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A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies (MEDI6469)

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ClinicalTrials.gov Identifier: NCT02205333
Recruitment Status : Terminated (The study was terminated early at the sponsor's discretion.)
First Posted : July 31, 2014
Results First Posted : May 8, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Solid Tumors
Aggressive B-cell Lymphomas
Interventions Biological: MEDI6469 Monotherapy
Biological: MEDI6469 Plus Tremelimumab
Biological: MEDI6469 Plus Durvalumab
Biological: MEDI6469 plus Rituximab
Enrollment 48
Recruitment Details A total of 58 participants were screened at 13 sites in the United States of America (USA).
Pre-assignment Details A total of 58 participants were screened for this study, of which 48 participants were enrolled and received study treatment.
Arm/Group Title MEDI6469 6 Milligram/Kilogram (mg/kg) MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+Rituximab 375 mg/m^2 MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Hide Arm/Group Description Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1 Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Period Title: Overall Study
Started 8 6 3 7 6 7 7 3 1
Completed 2 0 1 0 1 4 2 1 1
Not Completed 6 6 2 7 5 3 5 2 0
Reason Not Completed
Death             5             6             2             6             5             3             3             2             0
Withdrawal by Subject             1             0             0             1             0             0             2             0             0
Arm/Group Title MEDI6469 6 Milligram/Kilogram (mg/kg) MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+Rituximab 375 mg/m^2 MEDI6469 10 mg/kg+Rituximab 375 mg/m^2 Total
Hide Arm/Group Description Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1 Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD Total of all reporting groups
Overall Number of Baseline Participants 8 6 3 7 6 7 7 3 1 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 3 participants 7 participants 6 participants 7 participants 7 participants 3 participants 1 participants 48 participants
60.5  (12.6) 63.8  (8.9) 48.0  (6.9) 61.3  (8.7) 57.5  (19.4) 66.6  (14.5) 62.6  (9.1) 70.3  (4.6) 73.0 [1]   (NA) 61.9  (12.2)
[1]
Not evaluable due to insufficient number of participants.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 3 participants 7 participants 6 participants 7 participants 7 participants 3 participants 1 participants 48 participants
Female
5
  62.5%
3
  50.0%
2
  66.7%
2
  28.6%
3
  50.0%
1
  14.3%
3
  42.9%
1
  33.3%
0
   0.0%
20
  41.7%
Male
3
  37.5%
3
  50.0%
1
  33.3%
5
  71.4%
3
  50.0%
6
  85.7%
4
  57.1%
2
  66.7%
1
 100.0%
28
  58.3%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of MEDI6469
Hide Description The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.
Time Frame From the first dose of study treatment through 28 days after the first dose (up to 28 days)
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Hide Analysis Population Description
DLT-evaluable population: All participants enrolled in the dose-escalation phase who received study treatment per protocol during the first 28 days and completed safety follow-up through the DLT-evaluation period or experienced any DLT.
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: milligram per kilogram (mg/kg)
NA [1]  NA [1]  NA [2]  NA [2]  NA [1]  NA [1]  NA [1]  NA [2]  NA [2] 
[1]
Dose escalation was completed without determination of MTD.
[2]
Dose escalation was terminated early prior to completion of the protocol-specified dose ranges.
2.Primary Outcome
Title Number of Participants With DLTs
Hide Description The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal [ULN] or total bilirubin higher than 5×ULN; any >=Grade 2 pneumonitis that did not resolve to <=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (<=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to <=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (>=) Grade 3 lymphopenia (unless clinically significant).
Time Frame From the first dose of study treatment through 28 days after the first dose (up to 28 days)
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Hide Analysis Population Description
DLT-evaluable population
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: Participant
0 0 0 1 1 1 0 0 0
3.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.
Time Frame From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
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As-treated population: all the participants who received any study treatment.
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: Participant
8 6 3 7 6 7 7 3 1
4.Primary Outcome
Title Number of Participants With Treatment-emergent Serious Adverse Events
Hide Description A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.
