Trial record 2 of 35 for:
relatlimab in combination with nivolumab
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 |
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Recruitment Status :
Recruiting
First Posted : September 28, 2020
Last Update Posted : November 14, 2022
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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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 |
| 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 : | April 30, 2024 |
| Estimated Study Completion Date : | October 31, 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 :
- 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 :
- Incidence of Adverse Events (AEs) [ Time Frame: Up to approximately 2.5 years ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2.5 years ]
- Incidence of AEs leading to discontinuation [ Time Frame: Up to approximately 2.5 years ]
- Incidence of death [ Time Frame: Up to approximately 2.5 years ]
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to approximately 2.5 years ]
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to approximately 2.5 years ]
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to approximately 2.5 years ]
- Disease control rate (DCR) assessed by BICR per RECIST v1.1 [ Time Frame: Up to 2 years until progression of disease ]
- Duration of response (DOR) assessed by BICR per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
- Progression-free survival assessed by BICR per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
- ORR assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
- DCR assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
- DOR assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
- PFS assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
- Overall survival (OS) [ Time Frame: Up to 3 years after first dose of treatment ]
Information from the National Library of Medicine
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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
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 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
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
- 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
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
| 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
Show 75 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| 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: | November 14, 2022 |
| Last Verified: | November 2022 |
| 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:
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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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Nivolumab 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 Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |