Trial · NCT03142334

Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)

NCT03142334, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2021-12-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564). Trials, record NCT03142334. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03142334

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)
NCT number: NCT03142334
Status: Completed
Phases: Phase 3
Enrollment: 994 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Renal Cell Carcinoma
Interventions: Pembrolizumab, Placebo
First posted: 2017-05-05
Last updated: 2026-03-10
Other registries' IDs: eudract:2016-004351-75
Results first posted: 2021-12-28

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease-free Survival (DFS) as Assessed by the Investigator	Up to approximately 42 months (database cutoff date 14 Dec 2020)	DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status (M0 versus M1 no evidence of disease (NED) by investigator) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 versus 1), United States (US) participant (Yes versus No) within M0 group by investigator was used to report hazard ratio (HR) and 95% confidence intervals (CIs).
Secondary	Overall Survival (OS)	Up to approximately 72 months	OS was defined as the time from randomization to death due to any cause.
Secondary	Number of Participants Who Experienced an Adverse Event (AE)	Nonserious AEs: Up to 30 days after last dose of study treatment (Up to approximately 13 months); Serious AEs: Up to 90 days after last dose of study treatment (Up to approximately 15 months)	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Participants are monitored for the occurrence of nonserious AEs for up to 30 days after last dose of study treatment and of serious AEs for up to 90 days after last dose of study treatment. The number of participants who experience an AE will be assessed.
Secondary	Number of Participants Who Discontinued Study Drug Due to an AE	Up to approximately 12 months	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinue study treatment due to an AE will be assessed.
Secondary	First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator	Up to approximately 72 months	DRSS1 is defined as the time from randomization to the first documented local recurrence of RCC as assessed by the investigator. For DRSS1, only local recurrence is counted as an event.
Secondary	Second Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator	Up to approximately 72 months	DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, as assessed by the investigator.
Secondary	Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR)	Up to approximately 72 months	EFS is defined as time from randomization to the first documented local recurrence or occurrence of distant kidney cancer metastasis(es) among participants which by BICR were considered disease-free at baseline (M0/M1 NED); or disease progression among participants which by BICR were considered to have baseline disease (M1), or death due to any cause, whichever occurs first.
Secondary	DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator	Up to approximately 72 months	DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. The PD-L1 expression status is based on combined positive score (CPS). If CPS is ≥ 1, PD-L1 expression status is positive and if the CPS is \<1, PD-L1 expression status is negative.
Secondary	OS According to Participant PD-L1 Expression Status (Positive, Negative)	Up to approximately 72 months	OS is defined as the time from randomization to death due to any cause. The PD-L1 expression status is based on combined positive score (CPS). If CPS is ≥ 1, PD-L1 expression status is positive and if the CPS is \<1, PD-L1 expression status is negative.
Secondary	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score	Baseline and Week 52	The QLQ-C30 quality of life (QOL) questionnaire contains 5 functioning scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain) and single symptom items (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Items are scored on a 4-point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much). The QLQC30 also contains 2 global health status scales that use 7-point scale scoring (1=very poor and 7=excellent). The change from baseline in the 2-item global health status/QOL life scale (range: 2-14) will be presented, with a higher score representing a higher QOL.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-free Survival (DFS) as Assessed by the Investigator	Up to approximately 42 months (database cutoff date 14 Dec 2020)	All randomized participants	Months	MEDIAN
SECONDARY	Overall Survival (OS)	Up to approximately 72 months
SECONDARY	Number of Participants Who Experienced an Adverse Event (AE)	Nonserious AEs: Up to 30 days after last dose of study treatment (Up to approximately 13 months); Serious AEs: Up to 90 days after last dose of study treatment (Up to approximately 15 months)
SECONDARY	Number of Participants Who Discontinued Study Drug Due to an AE	Up to approximately 12 months
SECONDARY	First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator	Up to approximately 72 months
SECONDARY	Second Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator	Up to approximately 72 months
SECONDARY	Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR)	Up to approximately 72 months
SECONDARY	DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator	Up to approximately 72 months
SECONDARY	OS According to Participant PD-L1 Expression Status (Positive, Negative)	Up to approximately 72 months
SECONDARY	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score	Baseline and Week 52

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Disease-free Survival (DFS) as Assessed by the Investigator	Pembrolizumab		NA	95% Confidence Interval NA to NA	Months
Disease-free Survival (DFS) as Assessed by the Investigator	Placebo		NA	95% Confidence Interval NA to NA	Months

Source ClinicalTrials.gov

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pembrolizumab	496
Overall Study	STARTED	Placebo	498
Overall Study	Treated	Pembrolizumab	488
Overall Study	Treated	Placebo	496
Overall Study	Continuing Study Treatment	Pembrolizumab	0
Overall Study	Continuing Study Treatment	Placebo	1
Overall Study	Completed Study Treatment	Pembrolizumab	298
Overall Study	Completed Study Treatment	Placebo	365
Overall Study	Discontinued Study Treatment	Pembrolizumab	190
Overall Study	Discontinued Study Treatment	Placebo	130

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events346

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hyperthyroidism	Endocrine disorders	Pembrolizumab	56	488	58
other	Hyperthyroidism	Endocrine disorders	Placebo	1	496	1
other	Hypothyroidism	Endocrine disorders	Pembrolizumab	103	488	111
other	Hypothyroidism	Endocrine disorders	Placebo	18	496	20
other	Abdominal pain	Gastrointestinal disorders	Pembrolizumab	36	488	54
other	Abdominal pain	Gastrointestinal disorders	Placebo	39	496	50
other	Constipation	Gastrointestinal disorders	Pembrolizumab	35	488	39
other	Constipation	Gastrointestinal disorders	Placebo	40	496	42
other	Diarrhoea	Gastrointestinal disorders	Pembrolizumab	123	488	195
other	Diarrhoea	Gastrointestinal disorders	Placebo	111	496	171

1 to 10 of 346Source ClinicalTrials.gov

See all 346 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pembrolizumab	18	496
Total, all-cause mortality	Placebo	33	498
Total, other adverse events	Pembrolizumab	436	488
Total, other adverse events	Placebo	393	496
Total, serious adverse events	Pembrolizumab	100	488
Total, serious adverse events	Placebo	56	496

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33526329	DERIVED	PubMed
34407342	DERIVED	PubMed
36055304	DERIVED	PubMed
37589219	DERIVED	PubMed
38631003	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pembrolizumab vs Placebo: deaths from any cause	Trial comparisons
Pembrolizumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03142334

GET https://conductscience.org/api/trials/v1/NCT03142334/events?page=2

API reference For AI assistants