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Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C)

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ClinicalTrials.gov Identifier: NCT01876511
Recruitment Status : Completed
First Posted : June 12, 2013
Results First Posted : January 7, 2020
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions MSI Positive Colorectal Cancer
MSI Negative Colorectal Cancer
MSI Positive Non-Colorectal Cancers
Intervention Drug: MK-3475
Enrollment 113
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description MK-3475: MK-3475 10 mg/kg every 14 days MK-3475: MK-3475 10 mg/kg every 14 days MK-3475: MK-3475 10 mg/kg every 14 days
Period Title: Overall Study
Started 41 25 47
Stages 1 and 2 24 25 21
Completed 18 0 16
Not Completed 23 25 31
Reason Not Completed
Disease Progression-clinical/radiologic             11             24             16
Death (unrelated)             3             0             2
Drug-related Toxicity             5             1             6
Patient Decision             3             0             6
Physician Decision             1             0             1
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer Total
Hide Arm/Group Description MK-3475: MK-3475 10 mg/kg every 14 days MK-3475: MK-3475 10 mg/kg every 14 days MK-3475: MK-3475 10 mg/kg every 14 days Total of all reporting groups
Overall Number of Baseline Participants 41 25 47 113
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 25 participants 47 participants 113 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
31
  75.6%
15
  60.0%
30
  63.8%
76
  67.3%
>=65 years
10
  24.4%
10
  40.0%
17
  36.2%
37
  32.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 25 participants 47 participants 113 participants
Female
19
  46.3%
9
  36.0%
23
  48.9%
51
  45.1%
Male
22
  53.7%
16
  64.0%
24
  51.1%
62
  54.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 25 participants 47 participants 113 participants
Hispanic or Latino
2
   4.9%
0
   0.0%
2
   4.3%
4
   3.5%
Not Hispanic or Latino
39
  95.1%
25
 100.0%
44
  93.6%
108
  95.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   2.1%
1
   0.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 25 participants 47 participants 113 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   7.3%
1
   4.0%
2
   4.3%
6
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   7.3%
3
  12.0%
1
   2.1%
7
   6.2%
White
34
  82.9%
21
  84.0%
44
  93.6%
99
  87.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.4%
0
   0.0%
0
   0.0%
1
   0.9%
1.Primary Outcome
Title Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2
Hide Description For Cohorts A and B: irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 20 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
It was a pre-specified objective to complete this objective in Cohort A and B only. Per protocol during stages 1 and 2, the study enrollment goal was 25 for Cohort A and B. However, only 24 subjects were enrolled in Cohort A. Additional subjects for this study were enrolled during the second expansion portion of this protocol.
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 24 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88
(75 to 100)
12
(4 to 36)
2.Primary Outcome
Title Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2
Hide Description For Cohorts A and B: Immune-related Objective Response Rate (irORR) is defined as the percentage of patients achieving a complete response (irCR) or partial response (irPR) based on irRC criteria. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation.
Time Frame 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
It was a pre-specified objective to complete this objective in Cohort A and B only. Per protocol during stages 1 and 2, the study enrollment goal was 25 for Cohort A and B. However, only 24 subjects were enrolled in Cohort A. Additional subjects for this study were enrolled during the second expansion portion of this protocol.
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 24 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67
(45 to 84)
0
(0 to 14)
3.Primary Outcome
Title Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive Non-colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2
Hide Description For Cohort C: irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 20 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
It was a pre-specified objective to complete this objective in Cohort C only. Per protocol during stages 1 and 2, the study enrollment goal was 21 for Cohort C. Additional subjects for this study were enrolled during the second expansion portion of this protocol.
Arm/Group Title Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67
(49 to 90)
4.Primary Outcome
Title Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Hide Description For Cohorts A and C: Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions.
Time Frame 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
It was a pre-specified objective to complete this objective in Cohort A and C only.
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 41 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54
(37 to 69)
55
(40 to 70)
5.Primary Outcome
Title Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Hide Description For Cohorts A and C: PFS is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 20 weeks. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
It was a pre-specified objective to complete this objective in Cohort A and C only.
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 41 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75
(63 to 90)
68
(56 to 83)
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 41 25 47
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(151.86 to NA)
36.71
(21.29 to 69.43)
148.86 [2] 
(94.71 to NA)
[1]
NA means that the median overall survival and upper bound confidence interval was not reached.
[2]
NA means that the upper bound confidence interval was not reached.
7.Secondary Outcome
Title Immune-related Progression Free Survival (irPFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Immune Related Response Criteria (irRC)
Hide Description irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 28 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
Time Frame 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 41 25 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70
(58 to 86)
12
(4 to 36)
64
(51 to 80)
8.Secondary Outcome
Title Objective Response Rate (ORR) in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Hide Description ORR is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions.
Time Frame 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 41 25 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54
(37 to 69)
0
(0 to 14)
55
(40 to 70)
9.Secondary Outcome
Title Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
Hide Description When calculating the incidence of AEs, each adverse event (AE) (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.
Time Frame 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 41 25 47
Measure Type: Count of Participants
Unit of Measure: Participants
12
  29.3%
0
   0.0%
13
  27.7%
10.Secondary Outcome
Title Progression Free Survival (PFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Hide Description PFS is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 28 weeks. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Time Frame 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 41 25 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70
(57 to 86)
16
(6 to 41)
64
(51 to 79)
11.Secondary Outcome
Title Disease Control Rate in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Hide Description Disease Control Rate (DCR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Time Frame 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 41 25 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80
(65 to 91)
16
(5 to 36)
70
(55 to 83)
12.Secondary Outcome
Title Does MSI as a Marker Predict Treatment Response
Hide Description ORR was used to determine whether MSI is a marker that predicts treatment response. This is the same data presented in outcome measure number 8 (ORR, to test against null of 5%).
