A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)

  • STATUS
    Recruiting
  • End date
    Oct 31, 2025
  • participants needed
    250
  • sponsor
    Bristol-Myers Squibb
Updated on 25 October 2022
cancer
tyrosine

Summary

The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.

Details
Condition Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult
Treatment Nivolumab, Relatlimab
Clinical Study IdentifierNCT04567615
SponsorBristol-Myers Squibb
Last Modified on25 October 2022

Eligibility

Yes No Not Sure

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 in the advanced/metastatic setting
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

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
Other protocol-defined inclusion/exclusion criteria apply
Have received one or two lines of tyrosine kinase inhibitor therapies
Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy
Clear my responses

How to participate?

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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