Description:
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
Title
- Brief Title: A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
- Official Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Clinical Trial IDs
- ORG STUDY ID:
CA209-9DX
- NCT ID:
NCT03383458
Conditions
- Hepatocellular Carcinoma
- Liver Cancer
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo, BMS-936558 | Arm A |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | | |
Arm B | Placebo Comparator | | |
Eligibility Criteria
For more information regarding Bristol Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
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 could apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Recurrence-free Survival (RFS) |
Time Frame: | Up to 49 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Time to recurrence (TTR) |
Time Frame: | Up to 49 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
February 10, 2021