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NCT03867084 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 959
- Enrollment target
NCT03867084: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03867084 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 959 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03867084, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 959 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).
Primary Outcome
RFS was defined as the time from randomization to first documentation of disease recurrence (local, regional, or distant) as assessed by blinded independent central review (BICR) or by pathology consistent with HCC if required per the site's standard of care, or death due to any cause (both cancer and non-cancer causes of death), whichever occurred first. RFS was reported for each arm.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 959 participants |
| Start Date | 2019-05-28 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 3 |
What the finished NCT03867084 record still lists
NCT03867084 is an interventional study that assigns participants to a tested intervention. The registered 959 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 (24% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03867084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03867084 about?
NCT03867084 is a clinical study titled "Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)". This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pem...
What is the current status of trial NCT03867084?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 959 participants. The study started on 2019-05-28. Estimated completion is 2025-09-30.
What interventions are being tested in trial NCT03867084?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG).
Who is sponsoring clinical trial NCT03867084?
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 NCT03867084's enrollment target sits among peer trials
959 332nd of 2000 higher than 1,669 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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