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A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02179918
Recruitment Status : Completed
First Posted : July 2, 2014
Results First Posted : October 11, 2018
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Solid Tumors
Interventions Drug: PF-05082566
Drug: MK-3475
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg every 3 weeks (q3wks) on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Period Title: Overall Study
Started 5 3 3 3 9
Completed 1 0 1 0 1
Not Completed 4 3 2 3 8
Reason Not Completed
Death             0             0             0             1             0
Lost to Follow-up             0             0             1             0             0
Progressive Disease             4             1             1             2             6
Other             0             1             0             0             1
Subject refused further follow-up             0             1             0             0             1
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. Total of all reporting groups
Overall Number of Baseline Participants 5 3 3 3 9 23
Hide Baseline Analysis Population Description
Baseline analysis population included all participants who were assigned to study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 3 participants 3 participants 3 participants 9 participants 23 participants
60.0  (15.4) 62.0  (11.4) 51.7  (22) 54.7  (21) 58.8  (19.4) 58.0  (16.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 3 participants 9 participants 23 participants
Female
1
  20.0%
0
   0.0%
2
  66.7%
2
  66.7%
4
  44.4%
9
  39.1%
Male
4
  80.0%
3
 100.0%
1
  33.3%
1
  33.3%
5
  55.6%
14
  60.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 3 participants 9 participants 23 participants
White 4 3 0 3 5 15
Black 0 0 0 0 1 1
Asian 1 0 1 0 1 3
Other 0 0 2 0 2 4
1.Primary Outcome
Title Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475
Hide Description Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) <1000/mm3 with a single temperature of >38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade>=3 neutropenic infection; Grade>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade>=3 toxicities (non-laboratory); Grade>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period.
Time Frame First 2 cycles of treatment up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The DLT evaluable set was a subset of the safety analysis set and included all participants who were eligible, received both study treatments and who either experienced a DLT during the first 2 cycles of PF-05082566 or completed the 2 cycles' DLT observation period.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0
2.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities)
Hide Description An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by National Cancer Institute (NCI) CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.
Time Frame Baseline up to 90 days after the last dose of study drug, approximately 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
SAE 2 0 1 2 5 10
AE 5 3 3 3 9 23
Grade 1 0 1 2 1 0 4
Grade 2 2 1 0 0 2 5
Grade 3 2 1 1 1 7 12
Grade 4 0 0 0 1 0 1
Grade 5 1 0 0 0 0 1
3.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related)
Hide Description An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.
Time Frame Baseline up to 90 days after the last dose of study drug, approximately 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
SAE 0 0 0 0 0 0
AE 4 3 3 2 6 18
Grade 1 1 3 2 1 1 8
Grade 2 3 0 1 0 4 8
Grade 3 0 0 0 1 1 2
Grade 4 0 0 0 0 0 0
Grade 5 0 0 0 0 0 0
4.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related)
Hide Description An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.
Time Frame Baseline up to 90 days after the last dose of study drug, approximately 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
SAE 1 0 0 0 0 18
AE 4 3 3 2 6 1
Grade1 1 3 2 1 1 8
Grade 2 3 0 1 0 4 8
Grade 3 0 0 0 1 1 2
Grade 4 0 0 0 0 0 0
Grade 5 0 0 0 0 0 0
5.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related)
Hide Description An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.
Time Frame Baseline up to 90 days after the last dose of study drug, approximately 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
SAE 0 0 0 0 0 0
AE 4 3 3 2 6 18
Grade 1 1 3 2 1 1 8
Grade 2 3 0 1 0 4 8
Grade 3 0 0 0 1 1 2
Grade 4 0 0 0 0 0 0
Grade 5 0 0 0 0 0 0
6.Secondary Outcome
Title Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology)
Hide Description The hematology laboratory test included: absolute neutrophil count, hemoglobin, platelet count, white blood cell with differential, coagulation panel, urinalysis and pregnancy test. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with hematology laboratory test was assessed.
