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 ≥12 years old with unresectable or metastatic melanoma.

Associated Conditions
Metastatic Melanoma, Unresectable Melanoma

A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies

Phase 1
Completed
Conditions
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Interventions
First Posted Date
2017-10-16
Last Posted Date
2024-04-04
Lead Sponsor
Celgene
Target Recruit Count
62
Registration Number
NCT03310619
Locations
🇺🇸

Local Institution - 015, Omaha, Nebraska, United States

🇺🇸

Local Institution - 016, Philadelphia, Pennsylvania, United States

🇺🇸

Local Institution - 011, Duarte, California, United States

and more 6 locations

Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer

Phase 1
Active, not recruiting
Conditions
Gastric Cancer
Esophageal Cancer
GastroEsophageal Cancer
Interventions
First Posted Date
2017-02-07
Last Posted Date
2025-03-06
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
32
Registration Number
NCT03044613
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Alleghany Health Network, Pittsburgh, Pennsylvania, United States

🇺🇸

Baylor University/ Charles A. Sammons Cancer Center, Dallas, Texas, United States

Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer

First Posted Date
2017-01-20
Last Posted Date
2024-04-18
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
268
Registration Number
NCT03026140
Locations
🇳🇱

Marieke van de Belt, Amsterdam, Netherlands

🇳🇱

Catharina Ziekenhuis, Eindhoven, Netherlands

🇳🇱

Spaarne Ziekenhuis, Haarlem, Netherlands

and more 3 locations

Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors

Phase 1
Completed
Conditions
Cancer
Interventions
First Posted Date
2016-11-17
Last Posted Date
2025-02-17
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
35
Registration Number
NCT02966548
Locations
🇯🇵

Local Institution - 0001, Kashiwa-shi, Chiba, Japan

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors

Phase 1
Completed
Conditions
Various Advanced Cancer
Interventions
First Posted Date
2015-07-02
Last Posted Date
2023-11-13
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
578
Registration Number
NCT02488759
Locations
🇺🇸

Local Institution - 0003, Atlanta, Georgia, United States

🇧🇪

Local Institution - 0012, Brussels, Belgium

🇺🇸

Local Institution - 0033, Tampa, Florida, United States

and more 37 locations

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Phase 2
Active, not recruiting
Conditions
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Bladder Carcinoma
Breast Carcinoma
Cervical Carcinoma
Colon Carcinoma
Colorectal Carcinoma
Endometrial Carcinoma
Esophageal Carcinoma
Exocrine Pancreas Carcinoma
Interventions
First Posted Date
2015-06-08
Last Posted Date
2025-05-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
6452
Registration Number
NCT02465060
Locations
🇺🇸

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

🇺🇸

Thomas Hospital, Fairhope, Alabama, United States

🇺🇸

Mobile Infirmary Medical Center, Mobile, Alabama, United States

and more 1406 locations

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

Phase 2
Completed
Conditions
Microsatellite Stable Colorectal Cancer
Mismatch Repair Proficient Colorectal Cancer
Microsatellite Unstable Colorectal Cancer
Mismatch Repair Deficient Colorectal Cancer
Interventions
First Posted Date
2014-02-11
Last Posted Date
2024-11-19
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
385
Registration Number
NCT02060188
Locations
🇺🇸

Local Institution - 0028, Gilbert, Arizona, United States

🇺🇸

Local Institution - 0004, Los Angeles, California, United States

🇺🇸

Local Institution - 0036, Boston, Massachusetts, United States

and more 29 locations

An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Phase 1
Completed
Conditions
Neoplasms by Site
Interventions
First Posted Date
2013-10-23
Last Posted Date
2025-03-14
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
1499
Registration Number
NCT01968109
Locations
🇺🇸

Local Institution - 0002, Portland, Oregon, United States

🇯🇵

Local Institution - 0052, Chuo-ku, Tokyo, Japan

🇺🇸

Local Institution - 0043, La Jolla, California, United States

and more 51 locations
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