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Recruitment on holdLast updated: 8 December 2023

RELATIVITY-106: This phase I/II study is evaluating how safe and effective combining three targeted and immuno-therapies (nivolumab, relatilmab + bevacizumab) is, compared to the combination of two therapies (nivolumab + bevacizumab), in people with untreated, advanced or metastatic liver cancerA Phase 1/2, Safety Confirmation and Double-blind, Placebo-controlled, Randomized Study of Relatlimab in Combination With Nivolumab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Placebo Comparator Arm. In the Experimental Arm, participants will receive Relatlimab + Nivolumab + Bevacizumab. In the Placebo Comparator Arm, participants will receive Placebo + Nivolumab + Bevacizumab.

Conditions

This trial is treating patients with liver cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

I/II

Trial Acronym

RELATIVITY-106

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

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On hold hospitals

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