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A Study 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 Inhibitors

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ClinicalTrials.gov Identifier: NCT04567615
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Hepatoma Liver Cancer, Adult Liver Cell Carcinoma Liver Cell Carcinoma, Adult Biological: Nivolumab Biological: Relatlimab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : February 4, 2021
Estimated Primary Completion Date : June 27, 2024
Estimated Study Completion Date : July 21, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Arm A : Nivolumab Biological: Nivolumab
Specified dose on specified days
Other Name: OPDIVO, BMS-936558

Experimental: Arm B : Nivolumab + Relatlimab Dose 1 Biological: Nivolumab
Specified dose on specified days
Other Name: OPDIVO, BMS-936558

Biological: Relatlimab
Specified dose on specified days
Other Name: BMS-986016

Experimental: Arm C : Nivolumab + Relatlimab Dose 2 Biological: Nivolumab
Specified dose on specified days
Other Name: OPDIVO, BMS-936558

Biological: Relatlimab
Specified dose on specified days
Other Name: BMS-986016




Primary Outcome Measures :
  1. Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to approximately 2 years ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to approximately 2.5 years ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2.5 years ]
  3. Incidence of AEs leading to discontinuation [ Time Frame: Up to approximately 2.5 years ]
  4. Incidence of death [ Time Frame: Up to approximately 2.5 years ]
  5. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to approximately 2.5 years ]
  6. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to approximately 2.5 years ]
  7. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to approximately 2.5 years ]
  8. Disease control rate (DCR) assessed by BICR per RECIST v1.1 [ Time Frame: Up to 2 years until progression of disease ]
  9. Duration of response (DOR) assessed by BICR per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  10. Progression-free survival assessed by BICR per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  11. ORR assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  12. DCR assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  13. DOR assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  14. PFS assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  15. Overall survival (OS) [ Time Frame: Up to 3 years after first dose of treatment ]
  16. Dose: participant's actual dose as treated [ Time Frame: Up to 8 weeks ]
  17. Response: participant's best overall response (BOR) assessed by BICR using RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  18. LAG-3 expression by Immunohistochemistry (IHC): participant's actual LAG-3 expression value dichotomized into ≥ 1% and < 1% [ Time Frame: Up to 1 month ]
  19. Response: participant's BOR assessed by BICR using RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]


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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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Key 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; no prior immunotherapies are permitted
  • 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

Key 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


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): NCT04567615


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Show Show 68 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04567615    
Other Study ID Numbers: CA224-073
2018-003151-38 ( EudraCT Number )
U1111-1218-6499 ( Other Identifier: UTN Number )
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bristol-Myers Squibb:
Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma
Liver Cancer
Liver Cancer, Adult
Liver Cell Carcinoma
Liver Cell Carcinoma, Adult
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action