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
Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab
- Conditions
- Newly Diagnosed Glioblastoma
- Interventions
- First Posted Date
- 2025-02-10
- Last Posted Date
- 2025-02-10
- Lead Sponsor
- Duke University
- Target Recruit Count
- 92
- Registration Number
- NCT06816927
- Locations
- 🇺🇸
Duke University, Durham, North Carolina, United States
Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY)
- Conditions
- Melanoma
- Interventions
- First Posted Date
- 2024-11-11
- Last Posted Date
- 2024-11-11
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 30
- Registration Number
- NCT06683755
- Locations
- 🇺🇸
The University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States
Neoadjuvant Opdualag Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
- First Posted Date
- 2024-10-03
- Last Posted Date
- 2025-03-14
- Lead Sponsor
- University of California, San Diego
- Target Recruit Count
- 30
- Registration Number
- NCT06624475
- Locations
- 🇺🇸
University of California, San Diego Moores Cancer Center, La Jolla, California, United States
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- First Posted Date
- 2024-08-20
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 1000
- Registration Number
- NCT06561386
- Locations
- 🇮🇹
Local Institution - 0222, Ravenna, Italy
🇺🇸Local Institution - 0368, Tucson, Arizona, United States
🇺🇸Local Institution - 0112, Los Angeles, California, United States
Anti-Lag-3 (Relatlinib) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma
- Conditions
- Recurrent Glioblastoma
- Interventions
- Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Magnetic Resonance ImagingProcedure: Surgical Procedure
- First Posted Date
- 2024-03-22
- Last Posted Date
- 2025-04-09
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 184
- Registration Number
- NCT06325683
- Locations
- 🇺🇸
MaineHealth Cancer Care and IV Therapy - South Portland, South Portland, Maine, United States
🇺🇸Sutter Auburn Faith Hospital, Auburn, California, United States
🇺🇸Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma
- Conditions
- Melanoma Stage IVCutaneous MelanomaMucosal Melanoma
- Interventions
- First Posted Date
- 2024-03-19
- Last Posted Date
- 2025-03-03
- Lead Sponsor
- University Health Network, Toronto
- Target Recruit Count
- 54
- Registration Number
- NCT06319196
- Locations
- 🇨🇦
UHN- Princess Margaret Cancer Center, Toronto, Ontario, Canada
Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab
- Conditions
- Urinary Bladder DiseasesUrinary Bladder NeoplasmAntineoplastics ToxicityUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsNeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesNeoplasms by Site
- Interventions
- First Posted Date
- 2024-02-02
- Last Posted Date
- 2025-03-06
- Lead Sponsor
- The Netherlands Cancer Institute
- Target Recruit Count
- 90
- Registration Number
- NCT06237920
- Locations
- 🇳🇱
NKI-AVL, Amsterdam, Noord-Holland, Netherlands
🇳🇱Radboud University Medical Center, Nijmegen, Gelderland, Netherlands
🇳🇱Amsterdam UMC (AUMC), Amsterdam, Noord-Holland, Netherlands
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
- Conditions
- Metastatic Nasopharyngeal CarcinomaRecurrent Nasopharyngeal CarcinomaStage IV Nasopharyngeal Carcinoma AJCC v8
- Interventions
- Procedure: Bone ScanProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography
- First Posted Date
- 2023-09-08
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 156
- Registration Number
- NCT06029270
- Locations
- 🇺🇸
Bozeman Health Deaconess Hospital, Bozeman, Montana, United States
🇺🇸Benefis Sletten Cancer Institute, Great Falls, Montana, United States
🇺🇸Logan Health Medical Center, Kalispell, Montana, United States
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study
- Conditions
- Stage II Bladder Urothelial Carcinoma AJCC v6 and v7Stage IV Bladder Urothelial Carcinoma AJCC v7Muscle Invasive Bladder Urothelial CarcinomaStage III Bladder Urothelial Carcinoma AJCC v6 and v7
- Interventions
- Procedure: Biospecimen CollectionProcedure: Computed TomographyOther: cfDNA or ctDNA MeasurementProcedure: Magnetic Resonance ImagingOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- First Posted Date
- 2023-08-14
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 1190
- Registration Number
- NCT05987241
- Locations
- 🇺🇸
Cancer Center at Saint Joseph's, Phoenix, Arizona, United States
🇺🇸University of Arizona Cancer Center-Orange Grove Campus, Tucson, Arizona, United States
🇺🇸Banner University Medical Center - Tucson, Tucson, Arizona, United States
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
- Conditions
- CancerMelanoma Stage IIIMelanoma Stage IVCutaneous Melanoma
- Interventions
- First Posted Date
- 2023-08-01
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- Krystal Biotech, Inc.
- Target Recruit Count
- 240
- Registration Number
- NCT05970497
- Locations
- 🇺🇸
UCLA Health, Los Angeles, California, United States
🇺🇸Mission Dermatology Center, Rancho Santa Margarita, California, United States
🇺🇸BRCR Global, Weston, Florida, United States
Drug Development Updates
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