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NCT03142334 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 994
- Enrollment target
NCT03142334: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03142334 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 994 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03142334, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 994 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.
Primary Outcome
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) participa
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 994 participants |
| Start Date | 2017-06-09 |
| Est. Completion | 2026-02-04 |
| Phase | Phase 3 |
What the finished NCT03142334 record still lists
NCT03142334 is an interventional study that assigns participants to a tested intervention. The registered 994 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03142334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03142334 about?
NCT03142334 is a clinical study titled "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)". The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell comp...
What is the current status of trial NCT03142334?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 994 participants. The study started on 2017-06-09. Estimated completion is 2026-02-04.
What interventions are being tested in trial NCT03142334?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG).
Who is sponsoring clinical trial NCT03142334?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03142334's enrollment target sits among peer trials
994 313th of 2000 higher than 1,687 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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