Time Frame Baseline up to 28 days after the last dose of study drug, approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
Anemia Grade 0-1 3 2 2 1 6 14
Anemia Grade 2 2 1 0 1 2 6
Anemia Grade 3-4 0 0 1 1 1 3
Hemoglobin Increased Grade 0-1 5 3 3 3 9 23
Hemoglobin Increased Grade 2 0 0 0 0 0 0
Hemoglobin Increased Grade 3-4 0 0 0 0 0 0
Lymphocyte Count Increased Grade 0-1 5 3 3 3 9 23
Lymphocyte Count Increased Grade 2 0 0 0 0 0 0
Lymphocyte Count Increased Grade 3-4 0 0 0 0 0 0
Lymphopenia Grade 0-1 1 2 1 1 2 7
Lymphopenia Grade 2 2 0 2 0 5 9
Lymphopenia Grade 3-4 2 1 0 2 2 7
Neutrophils (Absolute) Grade 0-1 5 3 3 3 9 23
Neutrophils (Absolute) Grade 2 0 0 0 0 0 0
Neutrophils (Absolute) Grade 3-4 0 0 0 0 0 0
Platelets Grade 0-1 5 3 3 3 8 22
Platelets Grade 2 0 0 0 0 1 1
Platelets Grade 3-4 0 0 0 0 0 0
White Blood Cells Grade 0-1 4 3 2 3 7 19
White Blood Cells Grade 2 1 0 1 0 2 4
White Blood Cells Grade 3-4 0 0 0 0 0 0
7.Secondary Outcome
Title Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries)
Hide Description The chemical laboratory test included: sodium, potassium, total calcium, creatinine, albumin, alanine aminotransferase, alanine aminotransferase, glucose, phosphorus, magnesium, total bilirubin, blood urea nitrogen, alkaline phosphatase, lactate dehydrogenase, immunoglobulin G, total protein, uric acid, thyroid function assessments, hepatitis B and C tests. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with chemistry laboratory test was assessed.
Time Frame Baseline up to 28 days after the last dose of study drug, approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
Alanine Aminotransferase (ALT) Grade 0-1 5 3 3 3 8 22
ALT Grade 2 0 0 0 0 1 1
ALT Grade 3-4 0 0 0 0 0 0
Alkaline Phosphatase Grade 0-1 4 3 3 1 9 20
Alkaline Phosphatase Grade 2 1 0 0 1 0 2
Alkaline Phosphatase Grade 3-4 0 0 0 1 0 1
Aspartate Aminotransferase (AST) Grade 0-1 4 3 3 3 8 21
AST Grade 2 1 0 0 0 1 2
AST Grade 3-4 0 0 0 0 0 0
Bilirubin (Total) Grade 0-1 5 2 3 3 8 21
Bilirubin (Total) Grade 2 0 1 0 0 0 1
Bilirubin (Total) Grade 3-4 0 0 0 0 1 1
Creatinine Grade 0-1 4 2 3 2 7 18
Creatinine Grade 2 1 1 0 1 2 5
Creatinine Grade 3-4 0 0 0 0 0 0
Hypercalcemia Grade 0-1 5 3 3 3 9 23
Hypercalcemia Grade 2 0 0 0 0 0 0
Hypercalcemia Grade 3-4 0 0 0 0 0 0
Hyperglycemia Grade 0-1 3 2 3 1 8 17
Hyperglycemia Grade 2 1 0 0 2 1 4
Hyperglycemia Grade 3-4 1 1 0 0 0 2
Hyperkalemia Grade 0 4 3 3 3 9 22
Hyperkalemia Grade 2 1 0 0 0 0 1
Hyperkalemia Grade 3-4 0 0 0 0 0 0
Hypermagnesemia Grade 0-1 5 3 3 3 9 23
Hypermagnesemia Grade 2 0 0 0 0 0 0
Hypermagnesemia Grade 3-4 0 0 0 0 0 0
Hypernatremia Grade 0-1 5 3 3 3 9 23
Hypernatremia Grade 2 0 0 0 0 0 0
Hypernatremia Grade 3-4 0 0 0 0 0 0
Hypoalbuminemia Grade 0-1 3 3 1 1 8 16
Hypoalbuminemia Grade 2 1 0 1 1 1 4
Hypoalbuminemia Grade 3-4 1 0 1 1 0 3
Hypocalcemia Grade 0-1 5 3 3 3 9 23
Hypocalcemia Grade 2 0 0 0 0 0 0
Hypocalcemia Grade 3 0 0 0 0 0 0
Hypoglycemia Grade 0-1 5 3 3 3 8 22
Hypoglycemia Grade 2 0 0 0 0 1 1
Hypoglycemia Grade 3-4 0 0 0 0 0 0
Hypokalemia Grade 0-1 5 3 3 2 8 21
Hypokalemia Grade 2 0 0 0 0 0 0
Hypokalemia Grade 3-4 0 0 0 1 1 2
Hypomagnesemia Grade 0-1 5 3 3 3 9 23
Hypomagnesemia Grade 2 0 0 0 0 0 0
Hypomagnesemia Grade 3-4 0 0 0 0 0 0
Hyponatremia Grade 0-1 4 3 2 2 8 19
Hyponatremia Grade 2 0 0 0 0 0 0
Hyponatremia Grade 3-4 1 0 1 1 1 4
Hypophosphatemia Grade 0-1 4 3 2 0 6 15
Hypophosphatemia Grade 2 1 0 1 1 3 6
Hypophosphatemia Grade 3-4 0 0 0 2 0 2
8.Secondary Outcome
Title Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern
