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A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02212730
Recruitment Status : Terminated (Terminated early due to low enrollment)
First Posted : August 8, 2014
Results First Posted : July 16, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Cancer
Interventions Drug: Pembrolizumab Pre-Resection
Procedure: Surgical Resection
Drug: Pembrolizumab Post-Resection
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection RCC Resection
Hide Arm/Group Description Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04. Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
Period Title: Overall Study
Started 6 4
Received Neoadjuvant Pembrolizumab 4 0
Underwent RCC 4 3
Received Post-RCC Pembrolizumab 1 1
Completed 4 3
Not Completed 2 1
Reason Not Completed
Tumor not of the required cell histology             1             0
Withdrawal by Subject             1             0
Disease progression prior to RCC surgery             0             1
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection RCC Resection Total
Hide Arm/Group Description Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04. Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04. Total of all reporting groups
Overall Number of Baseline Participants 6 4 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 4 participants 10 participants
66.5  (5.2) 55.3  (9.1) 62.0  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
Female
1
  16.7%
2
  50.0%
3
  30.0%
Male
5
  83.3%
2
  50.0%
7
  70.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
4
 100.0%
10
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  16.7%
2
  50.0%
3
  30.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
5
  83.3%
2
  50.0%
7
  70.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With an Adverse Event (AE) During the Neoadjuvant Pembrolizumab Regimen
Hide Description An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE during their regimen of neoadjuvant pembrolizumab was presented.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab.
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
2.Primary Outcome
Title Number of Participants Who Discontinued Treatment Due to an Adverse Event
Hide Description An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study drug due to an adverse event is presented.
Time Frame Up to 56 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received ≥1 dose of pembrolizumab. Participants in the RCC Resection arm only received pembrolizumab if they enrolled under protocol amendment 04. Counts were based on which course of pembrolizumab (neoadjuvant or post-resection) a participant was receiving at the time of discontinuation.
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection RCC Resection
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
Overall Number of Participants Analyzed 4 1
Measure Type: Count of Participants
Unit of Measure: Participants
During neoadjuvant pembrolizumab Number Analyzed 4 participants 0 participants
0
   0.0%
0
During post-RCC resection pembrolizumab Number Analyzed 1 participants 1 participants
1
 100.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD3+ Lymphocytic Infiltration
Hide Description The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral CD3+ lymphocytic infiltration is presented. Evaluations were based on pathologist score.
Time Frame Baseline and Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab and whose samples were evaluable.
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
4.Primary Outcome
Title Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD8+ Lymphocytic Infiltration
Hide Description The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral CD8+ lymphocytic infiltration is presented. Evaluations were based on pathologist score.
Time Frame Baseline and Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab and whose samples were evaluable.
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
5.Primary Outcome
Title Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral FoxP3+ Lymphocytic Infiltration
Hide Description The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral FoxP3+ (forkhead box protein P3 positive) lymphocytic infiltration is presented. Evaluations were based on pathologist score.
Time Frame Baseline and Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab and whose samples were evaluable.
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title Change From Baseline in Levels of Gene Expression of Immune Modulatory Receptors in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
Hide Description The change from baseline in levels of gene expression of immune modulatory receptors in tumors of participants treated with neoadjuvant pembrolizumab was presented.
Time Frame Baseline and Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was planned to consist of all participants who received ≥1 dose of neoadjuvant pembrolizumab. Due to low enrollment, there is no data to analyze for this outcome measure and therefore all participants were excluded from analysis.
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection RCC Resection
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in Number of T Cells in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
Hide Description The change from baseline in number of T cells in tumors of participants treated with neoadjuvant pembrolizumab was presented.
Time Frame Baseline and Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was planned to consist of all participants who received ≥1 dose of neoadjuvant pembrolizumab. Due to low enrollment, there is no data to analyze for this outcome measure and therefore all participants were excluded from analysis.
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection RCC Resection
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Baseline in Number of Activated T Cells in Peripheral Blood of Participants Treated With Neoadjuvant Pembrolizumab
Hide Description The change from baseline in the number of activated T cells in peripheral blood of participants treated with neoadjuvant pembrolizumab was presented.
Time Frame Baseline and Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was planned to consist of all participants who received ≥1 dose of neoadjuvant pembrolizumab. Due to low enrollment, there is no data to analyze for this outcome measure and therefore all participants were excluded from analysis.
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection RCC Resection
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change From Baseline in Levels of Programmed Cell Death 1 Ligand 1 (PD-L1) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
Hide Description The change from baseline in levels of programmed cell death 1 ligand 1 (PD-L1) protein in tumors of participants treated with neoadjuvant pembrolizumab in participants who received neoadjuvant pembrolizumab was presented.
Time Frame Baseline and Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was planned to consist of all participants who received ≥1 dose of neoadjuvant pembrolizumab. Due to low enrollment, there is no data to analyze for this outcome measure and therefore all participants were excluded from analysis.
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection RCC Resection
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change From Baseline in Levels of Programmed Cell Death 1 Ligand 2 (PD-L2) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
Hide Description The change from baseline in levels of programmed cell death 1 ligand 2 (PD-L2) protein in tumors of participants treated with neoadjuvant pembrolizumab in participants who received neoadjuvant pembrolizumab was presented.
Time Frame Baseline and Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was planned to consist of all participants who received ≥1 dose of neoadjuvant pembrolizumab. Due to low enrollment, there is no data to analyze for this outcome measure and therefore all participants were excluded from analysis.
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection RCC Resection
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 77 weeks
Adverse Event Reporting Description