Time Frame From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: Participant
4 3 1 5 3 3 3 2 0
5.Primary Outcome
Title Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hide Description Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen [BUN], bicarbonate, glucose, aspartate transaminase [AST], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase [GGT], lactate dehydrogenase, uric acid, potassium, alanine transaminase [ALT], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.
Time Frame From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
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Hide Analysis Population Description
As-treated population
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: Participant
Anemia 2 2 2 2 2 1 3 1 1
Neutrophil count increased 1 0 0 0 0 0 0 0 0
Neutrophil count decreased 0 0 2 0 0 0 0 0 0
Lymphopenia 1 0 0 0 1 0 0 0 0
Blood iron decreased 0 0 0 0 1 0 0 0 0
Hemoglobin decreased 1 0 0 0 0 0 0 0 0
Lymphocyte count decreased 0 0 0 0 1 0 0 0 0
Neutropenia 0 0 0 0 0 0 0 0 1
Platelet count decreased 0 0 0 0 0 1 0 0 0
Thrombocytopenia 0 0 0 0 0 0 0 0 1
Hypernatremia 1 1 1 3 2 0 2 0 0
Hypokalemia 1 1 1 2 1 1 1 1 0
Aspartate aminotransferase increased 1 0 0 3 1 1 1 0 1
Hypomagnesemia 1 1 0 0 2 1 1 1 0
Blood alkaline phosphatase increased 0 0 1 1 2 1 0 0 0
Hyperglycemia 2 0 1 1 1 0 0 0 0
Alanine aminotransferase increased 1 0 0 1 0 1 1 0 0
Blood creatinine increased 0 0 0 1 2 0 0 0 1
Gamma-glutamyltransferase increased 1 0 0 1 2 0 0 0 0
Hypercalcemia 2 1 0 0 0 0 0 1 0
Hyperkalemia 0 0 2 0 2 0 0 0 0
Hypoalbuminemia 1 0 0 0 2 1 0 0 0
Hyperuricemia 0 0 0 0 1 0 0 1 1
Blood bilirubin increased 0 0 0 1 0 1 0 0 0
Hypophosphatemia 1 0 0 0 0 1 0 0 0
Blood cholesterol increased 0 0 1 0 0 0 0 0 0
Blood glucose increased 0 0 0 0 0 0 0 1 0
Blood thyroid stimulating hormone increased 0 0 0 0 1 0 0 0 0
Hypocalcemia 0 1 0 0 0 0 0 0 0
Hypothyroidism 0 0 0 0 1 0 0 0 0
Iron deficiency 0 1 0 0 0 0 0 0 0
Liver function test increased 0 0 0 1 0 0 0 0 0
Tri-iodothyronine free decreased 0 0 0 0 1 0 0 0 0
Troponin increased 0 0 0 0 0 1 0 0 0
Thyroxine free decreased 0 0 0 0 1 0 0 0 0
Hematuria 0 0 1 0 0 0 0 0 0
Activated partial thromboplastin time prolonged 0 0 0 0 1 0 0 1 0
6.Primary Outcome
Title Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Hide Description Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.
Time Frame From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
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Hide Analysis Population Description
As-treated population
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: Participant
Pyrexia 1 2 2 2 0 3 2 0 0
Dyspnea 0 2 1 0 1 2 1 0 1
Hypotension 0 0 0 1 1 1 1 0 0
Sinus tachycardia 0 0 0 1 0 1 0 1 0
Dyspnea exertional 0 0 0 0 1 1 0 0 0
Tachycardia 0 0 1 0 0 1 0 0 0
Bradycardia 0 0 0 0 0 1 0 0 0
Hypertension 0 0 1 0 0 0 0 0 0
Hypoxia 0 0 0 1 0 0 0 0 0
Wheezing 0 0 0 0 0 1 0 0 0
7.Primary Outcome
Title Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs
Hide Description Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.
Time Frame From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
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As-treated population
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: Participant
0 0 0 0 0 0 0 0 0
8.Secondary Outcome
Title Best Overall Response (BOR)
Hide Description Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.