Hide Description Vital sign summaries included all vital sign assessments from the on-treatment period. All vital sign parameters including blood pressure (BP) and weight were summarized using actual values and changes from baseline for each visit over time. The changes computed were the differences from baseline. The participants meeting criteria of potential clinical concern were judged by investigator.
Time Frame Baseline up to 28 days after the last dose of study drug, approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 study treatment, the participant was classified according to the first treatment received.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0
9.Secondary Outcome
Title Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study
Hide Description The ECOG shift from baseline to highest score during the on-treatment period was summarized by treatment group.ECOG Performance Status included 0, 1, 2, 3, and 4 grades. Grade 1 was Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 was Ambulatory and capable of all self care but unable to carry out any work activities.Up and about more than 50% of waking hours. Grade 3 was capable of only limited self care, confined to bed or chair more than 50% of waking hours. Grade 4 was completely disabled. Cannot carry on any self care. Totally confined to bed or chair.
Time Frame Baseline up to 28 days after the last dose of study drug, approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 study treatment, the participant was classified according to the first treatment received.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
ECOG Performance Status worst to 1 0 2 0 1 4 7
ECOG Performance Status worst to 2 2 0 0 0 0 2
ECOG Performance Status worst to 3 1 0 0 1 2 4
ECOG Performance Status worst to 4 and 5 0 0 0 0 0 0
10.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of PF-05082566
Hide Description Maximum PF-05082566 observed serum concentration.
Time Frame During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Overall Number of Participants Analyzed 4 1 3 3 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
7.628
(25%)
18.70 [1] 
(NA%)
29.80
(16%)
60.35
(39%)
95.57
(16%)
[1]
Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.
11.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of MK-3475
Hide Description Maximum MK-3475 observed serum concentration.
Time Frame During Cycle 5 Day 1 at pre-dose; and end of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Overall Number of Participants Analyzed 4 1 3 2 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
63350
(22%)
71300 [1] 
(NA%)
61090
(7%)
51920 [2] 
(NA%)
62030
(32%)
[1]
Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.
[2]
Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable. Individual subject values are 46000 and 58600 ng/mL, respectively
12.Secondary Outcome
Title Time for Cmax (Tmax) of PF-05082566
Hide Description Time to reach PF-05082566 maximum observed serum concentration.
Time Frame During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Overall Number of Participants Analyzed 4 1 3 3 4
Median (Full Range)
Unit of Measure: hour
1.44
(1.00 to 1.98)
5.40
(5.40 to 5.40)
1.07
(1.03 to 2.03)
1.08
(1.07 to 1.25)
1.15
(1.00 to 6.00)
13.Secondary Outcome
Title Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566
Hide Description PF-05082566 pre-dose concentration during multiple dosing
Time Frame During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Overall Number of Participants Analyzed 3 1 3 2 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
0.7489
(33%)
1.210 [1] 
(NA%)
1.664
(35%)
5.167 [2] 
(NA%)
7.796
(9%)
[1]
Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.
