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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05337137
Recruitment Status : Recruiting
First Posted : April 20, 2022
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Relatlimab Drug: Nivolumab Drug: Bevacizumab Other: Placebo Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 5, 2022
Estimated Primary Completion Date : June 4, 2024
Estimated Study Completion Date : December 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Relatlimab + Nivolumab + Bevacizumab Drug: Relatlimab
Specified dose on specified days
Other Name: BMS-986016

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Drug: Bevacizumab
Specified dose on specified days
Other Name: Avastin
Experimental: Arm B: Placebo + Nivolumab + Bevacizumab Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Drug: Bevacizumab
Specified dose on specified days
Other Name: Avastin

Other: Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05337137


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05337137    
Other Study ID Numbers: CA224-106
2021-003606-53 ( EudraCT Number )
U1111-1267-1579 ( Other Identifier: WHO )
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: May 10, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Hepatocellular Carcinoma
HCC
Liver Cancer
Relatlimab
 Nivolumab
Bevacizumab
First line HCC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Bevacizumab
 Nivolumab
Relatlimab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action