The trial is taking place at:
C

Clinica Universidad de Navarra | Sede Madrid - Hematology Department

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A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer (RELATIVITY-106)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Carcinoma, Hepatocellular

Treatments

Drug: Relatlimab
Drug: Bevacizumab
Other: Placebo
Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05337137
CA224-106
U1111-1267-1579 (Other Identifier)
2021-003606-53 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

162 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

162 participants in 2 patient groups

Arm A: Relatlimab + Nivolumab + Bevacizumab
Experimental group
Treatment:
Drug: Nivolumab
Drug: Bevacizumab
Drug: Relatlimab
Arm B: Placebo + Nivolumab + Bevacizumab
Experimental group
Treatment:
Drug: Nivolumab
Other: Placebo
Drug: Bevacizumab

Trial contacts and locations

64

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Central trial contact

First line of the email MUST contain NCT # and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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