Time Frame From study entry until early termination (up to 1 year)
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As-treated population
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: Percentage of participants
CR 0 0 0 0 0 0 0 0 0
PR 0 0 0 0 16.7 0 0 0 0
SD 12.5 0 33.3 28.6 33.3 14.3 0 33.3 100.0
PD 50.0 33.3 66.7 42.9 50.0 42.9 100.0 66.7 0
NE 37.5 66.7 0 28.6 0 42.9 0 0 0
9.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment >= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.
Time Frame From study entry until early termination (up to 1 year)
Hide Outcome Measure Data
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As-treated population
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0 0 16.7 0 0 0 0
10.Secondary Outcome
Title Disease Control Rate
Hide Description Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for >= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.
Time Frame From study entry until early termination (up to 1 year)
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As-treated population
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: Percentage of participants
12.5 0 33.3 28.6 50.0 14.3 0 33.3 100.0
11.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.
Time Frame From Study entry until early termination (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants with an OR were included.
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 0 0 0 0 1 0 0 0 0
Measure Type: Number
Unit of Measure: Days
368
12.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.
Time Frame From Study entry until early termination (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Median (95% Confidence Interval)
Unit of Measure: Months
1.8
(0.9 to 3.5)
1.8
(1.8 to 1.8)
1.9
(1.8 to 6.4)
2.8
(0.7 to 6.7)
5.6
(1.0 to 17.8)
1.8
(1.0 to 6.4)
1.4
(1.0 to 1.8)
1.0 [1] 
(0.9 to NA)
5.4 [1] 
(NA to NA)
[1]
Not evaluable due to insufficient number of participants achieved this endpoint
13.Secondary Outcome
Title Overall Survival (OS)
Hide Description The OS was the duration from the start of study treatment until death due to any cause.
Time Frame From Study entry until early termination (up to 1 year)
Hide Outcome Measure Data
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As-treated population
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Median (95% Confidence Interval)
Unit of Measure: Months
6.1 [1] 
(0.9 to NA)
6.5
(1.8 to 10.7)
13.1 [1] 
(11.2 to NA)
6.7
(2.0 to 12.5)
11.2
(1.2 to 17.8)
NA [1] 
(1.0 to NA)
2.9 [1] 
(2.5 to NA)
3.3 [1] 
(1.7 to NA)
NA [1] 
(NA to NA)
[1]
Not evaluable due to insufficient number of participants achieved this endpoint
14.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax)
Hide Description The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
Time Frame MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter
133.76  (34.87) 188.87  (59.88) 49.00  (1.29) 43.67  (7.99) 40.21  (8.20) 42.10  (6.63) 234.91  (56.05) 31.68  (5.06) 289.40 [1]   (NA)
[1]
Not evaluable due to insufficient number of participants achieved this endpoint
15.Secondary Outcome
Title Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
Hide Description The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
Time Frame MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Mean (Standard Deviation)
Unit of Measure: day*microgram per milliliter
556.92  (166.95) 873.16  (328.74) 169.34  (18.15) 183.09  (26.27) 144.91  (33.07) 169.65  (45.98) 998.25  (400.12) 145.55  (16.86) 1619.73 [1]   (NA)
[1]
Not evaluable due to insufficient number of participants achieved this endpoint
16.Secondary Outcome
Title Systemic Clearance (CL)
Hide Description The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
Time Frame MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Mean (Standard Deviation)
Unit of Measure: liter per day
0.81  (0.224) 0.84  (0.246) 1.02  (0.155) 0.89  (0.132) 1.04  (0.288) 1.0  (0.266) 0.84  (0.173) 1.11  (0.188) 0.77 [1]   (NA)
[1]
Not evaluable due to insufficient number of participants achieved this endpoint
17.Secondary Outcome
Title Terminal Phase Elimination Half-Life (T1/2)
Hide Description The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
Time Frame MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Mean (Standard Deviation)
Unit of Measure: Day
2.83  (0.83) 3.20  (1.23) 1.56  (0.04) 2.86  (0.68) 2.73  (0.65) 3.30  (0.68) 2.98  (1.06) 3.75  (1.03) 4.19 [1]   (NA)
[1]
Not evaluable due to insufficient number of participants achieved this endpoint
18.Secondary Outcome
Title Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)
Hide Description The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).
