MedPath

Relatlimab

Generic Name
Relatlimab
Brand Names
Opdualag
Drug Type
Biotech
CAS Number
1673516-98-7
Unique Ingredient Identifier
AF75XOF6W3
Background

Relatlimab is a human IgG4 monoclonal antibody and novel immune checkpoint inhibitor that targets lymphocyte activation gene-3 (LAG-3). It was the first commercially developed anti-LAG-3 antibody, entering clinical trials in 2013, and has garnered interest in the treatment of a variety of cancers, including leukemia and melanoma. As immune checkpoint inhibitors have limited efficacy when used alone, drugs like relatlimab have been trialed in combination with other checkpoint inhibitors - for example, PD-1 inhibitors like nivolumab or CTLA-4 inhibitors like ipilimumab - to enhance their efficacy.

Relatlimab received FDA approval in March 2022, alongside the PD-1 inhibitor nivolumab in the combination product Opdualag (Bristol-Myers Squibb), for the treatment of unresectable or metastatic melanoma. It was the first anti-LAG-3 antibody demonstrate benefit in a Phase 3 study, as well as the first to receive FDA approval.

Indication

Relatlimab is indicated in combination with nivolumab, in the combination product Opdualag, for the treatment of adult and pediatric patients โ‰ฅ12 years old with unresectable or metastatic melanoma.

Associated Conditions
Metastatic Melanoma, Unresectable Melanoma

Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases

Phase 2
Recruiting
Conditions
Melanoma (Skin)
Interventions
Drug: BMS-986213 (Relatlimab-Nivolumab FDC)
First Posted Date
2023-01-30
Last Posted Date
2025-04-23
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
30
Registration Number
NCT05704647
Locations
๐Ÿ‡บ๐Ÿ‡ธ

M D Anderson Cancer Center, Houston, Texas, United States

A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma

Phase 2
Recruiting
Conditions
Stage II Melanoma
Interventions
First Posted Date
2022-06-15
Last Posted Date
2025-01-07
Lead Sponsor
Melanoma Institute Australia
Target Recruit Count
20
Registration Number
NCT05418972
Locations
๐Ÿ‡ฆ๐Ÿ‡บ

Melanoma Institute Australia, Wollstonecraft, New South Wales, Australia

Phase II Trial of Immunotherapy in Patients With Carcinomas Arising From the Renal Medulla

Phase 2
Active, not recruiting
Conditions
Carcinomas
Renal Medullary Carcinoma
Interventions
First Posted Date
2022-04-26
Last Posted Date
2025-04-25
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
30
Registration Number
NCT05347212
Locations
๐Ÿ‡บ๐Ÿ‡ธ

MD Anderson Cancer Center, Houston, Texas, United States

A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer

Phase 1
Active, not recruiting
Conditions
Carcinoma, Hepatocellular
Interventions
First Posted Date
2022-04-20
Last Posted Date
2025-02-14
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
162
Registration Number
NCT05337137
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Local Institution - 0042, Los Angeles, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Local Institution - 0039, Los Angeles, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Local Institution - 0034, San Francisco, California, United States

and more 58 locations

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma

Phase 1
Recruiting
Conditions
Hodgkin Disease
Lymphoma, Non-Hodgkin
Interventions
First Posted Date
2022-02-24
Last Posted Date
2025-05-06
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
68
Registration Number
NCT05255601
Locations
๐Ÿ‡ฎ๐Ÿ‡น

Local Institution - 0013, Napoli, Italy

๐Ÿ‡ฎ๐Ÿ‡น

Fondazione MBBM - Clinica Pediatrica, Monza, Italy

๐Ÿ‡บ๐Ÿ‡ธ

Local Institution - 0017, Orlando, Florida, United States

and more 72 locations

Expanded Access for Relatlimab

First Posted Date
2021-12-28
Last Posted Date
2022-04-28
Lead Sponsor
Bristol-Myers Squibb
Registration Number
NCT05170659

Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer

Phase 2
Recruiting
Conditions
Renal Cell Carcinoma
Interventions
First Posted Date
2021-12-08
Last Posted Date
2022-05-09
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
69
Registration Number
NCT05148546
Locations
๐Ÿ‡ณ๐Ÿ‡ฑ

Netherlands Cancer Institute, Amsterdam, NH, Netherlands

๐Ÿ‡ฌ๐Ÿ‡ง

Royal Free London NHS Foundation Trust, London, United Kingdom

PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma

Phase 2
Recruiting
Conditions
Metastatic Melanoma
Interventions
First Posted Date
2021-09-05
Last Posted Date
2024-05-30
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
36
Registration Number
NCT05034536
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

ARID1A and/or KDM6A Mutation and CXCL13 Expression

Phase 2
Active, not recruiting
Conditions
Locally Advanced Urothelial Carcinoma
Locally Advanced Ureter Urothelial Carcinoma
Metastatic Renal Pelvis Urothelial Carcinoma
Recurrent Renal Pelvis Urothelial Carcinoma
Recurrent Ureter Urothelial Carcinoma
Stage IIIA Bladder Cancer AJCC v8
Unresectable Ureter Urothelial Carcinoma
Unresectable Urethral Urothelial Carcinoma
Unresectable Urothelial Carcinoma
Locally Advanced Bladder Urothelial Carcinoma
Interventions
Other: Diagnostic Laboratory Biomarker Analysis
First Posted Date
2021-07-07
Last Posted Date
2025-04-09
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
6
Registration Number
NCT04953104
Locations
๐Ÿ‡บ๐Ÿ‡ธ

M D Anderson Cancer Center, Houston, Texas, United States

Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML

Phase 2
Recruiting
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2021-06-04
Last Posted Date
2022-11-08
Lead Sponsor
Ludwig-Maximilians - University of Munich
Target Recruit Count
30
Registration Number
NCT04913922
Locations
๐Ÿ‡ฉ๐Ÿ‡ช

University Hospital, LMU Munich, Munich, Germany

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