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Opdualag

(Relatlimab)

Phase 3Monoclonal antibody

Bristol-Myers Squibb

Relatlimab is used to treat a type of skin cancer called melanoma. It works by boosting the immune system to help the body fight cancer cells.[1] Opdualag is currently being investigated across 11 indications[3], with its most advanced program in Phase 3.[1]

Opdualag is one of 213 biologic programs targeting Basal Cell Carcinoma. It is currently in Phase 3.

11

Indications

54

Total Trials

27

Active Trials

212

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Basal Cell CarcinomaRecruiting

Esophageal CancerActive, not recruiting

Metastatic MelanomaRecruiting

Non-Small Cell Lung CancerActive, not recruiting

MelanomaActive, not recruiting

Gastric CancerCompleted

Urologic NeoplasmsActive, not recruiting

High Grade GliomaNot yet recruiting

Melanoma (skin)Recruiting

AzacytidineRecruiting

Basal Cell CarcinomaPhase 2

Recruiting

Esophageal CancerPhase 1

Active, not recruiting

Metastatic MelanomaPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

MelanomaPhase 3

Active, not recruiting

Gastric CancerPhase 2

Completed

Urologic NeoplasmsPhase 2

Active, not recruiting

High Grade GliomaPhase 2

Not yet recruiting

Melanoma (skin)Phase 2

Recruiting

AzacytidinePhase 2

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Yervoy

Bristol-Myers Squibb

Cyramza

Opdualag

Bristol-Myers Squibb

Apatinib

LLaNova Medicines Zhejiang Co., Ltd.

Remeron

OOrganon and Co

Treatment

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

PD-1 Inhibitors

BBioNTech US Inc.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Gastric Cancer

NCT03610711

Phase 2Active, not recruiting

Locally Advanced Bladder Urothelial Carcinoma

NCT04953104

Q3 2027

Phase 2Active, not recruiting

Carcinomas

NCT05347212

Phase 1Active, not recruiting

Esophageal Cancer

NCT03044613

Q4 2027

Phase 2Active, not recruiting

Solid Tumor

NCT03607890

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Clinical

Trials by Indication[1]

Melanoma4 trials

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2/3·NCT03470922·714 enrolled

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

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03978611·11 enrolled

A Phase II Study of Anti-PD1 Monoclonal Antibody (Nivolumab, BMS-936558) Administered in Combination With Anti-LAG3 Monoclonal Antibody (Relatlimab, BMS-986016) in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting

Completed·JJohn Kirkwood·Phase 2·NCT03743766·43 enrolled

Show 1 more trial

Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY)

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06683755·30 enrolled

Metastatic Melanoma4 trials

Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression

Terminated·EElizabeth Davis·Phase 2·NCT03724968·2 enrolled

Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma

Recruiting·JJohn Kirkwood··NCT07223411·20 enrolled

A Phase II Study of PD-1 Blockade With or Without LAG-3 Inhibition in Combination With Infliximab for the Treatment of Metastatic Melanoma and Prevention of Adverse Events

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT05034536·36 enrolled

Show 1 more trial

A Multi-center Trial Evaluating the ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab for Advanced Melanoma

Recruiting·NNYU Langone Health·Phase 2·NCT07504796·90 enrolled

Non-Small Cell Lung Cancer3 trials

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)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT04623775·468 enrolled

An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02750514·295 enrolled

A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06561386·1,000 enrolled

Immunotherapy2 trials

An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT03459222·229 enrolled

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

Unknown status·UUniversity Hospital, Essen·Phase 2·NCT04062656·21 enrolled

Gastric Cancer2 trials

REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT03610711·21 enrolled

A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02935634·190 enrolled

38 more indications

Nivolumab2 trials

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04112498·24 enrolled

Study of Relatlimab in Combination With Nivolumab in Chinese Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05498480·6 enrolled

Chordoma1 trial

Nivolumab and Relatlimab in Treating Participants With Advanced Chordoma

Completed·JJonsson Comprehensive Cancer Center·Phase 2·NCT03623854·10 enrolled

ESS1 trial

Expanded Access for Relatlimab

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT05170659

Esophageal Cancer1 trial

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

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT03044613·32 enrolled

Relapsed/Refractory B-cell Malignancies1 trial

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT03310619·62 enrolled

Patients With Advanced Solid Tumors1 trial

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02966548·35 enrolled

Uveal Melanoma1 trial

Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

Completed·—·Phase 2·NCT04552223·27 enrolled

Virus-associated Tumors1 trial

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT02488759·578 enrolled

Neoadjuvant1 trial

Neoadjuvant and Adjuvant Checkpoint Blockade

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02519322·53 enrolled

Azacytidine1 trial

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

Recruiting·LLudwig-Maximilians - University of Munich·Phase 2·NCT04913922·30 enrolled

