joint stiffness  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/21 (9.52%) 
Arthritis  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Pain in extremity  1  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  2/21 (9.52%) 
Bone pain  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/21 (0.00%) 
Muscle atrophy  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/21 (0.00%) 
Muscular weakness  1  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Metastatic pain  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  2/21 (9.52%) 
Tumour pain  1  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  2/21 (9.52%) 
Nervous system disorders         
Hypoaesthesia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/21 (19.05%) 
Sinus headache  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Tremor  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/21 (4.76%) 
Ataxia  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/21 (4.76%) 
Dizziness  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  5/21 (23.81%) 
Headache  1  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  7/21 (33.33%) 
Apraxia  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Lethargy  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Dysgeusia  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Peripheral sensory neuropathy  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/21 (0.00%) 
Psychiatric disorders         
Confusional state  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Depression  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Insomnia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  4/21 (19.05%) 
Anxiety  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Renal and urinary disorders         
Dysuria  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Nocturia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Urinary incontinence  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/21 (4.76%) 
Urinary retention  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Haematuria  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Proteinuria  1  2/6 (33.33%)  3/6 (50.00%)  2/6 (33.33%)  8/21 (38.10%) 
Reproductive system and breast disorders         
Scrotal swelling  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Dysphonia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  4/21 (19.05%) 
Nasal congestion  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/21 (9.52%) 
Productive cough  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Sinus disorder  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Cough  1  0/6 (0.00%)  2/6 (33.33%)  2/6 (33.33%)  5/21 (23.81%) 
Dyspnoea exertional  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  5/21 (23.81%) 
Haemoptysis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/21 (4.76%) 
Dyspnoea  1  0/6 (0.00%)  2/6 (33.33%)  3/6 (50.00%)  5/21 (23.81%) 
Pharyngolaryngeal pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Pleural effusion  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/21 (4.76%) 
Pulmonary fibrosis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Postnasal drip  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  3/21 (14.29%) 
Rhinorrhoea  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Skin and subcutaneous tissue disorders         
Dermatitis  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Hyperhidrosis  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Erythema  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  5/21 (23.81%) 
Night sweats  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  4/21 (19.05%) 
Pruritus  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  4/21 (19.05%) 
Skin lesion  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/21 (0.00%) 
Rash erythematous  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Rash pruritic  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/21 (4.76%) 
Rash  1  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  7/21 (33.33%) 
Skin exfoliation  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Ecchymosis  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/21 (0.00%) 
Dry skin  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  3/21 (14.29%) 
Facial wasting  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Alopecia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/21 (4.76%) 
Hypoaesthesia facial  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/21 (0.00%) 
Vascular disorders         
Hypotension  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/21 (14.29%) 
Hypertension  1  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  0/21 (0.00%) 
Hot flush  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/21 (9.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00441337     History of Changes
Other Study ID Numbers: CA209-001 ST
MDX1106-01 ( Other Identifier: BMS )
First Submitted: February 27, 2007
First Posted: February 28, 2007
Results First Submitted: January 21, 2015
Results First Posted: February 20, 2015
Last Update Posted: February 20, 2015