A Study of Relatlimab in Combination with Nivolumab in Participants with Advanced Liver Cancer who have never been been Treated with Immuno-oncology Therapy after Prior Treatment with Tyrosine Kinase Inhibitors

Phase 1

• Conditions: Advanced Hepatocellular Carcinoma; MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10077738Term: Hepatocellular carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003151-38-CZ
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-03
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

- Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation
- Must have advanced/metastatic HCC
- Have to be immunotherapy treatment-naive; no prior immunotherapies are permitted
- Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion
- Child-Pugh score of 5 or 6
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 142

Exclusion Criteria

- Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma
- Prior organ allograft or allogeneic bone marrow transplantation
- No uncontrolled or significant cardiovascular disease
- No active known autoimmune disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of relatlimab in combination with nivolumab relative to nivolumab monotherapy in IO therapy-naive participants after prior treatment with TKI therapy;Secondary Objective: - To investigate safety and tolerability of relatlimab in combination with nivolumab in participants with advanced HCC<br>- To further evaluate the preliminary efficacy of relatlimab in combination with nivolumab<br>- To characterize the dose-response relationship of relatlimab in combination with nivolumab<br>- To assess the association of LAG-3 expression by IHC with clinical response;Primary end point(s): Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;Timepoint(s) of evaluation of this end point: Up to 2 years after first dose of treatment