[2]
Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable.Individual subject values are 4.32 and 6.18 µg/mL, respectively.
14.Secondary Outcome
Title Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475
Hide Description MK-3475 pre-dose concentration during multiple dosing
Time Frame During Cycle 5 Day 1 at pre-dose; and end of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Overall Number of Participants Analyzed 4 1 3 3 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
18460
(33%)
19200 [1] 
(NA%)
20390
(15%)
11250
(78%)
17280
(46%)
[1]
Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.
15.Secondary Outcome
Title Terminal Half-life (t½)of PF-05082566
Hide Description PF-05082566 terminal half-life
Time Frame During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Overall Number of Participants Analyzed 3 1 3 2 4
Mean (Standard Deviation)
Unit of Measure: hour
179.3  (24.338) 173.0 [1]   (NA) 144.7  (31.628) 174.5 [2]   (NA) 164.8  (49.564)
[1]
Only 1 participant was analyzed, therefore the standard deviation was not applicable.
[2]
Only 2 participant were analyzed, therefore the standard deviation was not applicable. Individual subject values are 141and 208 hour, respectively.
16.Secondary Outcome
Title Clearance (CL) of Study Drug of PF-05082566
Hide Description Clearance of PF-05082566
Time Frame During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Overall Number of Participants Analyzed 3 1 3 2 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/hr/kg
0.4120
(32%)
0.5000 [1] 
(NA%)
0.5182
(41%)
0.3894 [2] 
(NA%)
0.4763
(25%)
[1]
Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.
[2]
Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable.Individual subject values are 0.254 and 0.597 mL/hr/kg, respectively.
17.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) of PF-05082566
Hide Description PF-05082566 volume of distribution at steady state
Time Frame During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Overall Number of Participants Analyzed 3 1 3 2 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/kg
101.4
(45%)
112.0 [1] 
(NA%)
104.0
(18%)
93.19 [2] 
(NA%)
104.6
(13%)
[1]
Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.
[2]
Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable. Individual subject values are 52.0 and 167 mL/kg, respectively.
18.Secondary Outcome
Title Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566
Hide Description PF-05082566 area under the serum concentration-time curve (AUC) from time 0 to time tau, the dosing interval, where tau = 504 hours (21 days) (AUCtau)
Time Frame During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Overall Number of Participants Analyzed 3 1 3 2 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg•hr/mL
1093
(32%)
1800 [1] 
(NA%)
3477
(41%)
9253 [2] 
(NA%)
10480
(25%)
[1]
Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.
[2]
Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable. Individual subject values are 6030 and 14200 µg•hr/mL, respectively.
19.Secondary Outcome
Title Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566
Hide Description ADA blood samples were assayed for anti-PF-05082566 antibodies using a validated analytical method in compliance with Pfizer (anti-PF-05082566) standard operating procedures (SOPs). ADA data was listed and summarized for PF 05082566 by dose. Negative ADA: titer<6.23; Positive ADA: titer>=6.23.Treatment-induced ADA = ADA developed de novo (seroconversion) following biologic drug administration. Treatment-boosted ADA = pre-existing ADA that were boosted to a higher level following biologic drug administration.
Time Frame Pre-dose (Day 1), Cycles 1, 3, 5, 7, and subsequently pre-dose (Day 1) every 2 cycles up to Cycle 12, and every 4 cycles thereafter
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Hide Analysis Population Description
The immunogenicity analysis set was a subset of the safety analysis set and included participants who have at least 1 ADA sample collected for either PF-05082566 or MK 3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
Pre-dose ADA 0 0 0 1 1 2
ADA Anytime 4 3 2 3 5 17
Treatment-induced ADA 4 3 2 2 4 15
Treatment-boosted ADA 0 0 0 0 0 0
Overall ADA Incidence 4 3 2 2 4 15
20.Secondary Outcome
Title Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475
Hide Description ADA blood samples were assayed for anti-MK-3475 antibodies using a validated analytical method in compliance with Merck (anti-MK-3475) SOPs.
