Trial Outcomes & Findings for A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031) (NCT NCT02212730)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

Up to Week 16

Results posted on

2020-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Neoadjuvant Pembrolizumab + RCC Resection 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.	RCC Resection 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 Study STARTED	6	4
Overall Study Received Neoadjuvant Pembrolizumab	4	0
Overall Study Underwent RCC	4	3
Overall Study Received Post-RCC Pembrolizumab	1	1
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Neoadjuvant Pembrolizumab + RCC Resection 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.	RCC Resection 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 Study Tumor not of the required cell histology	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Disease progression prior to RCC surgery	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neoadjuvant Pembrolizumab + RCC Resection n=6 Participants 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.	RCC Resection n=4 Participants 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 n=10 Participants Total of all reporting groups
Age, Continuous	66.5 Years STANDARD_DEVIATION 5.2 • n=5 Participants	55.3 Years STANDARD_DEVIATION 9.1 • n=7 Participants	62.0 Years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 16

Population: Per protocol, the analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab.

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.

Outcome measures

Outcome measures
Measure	Neoadjuvant Pembrolizumab + RCC Resection n=4 Participants 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.	RCC Resection 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.
Number of Participants With an Adverse Event (AE) During the Neoadjuvant Pembrolizumab Regimen	4 Participants	—

PRIMARY outcome

Timeframe: Up to 56 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Neoadjuvant Pembrolizumab + RCC Resection n=4 Participants 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.	RCC Resection n=1 Participants 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.
Number of Participants Who Discontinued Treatment Due to an Adverse Event During neoadjuvant pembrolizumab	0 Participants	0 Participants
Number of Participants Who Discontinued Treatment Due to an Adverse Event During post-RCC resection pembrolizumab	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline and Week 7

Population: The analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab and whose samples were evaluable.

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.

Outcome measures

Outcome measures
Measure	Neoadjuvant Pembrolizumab + RCC Resection n=4 Participants 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.	RCC Resection 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.
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD3+ Lymphocytic Infiltration	1 Participants	—

PRIMARY outcome

Timeframe: Baseline and Week 7

Population: The analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab and whose samples were evaluable.

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.

Outcome measures

Outcome measures
Measure	Neoadjuvant Pembrolizumab + RCC Resection n=4 Participants 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.	RCC Resection 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.
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD8+ Lymphocytic Infiltration	1 Participants	—

PRIMARY outcome

Timeframe: Baseline and Week 7

Population: The analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab and whose samples were evaluable.

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.

Outcome measures

Outcome measures
Measure	Neoadjuvant Pembrolizumab + RCC Resection n=3 Participants 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.	RCC Resection 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.
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral FoxP3+ Lymphocytic Infiltration	0 Participants	—

Adverse Events

Neoadjuvant Pembrolizumab + RCC Resection

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

SOC RCC Resection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

RCC Resection + Post-Resection Pembrolizumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neoadjuvant Pembrolizumab + RCC Resection n=4 participants at risk 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.	Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab n=1 participants at risk 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.	SOC RCC Resection n=3 participants at risk 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.	RCC Resection + Post-Resection Pembrolizumab n=1 participants at risk 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.
Infections and infestations Infections and infestations	25.0% 1/4 • Number of events 1 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.	0.00% 0/3 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.00% 0/4 • Up to 77 weeks 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.	100.0% 1/1 • Number of events 1 • Up to 77 weeks 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.	0.00% 0/3 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.

Other adverse events

Other adverse events
Measure	Neoadjuvant Pembrolizumab + RCC Resection n=4 participants at risk 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.	Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab n=1 participants at risk 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.	SOC RCC Resection n=3 participants at risk 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.	RCC Resection + Post-Resection Pembrolizumab n=1 participants at risk 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.
Eye disorders Eye disorders	25.0% 1/4 • Number of events 1 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.	0.00% 0/3 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.
General disorders General disorders and administration site conditions	0.00% 0/4 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.	0.00% 0/3 • Up to 77 weeks 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.	100.0% 1/1 • Number of events 1 • Up to 77 weeks 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.
Investigations Investigations	25.0% 1/4 • Number of events 1 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.	0.00% 0/3 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.00% 0/4 • Up to 77 weeks 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.	100.0% 1/1 • Number of events 1 • Up to 77 weeks 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.	0.00% 0/3 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	25.0% 1/4 • Number of events 1 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.	0.00% 0/3 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.
Nervous system disorders Nervous system disorders	25.0% 1/4 • Number of events 1 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.	0.00% 0/3 • Up to 77 weeks 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.	0.00% 0/1 • Up to 77 weeks 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.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	25.0% 1/4 • Number of events 1 • Up to 77 weeks 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.	100.0% 1/1 • Number of events 3 • Up to 77 weeks 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.	0.00% 0/3 • Up to 77 weeks 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.	100.0% 1/1 • Number of events 1 • Up to 77 weeks 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.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER