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NCT03383458Phase 3ACTIVE NOT RECRUITING

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Study Summary

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

Conditions
Hepatocellular CarcinomaLiver Cancer
Interventions / Drugs
NivolumabPlacebo
View on ClinicalTrials.gov ↗
Sponsor
BMY
Bristol-Myers Squibb
Oncology
F27/100
Study Details
Enrollment545 participants
Primary Completion—
Lead SponsorBristol-Myers Squibb
Data Retrieved2026-04-11 04:08:14.745476+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 545 participants
Sponsor Catalyst Profile

Bristol-Myers Squibb (BMY) is the sponsoring company for this trial. BiotechSign currently grades this company F (27/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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