Time Frame Pre-dose in Cycles 1, 3, 5, 7 and subsequently pre dose every 2 cycles up to Cycle 12 and every 4 cycles thereafter and 28 days, and during follow-up (3 months and 6 months after the end of MK-3475 treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity analysis set was a subset of the safety analysis set and included participants who have at least 1 ADA sample collected for either PF-05082566 or MK 3475.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0
21.Secondary Outcome
Title Number of Participants With Objective Tumor Response
Hide Description Objective response (OR) was defined as complete response (CR) or partial response (PR) according to RECIST version 1.1 from the date of first dose of study treatment until documented disease progression.CR = at least 2 determinations of CR at least 4 weeks apart and before progression; PR = at least 2 determinations of PR or better at least 4 weeks apart and before progression (and not qualifying for a CR); Progression of disease (PD) = progression<=12 weeks after the date of first dose of study treatment (and not qualifying for CR, PR, SD or non-CR/non-PD); Stable disease (SD) (applicable only to participants with measurable disease at baseline) = at least 1 SD assessment (or better)>=6 weeks after the date of first dose of study treatment and before progression (and not qualifying for CR or PR). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.
Time Frame Baseline, at Week 9, and then every 6 weeks up to 90 days after the last dose of study drug, approximately 27 months. For those patients who achieved a confirmed PR or CR, tumor assessments could be conducted as clinically indicated.
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Hide Analysis Population Description
The full analysis set (FAS) included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 treatment the participant was classified according to the first treatment received.
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg Total
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Overall Number of Participants Analyzed 5 3 3 3 9 23
Measure Type: Number
Unit of Measure: Participants
Complete response 0 0 1 0 1 2
Partial response 2 0 0 1 1 4
Stable disease 2 2 1 2 3 10
Objective progression 1 1 1 0 4 7
Objective response rate (CR+PR) 2 0 1 1 2 6
Time Frame Baseline up to 90 days after the last dose of study drug, approximately 27 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Hide Arm/Group Description PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
All-Cause Mortality
PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/5 (20.00%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/9 (0.00%) 
Hide Serious Adverse Events
PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/5 (40.00%)   0/3 (0.00%)   1/3 (33.33%)   2/3 (66.67%)   5/9 (55.56%) 
Blood and lymphatic system disorders           
Anaemia * 1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders           
Small intestinal obstruction * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
General disorders           
Disease progression * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Inflammation * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Hepatobiliary disorders           
Hyperbilirubinaemia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Infections and infestations           
Herpes simplex * 1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/9 (0.00%) 
Pneumonia * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Sinusitis * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Metabolism and nutrition disorders           
Hypocalcaemia * 1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/9 (0.00%) 
Hyponatraemia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Nervous system disorders           
Spinal cord compression * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Pleural effusion * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 5 mg/kg + MK-3475 2 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   9/9 (100.00%) 
Blood and lymphatic system disorders           
Anaemia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  3/9 (33.33%) 
Microcytic anaemia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Thrombocytopenia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Cardiac disorders           
Sinus tachycardia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Ear and labyrinth disorders           
Ear discomfort * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Ear pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Vertigo * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Endocrine disorders           
Adrenal insufficiency * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Hyperthyroidism * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Hypothyroidism * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Eye disorders           
Vision blurred * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders           
Abdominal pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/9 (22.22%) 
Abdominal pain upper * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Ascites * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Colitis * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Constipation * 1  0/5 (0.00%)  1/3 (33.33%)  2/3 (66.67%)  0/3 (0.00%)  3/9 (33.33%) 
Diarrhoea * 1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/9 (11.11%) 
Dry mouth * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/9 (22.22%) 
Dyspepsia * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/9 (22.22%) 
Gastrooesophageal reflux disease * 1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/9 (0.00%) 
Nausea * 1  3/5 (60.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  3/9 (33.33%) 
Oral discomfort * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Presbyoesophagus * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Small intestinal obstruction * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Stomatitis * 1  2/5 (40.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/9 (0.00%) 
Toothache * 1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/9 (0.00%) 
Vomiting * 1  2/5 (40.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  3/9 (33.33%) 
General disorders           
Administration site reaction * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Asthenia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/9 (33.33%) 
Chills * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Fatigue * 1  3/5 (60.00%)  1/3 (33.33%)  3/3 (100.00%)  0/3 (0.00%)  3/9 (33.33%) 
Influenza like illness * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Localised oedema * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Malaise * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Mucosal inflammation * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Oedema peripheral * 1  2/5 (40.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Pyrexia * 1  2/5 (40.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/9 (11.11%) 
Hepatobiliary disorders           
Hyperbilirubinaemia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Infections and infestations           