Time Frame All treatment arms: Days 8, 15, 29, and end of treatment (up to 1 year). Additionally for MEDI6469 + rituximab arm: Days 3, 31, 59, and every 28 days thereafter until end of treatment (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants who received at least a one dose of MEDI6469.
Arm/Group Title MEDI6469 6 mg/kg MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2 MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Overall Number of Participants Analyzed 8 6 3 7 6 7 7 3 1
Measure Type: Number
Unit of Measure: Participant
5 4 3 6 5 6 4 1 0
Time Frame From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MEDI6469 6 Milligram/Kilogram (mg/kg) MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+Rituximab 375 mg/m^2 MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Hide Arm/Group Description Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1 Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
All-Cause Mortality
MEDI6469 6 Milligram/Kilogram (mg/kg) MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+Rituximab 375 mg/m^2 MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
MEDI6469 6 Milligram/Kilogram (mg/kg) MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+Rituximab 375 mg/m^2 MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/8 (50.00%)      3/6 (50.00%)      1/3 (33.33%)      5/7 (71.43%)      3/6 (50.00%)      3/7 (42.86%)      3/7 (42.86%)      2/3 (66.67%)      0/1 (0.00%)    
Blood and lymphatic system disorders                   
Anaemia  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 1/7 (14.29%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0
Cardiac disorders                   
Atrial fibrillation  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Atrial flutter  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Endocrine disorders                   
Hypothyroidism  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders                   
Abdominal pain  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  2 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Ascites  1  2/8 (25.00%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Diarrhoea  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Nausea  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Retroperitoneal haemorrhage  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Vomiting  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 1/7 (14.29%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
General disorders                   
Asthenia  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  2 1/3 (33.33%)  1 0/1 (0.00%)  0
Oedema peripheral  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations                   
Gastroenteritis  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Infection  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Lung infection  1  0/8 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Pleural infection  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Pneumonia  1  2/8 (25.00%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0 2/7 (28.57%)  2 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Sepsis  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Skin infection  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Wound infection  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Investigations                   
Platelet count decreased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Metabolism and nutrition disorders                   
Dehydration  1  0/8 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1 0/7 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hypercalcaemia  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Hypokalaemia  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Malnutrition  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Arthralgia  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Muscular weakness  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Pain in extremity  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Nervous system disorders                   
Encephalopathy  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Myoclonus  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders                   
Delirium  1  0/8 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Mental status changes  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Renal and urinary disorders                   
Acute kidney injury  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Obstructive uropathy  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Reproductive system and breast disorders                   
Scrotal swelling  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Pleural effusion  1  0/8 (0.00%)  0 1/6 (16.67%)  2 0/3 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Pleuritic pain  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Pneumonitis  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Pulmonary embolism  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Vascular disorders                   
