Phase 3
N=26
A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
Cancer, Hepatocellular
Bottom Line
View on ClinicalTrials.gov: NCT04340193 ↗Enrolled (actual)
26
Serious AEs
57.7%
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants With Adverse Events — 9; 9; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- nivolumab (Drug); ipilimumab (Drug); TACE (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
9; 9; 8 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
7; 6; 2 | — |
| PRIMARY Number of Participants Who Died |
2; 2; 0 | — |
| PRIMARY Number of Participants With Adverse Events Leading to Study Drug Discontinuation |
3; 1; 1 | — |
| PRIMARY Number of Participants With Worst Grade (Grade 3/4) Laboratory Results |
1; 0; 2; 2; 0; 0 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests |
5; 5; 5; 5; 4; 3 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests |
3; 2; 0; 2; 1; 0 | — |
Summary
The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.
Eligibility Criteria
Inclusion Criteria
- Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE)
- Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
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
Other protocol defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT04340193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.