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Completed

NCT Number: NCT05337137

A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer

The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0045, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC)
  • Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team)
  • Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria

  • Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
  • Prior allogenic stem cell or solid organ transplantation
  • Untreated symptomatic central nervous system (CNS) metastases
  • Clinically significant ascites as defined by:

i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Relatlimab

Drug

Specified dose on specified days

Other names: BMS-986016

Nivolumab

Drug

Specified dose on specified days

Other names: BMS-936558, Opdivo

Bevacizumab

Drug

Specified dose on specified days

Other names: Avastin

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Incidence of dose-limiting toxicities (DLTs)

    Time frame: Up to 6 weeks

  2. Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Assessed up to 3 years

Secondary outcomes

  1. Progression Free Survival (PFS) by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive

    Time frame: Assessed up to 3 years

  2. PFS by BICR per RECIST v1.1 in all randomized participants

    Time frame: Assessed up to 3 years

  3. ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive

    Time frame: Assessed up to 3 years

  4. Overall Survival (OS) of all randomized participants

    Time frame: Assessed up to 3 years

  5. OS of all randomized participants that are LAG-3 positive

    Time frame: Assessed up to 3 years

  6. Number of participants with adverse events (AEs)

    Time frame: Up to 135 days after participant's last dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma

Acronym: RELATIVITY-106

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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