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

Clinical Trials

Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)

Phase 1

Recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Nivolumab
Drug: Relatlimab

First Posted Date: 2020-12-08

Last Posted Date: 2025-01-10

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 20

Registration Number: NCT04658147

Locations: 🇺🇸
The Ohio State University, Wexner Medical Center, Columbus, Ohio, United States
🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Phase 2

Active, not recruiting

Conditions: Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Metastatic Non-small Cell Lung Cancer

Interventions: Biological: Nivolumab
Biological: Relatlimab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Cisplatin
Drug: Pemetrexed
Drug: Nab-Paclitaxel

First Posted Date: 2020-11-10

Last Posted Date: 2025-03-18

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 468

Registration Number: NCT04623775

Locations: 🇪🇸
Local Institution - 0048, Barcelona, Spain
🇪🇸
Local Institution - 0061, Las Palmas, Spain
🇪🇸
Local Institution - 0074, Madrid, Spain

and more 122 locations

T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer

Phase 1

Terminated

Conditions: Metastatic Ovarian Cancer
Metastatic Fallopian Tube Cancer
Peritoneal Cancer

Interventions: Drug: Cyclophosphamid
Drug: Ipilimumab
Drug: Fludarabine Phosphate
Biological: Tumor Infiltrating Lymphocytes infusion
Drug: Nivolumab
Drug: Relatlimab

First Posted Date: 2020-11-02

Last Posted Date: 2024-07-19

Lead Sponsor: Inge Marie Svane

Target Recruit Count: 5

Registration Number: NCT04611126

Locations: 🇩🇰
National Center for Cancer Immune Therapy (CCIT-DK), Herlev, Denmark

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

Phase 2

Active, not recruiting

Conditions: Hepatocellular Carcinoma
Hepatoma
Liver Cell Carcinoma, Adult
Liver Cell Carcinoma
Liver Cancer, Adult

Interventions: Biological: Nivolumab
Biological: Relatlimab

First Posted Date: 2020-09-28

Last Posted Date: 2025-03-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 266

Registration Number: NCT04567615

Locations: 🇧🇷
Local Institution - 0016, Barretos, SAO Paulo, Brazil
🇦🇷
Local Institution - 0010, Ciudad de Buenos Aires, Buenos Aires, Argentina
🇦🇷
Local Institution - 0019, Buenos Aires, Distrito Federal, Argentina

and more 62 locations

Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

Phase 2

Active, not recruiting

Conditions: Metastatic Uveal Melanoma

Interventions: Drug: Nivolumab
Drug: Relatlimab

First Posted Date: 2020-09-17

Last Posted Date: 2025-02-13

Lead Sponsor: Jose Lutzky, MD

Target Recruit Count: 27

Registration Number: NCT04552223

Locations: 🇺🇸
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients

Phase 2

Recruiting

Conditions: NSCLC Stage II
NSCLC, Stage IIIA
NSCLC, Stage I

Interventions: Drug: Nivolumab 10 MG/ML Intravenous Solution
Drug: Relatlimab 10 MG/ML Intravenous Solution

First Posted Date: 2019-12-19

Last Posted Date: 2024-05-09

Lead Sponsor: University Hospital, Essen

Target Recruit Count: 90

Registration Number: NCT04205552

Locations: 🇩🇪
Thoraxklinik Heidelberg gGmbH-Universitätsklinikum Heidelberg, Heidelberg, Germany
🇩🇪
University Hospital Essen, Essen, Germany
🇳🇱
Netherlands Cancer Institute, Amsterdam, Netherlands

and more 1 locations

A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab

Phase 1

Completed

Conditions: Cancer

Interventions: Drug: relatlimab
Drug: nivolumab
Drug: rHuPH20

First Posted Date: 2019-10-02

Last Posted Date: 2023-04-06

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 24

Registration Number: NCT04112498

Locations: 🇺🇸
Local Institution - 0001, Hackensack, New Jersey, United States

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions: Drug: Nivolumab
Drug: Relatlimab
Drug: Ipilimumab

First Posted Date: 2019-09-06

Last Posted Date: 2024-12-13

Lead Sponsor: Dan Zandberg

Target Recruit Count: 80

Registration Number: NCT04080804

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Perioperative Immunotherapy vs. Chemo-immunotherapy in Patients With Advanced GC and AEG

Phase 2

Active, not recruiting

Conditions: Gastric Cancer
Adenocarcinoma of the Esophagogastric Junction

Interventions: Drug: Nivolumab
Drug: Oxaliplatin
Drug: relatlimab
Drug: Docetaxel
Drug: 5-Fluorouracil (5-FU)
Drug: Folic acid (FA)

First Posted Date: 2019-08-20

Last Posted Date: 2024-03-12

Lead Sponsor: University Hospital, Essen

Target Recruit Count: 21

Registration Number: NCT04062656

Locations: 🇩🇪
University Hospital Essen, Essen, Germany
🇩🇪
Hämatologisch- Onkologische Praxis Eppendorf (HOPE), Hamburg, Germany
🇩🇪
Uniklinik Köln, Köln, Germany

A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment

Phase 1

Terminated

Conditions: Melanoma

Interventions: Drug: Relatlimab
Drug: Ipilimumab

First Posted Date: 2019-06-07

Last Posted Date: 2024-07-24

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 11

Registration Number: NCT03978611

Locations: 🇺🇸
Local Institution - 0002, Los Angeles, California, United States
🇧🇪
Local Institution - 0018, Bruxelles, Brussels, Belgium
🇧🇪
Local Institution - 0016, Brussels, Belgium

and more 25 locations

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