Deep vein thrombosis  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MEDI6469 6 Milligram/Kilogram (mg/kg) MEDI6469 10 mg/kg MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg MEDI6469 2 mg/kg+Durvalumab 3 mg/kg MEDI6469 2 mg/kg+Durvalumab 10 mg/kg MEDI6469 10 mg/kg+Durvalumab 10 mg/kg MEDI6469 2 mg/kg+Rituximab 375 mg/m^2 MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/8 (75.00%)      6/6 (100.00%)      3/3 (100.00%)      7/7 (100.00%)      6/6 (100.00%)      7/7 (100.00%)      7/7 (100.00%)      3/3 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders                   
Anaemia  1  2/8 (25.00%)  3 2/6 (33.33%)  3 2/3 (66.67%)  3 2/7 (28.57%)  3 1/6 (16.67%)  2 1/7 (14.29%)  1 2/7 (28.57%)  2 1/3 (33.33%)  1 1/1 (100.00%)  1
Cardiac disorders                   
Sinus tachycardia  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  2 1/3 (33.33%)  1 0/1 (0.00%)  0
Gastrointestinal disorders                   
Abdominal pain  1  1/8 (12.50%)  1 0/6 (0.00%)  0 1/3 (33.33%)  2 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 2/7 (28.57%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0
Constipation  1  1/8 (12.50%)  3 1/6 (16.67%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 3/6 (50.00%)  3 3/7 (42.86%)  3 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Diarrhoea  1  0/8 (0.00%)  0 2/6 (33.33%)  2 1/3 (33.33%)  2 4/7 (57.14%)  9 1/6 (16.67%)  1 1/7 (14.29%)  1 3/7 (42.86%)  3 0/3 (0.00%)  0 0/1 (0.00%)  0
Gastrooesophageal reflux disease  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Nausea  1  3/8 (37.50%)  4 2/6 (33.33%)  3 1/3 (33.33%)  1 4/7 (57.14%)  5 3/6 (50.00%)  5 2/7 (28.57%)  2 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Vomiting  1  1/8 (12.50%)  1 1/6 (16.67%)  3 1/3 (33.33%)  1 3/7 (42.86%)  3 2/6 (33.33%)  2 2/7 (28.57%)  2 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
General disorders                   
Asthenia  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 2/7 (28.57%)  2 0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Chills  1  2/8 (25.00%)  2 0/6 (0.00%)  0 1/3 (33.33%)  1 3/7 (42.86%)  3 0/6 (0.00%)  0 2/7 (28.57%)  2 2/7 (28.57%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0
Fatigue  1  3/8 (37.50%)  5 2/6 (33.33%)  2 3/3 (100.00%)  5 4/7 (57.14%)  6 4/6 (66.67%)  4 3/7 (42.86%)  3 3/7 (42.86%)  4 1/3 (33.33%)  3 1/1 (100.00%)  2
Influenza like illness  1  2/8 (25.00%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 1/6 (16.67%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Non-cardiac chest pain  1  0/8 (0.00%)  0 2/6 (33.33%)  2 1/3 (33.33%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Oedema peripheral  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 2/7 (28.57%)  2 2/6 (33.33%)  2 1/7 (14.29%)  1 1/7 (14.29%)  1 1/3 (33.33%)  1 1/1 (100.00%)  1
Pyrexia  1  1/8 (12.50%)  2 2/6 (33.33%)  2 2/3 (66.67%)  2 2/7 (28.57%)  2 0/6 (0.00%)  0 3/7 (42.86%)  3 2/7 (28.57%)  4 0/3 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations                   
Bronchitis  1  0/8 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Urinary tract infection  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  2 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0
Investigations                   
Alanine aminotransferase increased  1  1/8 (12.50%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  2 0/6 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  3 0/3 (0.00%)  0 0/1 (0.00%)  0
Aspartate aminotransferase increased  1  1/8 (12.50%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0 3/7 (42.86%)  4 1/6 (16.67%)  1 1/7 (14.29%)  1 1/7 (14.29%)  1 0/3 (0.00%)  0 1/1 (100.00%)  2
Blood alkaline phosphatase increased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  2 1/7 (14.29%)  2 2/6 (33.33%)  2 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Blood creatinine increased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  4 2/6 (33.33%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Gamma-glutamyltransferase increased  1  1/8 (12.50%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 2/6 (33.33%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Metabolism and nutrition disorders                   
Decreased appetite  1  1/8 (12.50%)  2 3/6 (50.00%)  3 1/3 (33.33%)  3 3/7 (42.86%)  4 2/6 (33.33%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Dehydration  1  1/8 (12.50%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1 1/7 (14.29%)  1 1/6 (16.67%)  1 1/7 (14.29%)  1 2/7 (28.57%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0
