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

Phase 3

Active, not recruiting

• Conditions: Hepatocellular Carcinoma; Liver Cancer

• Registration Number: NCT03383458
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-26
• Study Start: 2018-04-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-04-28
• Study Completion: 2025-12-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 545

Inclusion Criteria

• Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
• Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
• Child-Pugh Score 5 or 6
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• Any evidence of tumor metastasis or co-existing malignant disease
• Participants previously receiving any prior therapy for HCC, including loco-regional therapies
• Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
• Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella [MMR]).

Other protocol defined inclusion/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence-free Survival (RFS)	Up to 49 months

Secondary Outcome Measures

Name	Time	Method
Time to recurrence (TTR)	Up to 49 months
Overall Survival (OS)	Up to 7 years

Trial Locations

Locations (175)

Local Institution - 0081; 🇺🇸 Anniston, Alabama, United States

Mayo Clinic in Arizona - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Arizona Oncology Associates, PC - HOPE; 🇺🇸 Tucson, Arizona, United States

Local Institution - 0135; 🇺🇸 Los Angeles, California, United States

Local Institution - 0088; 🇺🇸 Palo Alto, California, United States

Local Institution - 0085; 🇺🇸 San Francisco, California, United States

Local Institution - 0235; 🇺🇸 Aurora, Colorado, United States

Miami VA Healthcare System; 🇺🇸 Miami, Florida, United States

Sylvester Comprehensive Cancer Center/ UMHC; 🇺🇸 Miami, Florida, United States

Local Institution - 0163; 🇺🇸 Tampa, Florida, United States

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