Time Frame 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description:
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
MK-3475: MK-3475 10 mg/kg every 14 days
Overall Number of Participants Analyzed 41 25 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54
(37 to 69)
0
(0 to 14)
55
(40 to 70)
Time Frame 2 years 4 months Study treatment was administered for up to 2 years. Adverse events were accessed through 90 days after the last dose of study treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Hide Arm/Group Description MK-3475: MK-3475 10 mg/kg every 14 days MK-3475: MK-3475 10 mg/kg every 14 days MK-3475: MK-3475 10 mg/kg every 14 days
All-Cause Mortality
Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/41 (7.32%)      0/25 (0.00%)      2/47 (4.26%)    
Hide Serious Adverse Events
Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/41 (9.76%)      0/25 (0.00%)      7/47 (14.89%)    
Blood and lymphatic system disorders       
hemolytic anemia †  0/41 (0.00%)  0 0/25 (0.00%)  0 1/47 (2.13%)  1
Cardiac disorders       
Myocarditis †  1/41 (2.44%)  1 0/25 (0.00%)  0 1/47 (2.13%)  1
Gastrointestinal disorders       
Pancreatitis †  1/41 (2.44%)  1 0/25 (0.00%)  0 1/47 (2.13%)  1
Diarrhea †  0/41 (0.00%)  0 0/25 (0.00%)  0 1/47 (2.13%)  1
Colitis †  0/41 (0.00%)  0 0/25 (0.00%)  0 1/47 (2.13%)  1
Hepatobiliary disorders       
Alanine aminotransferase Increased (ALT) †  0/41 (0.00%)  0 0/25 (0.00%)  0 1/47 (2.13%)  1
Aspartate aminotransferase increased (AST) †  0/41 (0.00%)  0 0/25 (0.00%)  0 1/47 (2.13%)  1
Alkaline Phosphate elevated †  0/41 (0.00%)  0 0/25 (0.00%)  0 1/47 (2.13%)  1
Infections and infestations       
Cellulitis †  1/41 (2.44%)  1 0/25 (0.00%)  0 0/47 (0.00%)  0
Metabolism and nutrition disorders       
Diabetic ketoacidosis †  0/41 (0.00%)  0 0/25 (0.00%)  0 2/47 (4.26%)  2
Musculoskeletal and connective tissue disorders       
Arthritis †  1/41 (2.44%)  1 0/25 (0.00%)  0 0/47 (0.00%)  0
Nervous system disorders       
Neuropathy †  0/41 (0.00%)  0 0/25 (0.00%)  0 1/47 (2.13%)  1
Product Issues       
Infusion reaction †  1/41 (2.44%)  1 0/25 (0.00%)  0 0/47 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury †  1/41 (2.44%)  1 0/25 (0.00%)  0 0/47 (0.00%)  0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A: MSI Positive Colorectal Cancer Cohort B: MSI Negative Colorectal Cancer Cohort C: MSI Positive Non-Colorectal Cancer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/41 (100.00%)      3/25 (12.00%)      47/47 (100.00%)    
Blood and lymphatic system disorders       
Anemia †  3/41 (7.32%)  3 0/25 (0.00%)  0 4/47 (8.51%)  4
Endocrine disorders       
Hypothyroidism/thyroiditis †  6/41 (14.63%)  6 0/25 (0.00%)  0 13/47 (27.66%)  13
Gastrointestinal disorders       
Diarrhea †  10/41 (24.39%)  10 0/25 (0.00%)  0 9/47 (19.15%)  9
Nausea †  5/41 (12.20%)  5 0/25 (0.00%)  0 8/47 (17.02%)  8
General disorders       
Fatigue † [1]  8/41 (19.51%)  8 1/25 (4.00%)  1 13/47 (27.66%)  13
Investigations       
Alanine aminotransferase Increased (ALT) †  3/41 (7.32%)  3 0/25 (0.00%)  0 3/47 (6.38%)  3
Aspartate aminotransferase increased (AST) †  4/41 (9.76%)  4 0/25 (0.00%)  0 5/47 (10.64%)  5
Lymphocyte count decreased †  2/41 (4.88%)  2 0/25 (0.00%)  0 5/47 (10.64%)  5
White blood cell decreased †  3/41 (7.32%)  3 0/25 (0.00%)  0 3/47 (6.38%)  3
Musculoskeletal and connective tissue disorders       
Arthralgia †  7/41 (17.07%)  7 0/25 (0.00%)  0 4/47 (8.51%)  4
Nervous system disorders       
Neuropathy †  1/41 (2.44%)  1 0/25 (0.00%)  0 5/47 (10.64%)  5
Skin and subcutaneous tissue disorders       
Pruritus †  6/41 (14.63%)  6 0/25 (0.00%)  0 13/47 (27.66%)  13
Rash †  10/41 (24.39%)  10 2/25 (8.00%)  2 15/47 (31.91%)  15
†
Indicates events were collected by systematic assessment
[1]
and administration site conditions
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dung Le, MD
Organization: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 443-287-0002
EMail: dle@jhmi.edu
Publications:
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01876511    
Other Study ID Numbers: J1365 (Cohort A, B and C)
MK-3475-016 ( Other Identifier: Merck )
NA_00085756 ( Other Identifier: JHMIRB )
First Submitted: June 10, 2013
First Posted: June 12, 2013
Results First Submitted: November 6, 2019
Results First Posted: January 7, 2020
Last Update Posted: February 6, 2020