Hypercalcaemia  1  2/8 (25.00%)  3 1/6 (16.67%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hyperglycaemia  1  2/8 (25.00%)  2 0/6 (0.00%)  0 1/3 (33.33%)  3 1/7 (14.29%)  1 1/6 (16.67%)  4 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hyperkalaemia  1  0/8 (0.00%)  0 0/6 (0.00%)  0 2/3 (66.67%)  2 0/7 (0.00%)  0 2/6 (33.33%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hyperuricaemia  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 1/3 (33.33%)  1 1/1 (100.00%)  1
Hypoalbuminaemia  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 2/6 (33.33%)  2 1/7 (14.29%)  2 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hypokalaemia  1  1/8 (12.50%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1 2/7 (28.57%)  2 1/6 (16.67%)  1 1/7 (14.29%)  1 1/7 (14.29%)  1 1/3 (33.33%)  2 0/1 (0.00%)  0
Hypomagnesaemia  1  1/8 (12.50%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 2/6 (33.33%)  2 1/7 (14.29%)  1 1/7 (14.29%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0
Hyponatraemia  1  1/8 (12.50%)  1 1/6 (16.67%)  1 1/3 (33.33%)  2 3/7 (42.86%)  3 2/6 (33.33%)  2 0/7 (0.00%)  0 2/7 (28.57%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Arthralgia  1  1/8 (12.50%)  5 1/6 (16.67%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 2/6 (33.33%)  3 1/7 (14.29%)  1 2/7 (28.57%)  3 0/3 (0.00%)  0 0/1 (0.00%)  0
Back pain  1  0/8 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  2 0/7 (0.00%)  0 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Bone pain  1  2/8 (25.00%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 1/7 (14.29%)  2 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Myalgia  1  1/8 (12.50%)  2 2/6 (33.33%)  2 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 2/7 (28.57%)  2 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Pain in extremity  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 2/7 (28.57%)  2 1/3 (33.33%)  2 0/1 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Tumour flare  1  2/8 (25.00%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0 1/7 (14.29%)  2 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Tumour pain  1  2/8 (25.00%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders                   
Dizziness  1  1/8 (12.50%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1 0/7 (0.00%)  0 2/6 (33.33%)  3 2/7 (28.57%)  2 0/7 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Headache  1  3/8 (37.50%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 3/6 (50.00%)  3 1/7 (14.29%)  1 2/7 (28.57%)  2 0/3 (0.00%)  0 1/1 (100.00%)  1
Neuropathy peripheral  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders                   
Anxiety  1  0/8 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/3 (33.33%)  1 1/1 (100.00%)  3
Insomnia  1  1/8 (12.50%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 1/6 (16.67%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1 0/3 (0.00%)  0 1/1 (100.00%)  2
Respiratory, thoracic and mediastinal disorders                   
Cough  1  1/8 (12.50%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 1/6 (16.67%)  1 2/7 (28.57%)  2 0/7 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Dyspnoea  1  0/8 (0.00%)  0 2/6 (33.33%)  5 1/3 (33.33%)  2 0/7 (0.00%)  0 1/6 (16.67%)  1 2/7 (28.57%)  2 1/7 (14.29%)  1 0/3 (0.00%)  0 1/1 (100.00%)  1
Oropharyngeal pain  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Pleural effusion  1  0/8 (0.00%)  0 1/6 (16.67%)  2 1/3 (33.33%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Hyperhidrosis  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 2/7 (28.57%)  2 0/6 (0.00%)  0 2/7 (28.57%)  2 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Night sweats  1  2/8 (25.00%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 2/6 (33.33%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Pruritus  1  3/8 (37.50%)  3 0/6 (0.00%)  0 1/3 (33.33%)  2 3/7 (42.86%)  3 3/6 (50.00%)  3 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Rash  1  2/8 (25.00%)  2 0/6 (0.00%)  0 1/3 (33.33%)  2 2/7 (28.57%)  2 1/6 (16.67%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Rash maculo-papular  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Rash pruritic  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 1/3 (33.33%)  2 0/1 (0.00%)  0
Vascular disorders                   
Hypotension  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 1/6 (16.67%)  1 1/7 (14.29%)  2 1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
The study was terminated early at the Sponsor's discretion.
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.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Victoria Chiou
Organization: MedImmune, LLC
Phone: 301-398-4330
EMail: chiouv@MedImmune.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02205333    
Other Study ID Numbers: D4981C00001
First Submitted: July 18, 2014
First Posted: July 31, 2014
Results First Submitted: March 27, 2017
Results First Posted: May 8, 2017
Last Update Posted: June 28, 2017