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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 994 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03142334
The ClinicalTrials.gov registry entry for NCT03142334 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 994 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03142334 reports 0 study locations.
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.
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