Bronchitis * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Candida infection * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Ear infection * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Fungal skin infection * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Gastroenteritis viral * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Hordeolum * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Otitis media * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Pneumonia * 1  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Sinusitis * 1  2/5 (40.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Upper respiratory tract infection * 1  3/5 (60.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Urinary tract infection * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Viral upper respiratory tract infection * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Injury, poisoning and procedural complications           
Fall * 1  2/5 (40.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Fracture * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Infusion related reaction * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Procedural pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Wound * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Investigations           
Alanine aminotransferase increased * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/9 (22.22%) 
Aspartate aminotransferase increased * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Blood alkaline phosphatase increased * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/9 (11.11%) 
Blood creatinine increased * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/9 (22.22%) 
Lymphocyte count decreased * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Platelet count decreased * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Weight decreased * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
White blood cell count decreased * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Metabolism and nutrition disorders           
Decreased appetite * 1  3/5 (60.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  4/9 (44.44%) 
Hyperglycaemia * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Hypoalbuminaemia * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Hypokalaemia * 1  1/5 (20.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/9 (11.11%) 
Hypomagnesaemia * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Hyponatraemia * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Hypophosphataemia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Malnutrition * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Back pain * 1  1/5 (20.00%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  0/9 (0.00%) 
Bone pain * 1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/9 (11.11%) 
Muscle spasms * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/9 (22.22%) 
Muscular weakness * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Musculoskeletal chest pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/9 (22.22%) 
Musculoskeletal pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Myalgia * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Neck pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Pain in extremity * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/9 (11.11%) 
Pain in jaw * 1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/9 (11.11%) 
Pathological fracture * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Tendon disorder * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Tumour pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Nervous system disorders           
Balance disorder * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/9 (11.11%) 
Cognitive disorder * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Dizziness * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Dysgeusia * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Headache * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Lethargy * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Memory impairment * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Migraine * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Neuropathy peripheral * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Peripheral motor neuropathy * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/9 (0.00%) 
Peripheral sensory neuropathy * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Product Issues           
Device breakage * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Psychiatric disorders           
Anxiety * 1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/9 (0.00%) 
Depression * 1  1/5 (20.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/9 (0.00%) 
Insomnia * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Renal and urinary disorders           
Dysuria * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Hydronephrosis * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Reproductive system and breast disorders           
Breast tenderness * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Pruritus genital * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders           
Bronchospasm * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Cough * 1  1/5 (20.00%)  3/3 (100.00%)  0/3 (0.00%)  0/3 (0.00%)  4/9 (44.44%) 
Dyspnoea * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/9 (11.11%) 
Epistaxis * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Haemoptysis * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/9 (22.22%) 
Nasal congestion * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Oropharyngeal pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Pleural effusion * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Pleuritic pain * 1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Pulmonary haemorrhage * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Rhinorrhoea * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Sinus congestion * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Sinus pain * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders           
Dry skin * 1  2/5 (40.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/9 (0.00%) 
Eczema * 1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/9 (0.00%) 
Erythema * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Hair texture abnormal * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Pruritus * 1  1/5 (20.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  4/9 (44.44%) 
Rash * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/9 (33.33%) 
Rash maculo-papular * 1  3/5 (60.00%)  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%)  0/9 (0.00%) 
Urticaria * 1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Vascular disorders           
Jugular vein thrombosis * 1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
The study was terminated early due to strategic reasons before any expansion cohort patient was enrolled.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02179918    
Other Study ID Numbers: B1641003
KEYNOTE-0036
First Submitted: June 30, 2014
First Posted: July 2, 2014
Results First Submitted: February 23, 2018
Results First Posted: October 11, 2018
Last Update Posted: February 8, 2019