Description:
The purpose of this study is to compare effectiveness and safety of nivolumab with and
without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone
in participants with intermediate liver cancer
Title
- Brief Title: A Study of Nivolumab and Ipilimumab in Combination With Transarterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
- Official Title: A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)
Clinical Trial IDs
- ORG STUDY ID:
CA209-74W
- NCT ID:
NCT04340193
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| nivolumab | | Nivolumab + Ipilimumab + TACE |
| ipilimumab | | Nivolumab + Ipilimumab + TACE |
Purpose
The purpose of this study is to compare effectiveness and safety of nivolumab with and
without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone
in participants with intermediate liver cancer
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Nivolumab + Ipilimumab + TACE | Experimental | TACE (Trans-arterial Chemoembolization) | |
| Nivolumab + Ipilimumab Placebo + TACE | Experimental | TACE (Trans-arterial Chemoembolization) | |
| Nivolumab Placebo + Ipilimumab Placebo + TACE | Placebo Comparator | TACE (Trans-arterial Chemoembolization) | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Participant has intermediate-stage HCC (hepatocellular carcinoma) whose tumor
characteristics exceed the BMU7 criteria and is eligible for TACE
- Participant has histologic confirmation of HCC
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Men and Women must agree to follow methods of contraception
- Participants are eligible to enroll if they have non-viral related HCC, or if they
have HBV-HCC, or HCV-HCC
Exclusion Criteria:
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior liver transplant or participants who are on the waiting list for liver
transplantation
- Active, known, or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids
or other immunosuppressive medications
- Any previous TACE or TAE (trans-arterial embolization without instillation of
chemotherapy agent) procedure for HCC
- Known or suspected allergy to nivolumab, ipilimumab, or study drug components given in
association with this trial
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: | Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm A versus Arm C |
| Time Frame: | up to 2 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm B versus Arm C |
| Time Frame: | up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Overall Survival (OS): Arm B versus Arm C |
| Time Frame: | up to 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Event-Free Survival (EFS) |
| Time Frame: | up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression-free survival (PFS) |
| Time Frame: | up to 2 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 25, 2021