Adverse events are reported only for participants who received treatment as described in each arm's description. Deaths are reported for all participants who enrolled, regardless of whether they received treatment.

Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless it resulted in hospitalization or death.

 
Arm/Group Title Neoadjuvant Pembrolizumab + RCC Resection Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab SOC RCC Resection RCC Resection + Post-Resection Pembrolizumab
Hide Arm/Group Description Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04. Adverse events in this arm are only counted until 30 days after RCC resection for non-serious adverse events, 90 days for serious adverse events, or until a participant started the post-surgery course of pembrolizumab, whichever occurred first. Deaths are counted from the time of enrollment until a participant started the post-surgery course of pembrolizumab. Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04. Adverse events and deaths in this arm are only counted after a participant started the post-surgery course of pembrolizumab. Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04. Adverse events in this arm are only counted until 30 days after RCC resection for non-serious adverse events, 90 days for serious adverse events, or until a participant started the post-surgery course of pembrolizumab, whichever occurred first. Deaths are counted from the time of enrollment until a participant started the post-surgery course of pembrolizumab. Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04. Adverse events and deaths in this arm are only counted after a participant started the post-surgery course of pembrolizumab.
All-Cause Mortality
Neoadjuvant Pembrolizumab + RCC Resection Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab SOC RCC Resection RCC Resection + Post-Resection Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/1 (0.00%)      1/4 (25.00%)      0/1 (0.00%)    
Hide Serious Adverse Events
Neoadjuvant Pembrolizumab + RCC Resection Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab SOC RCC Resection RCC Resection + Post-Resection Pembrolizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      1/1 (100.00%)      0/3 (0.00%)      0/1 (0.00%)    
Infections and infestations         
Infections and infestations  1 [1]  1/4 (25.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Metabolism and nutrition disorders         
Metabolism and nutrition disorders  1 [1]  0/4 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
[1]
Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neoadjuvant Pembrolizumab + RCC Resection Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab SOC RCC Resection RCC Resection + Post-Resection Pembrolizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      1/1 (100.00%)      0/3 (0.00%)      1/1 (100.00%)    
Eye disorders         
Eye disorders  1 [1]  1/4 (25.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
General disorders         
General disorders and administration site conditions  1 [1]  1/4 (25.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
General disorders and administration site conditions  1 [1]  1/4 (25.00%)  2 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
General disorders and administration site conditions  1 [1]  0/4 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
General disorders and administration site conditions  1 [1]  0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Investigations         
Investigations  1 [1]  0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Investigations  1 [1]  1/4 (25.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Metabolism and nutrition disorders         
Metabolism and nutrition disorders  1 [1]  0/4 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Musculoskeletal and connective tissue disorders  1 [1]  0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Musculoskeletal and connective tissue disorders  1 [1]  1/4 (25.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders         
Nervous system disorders  1 [1]  1/4 (25.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders         
Skin and subcutaneous tissue disorders  1 [1]  0/4 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders  1 [1]  1/4 (25.00%)  1 1/1 (100.00%)  3 0/3 (0.00%)  0 1/1 (100.00%)  1
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
[1]
Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns.
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.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02212730    
Other Study ID Numbers: 3475-031
2014-002526-12 ( EudraCT Number )
MK-3475-031 ( Other Identifier: Merck )
KEYNOTE-031 ( Other Identifier: Merck )
First Submitted: August 6, 2014
First Posted: August 8, 2014
Results First Submitted: June 22, 2020
Results First Posted: July 16, 2020
Last Update Posted: July 16, 2020