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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 959 participants.

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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).

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Placebo

Trial Details

FieldValue
Enrollment Target 959 participants
Start Date 2019-05-28
Est. Completion 2025-09-30
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT03867084

The ClinicalTrials.gov registry entry for NCT03867084 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 959 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.

NCT03867084 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.