Colorectal Cancer1 trial

Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03642067·59 enrolled

Patients With Solid Tumors1 trial

An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03335540·20 enrolled

Mismatch Repair Deficiency1 trial

Testing Nivolumab and BMS-986016 (Relatlimab) as Potentially Targeting Treatment in Cancers That Are LAG-3+ and Have Mismatch Repair Deficiency (MATCH - Subprotocol Z1M)

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT06400264

Basal Cell Carcinoma1 trial

Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03521830·57 enrolled

Renal Cell Carcinoma1 trial

A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02996110·182 enrolled

Liver Cancer1 trial

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT04567615·266 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03704077

Ovarian Cancer1 trial

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

Terminated·IInge Marie Svane·Phase 1/2·NCT04611126·6 enrolled

Effectiveness1 trial

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT01968109·1,482 enrolled

Metastatic Nasopharyngeal Carcinoma1 trial

A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06029270·156 enrolled

Muscle Invasive Bladder Urothelial Carcinoma1 trial

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT05987241·992 enrolled

Glioblastoma Multiforme1 trial

Randomized Phase II Trial of Anti-Lag-3 and Anti-PD-1 Blockade vs. SOC in Patients With Recurrent Glioblastoma

Suspended·NNational Cancer Institute (NCI)·Phase 2·NCT06325683·184 enrolled

Hepatocellular Carcinoma1 trial

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

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT04658147·31 enrolled

Squamous Cell Carcinoma1 trial

A Phase II Study of Triplet Immunotherapy For Exhausted Cell Targets in Advanced Squamous Cell Carcinoma (TRIFECTA-SCC)

Not yet recruiting·MMedical College of Wisconsin·Phase 2·NCT07896811·26 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Carcinoma, Hepatocellular1 trial

A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Preclinical·NCT05337137·82 enrolled

Cutaneous Melanoma1 trial

Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High Risk Melanoma

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06319196·54 enrolled

Solid Tumor1 trial

Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03607890·38 enrolled

Carcinomas1 trial

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

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05347212·30 enrolled

Locally Advanced Bladder Urothelial Carcinoma1 trial

A Phase II Clinical Trial to Investigate ARID1A and/or KDM6A Mutation and CXCL13 Expression in the Pre-treatment Tumor Samples as a Combinatorial Predictive Biomarker for Immune Checkpoint Therapy in Metastatic Urothelial Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04953104·6 enrolled

Colon Carcinoma1 trial

Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer (Amended Protocol of: Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity: The NICHE TRIAL)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT03026140·353 enrolled

Newly Diagnosed Glioblastoma1 trial

A Multi-Center, Randomized, Phase 2 Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab (GIANT)

Recruiting·DDuke University·Phase 2·NCT06816927·92 enrolled

Head and Neck Squamous Cell Carcinoma (HNSCC)1 trial

A Phase II Neoadjuvant Study of the Safety and Tolerability of Anti-PD1 (Nivolumab) Administered Alone or in Combination With Anti-LAG3 (Relatlimab) or Anti-CTLA4 (Ipilimumab) in Resectable Head and Neck Cancer

Active, not recruiting·DDan Zandberg·Phase 2·NCT04080804·80 enrolled

High Grade Glioma1 trial

Feasibility and Phase 2a Study of Relatlimab and Nivolumab (Opdualag™) in Adolescent and Young Adult Patients Newly Diagnosed With Replication Repair Deficient High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG)

Not yet recruiting·NNationwide Children's Hospital·Phase 2·NCT07644312·12 enrolled

Melanoma (Skin)1 trial

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

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05704647·30 enrolled

Urologic Neoplasms1 trial

A Phase 2 Trial in Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab

Active, not recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT06237920·90 enrolled

Lymphoma, Non-Hodgkin1 trial

A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Preclinical·NCT05255601·5 enrolled

Unspecified1 trial

Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03899155·1,500 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 18, 2022

OPDUALAG

NDA BLA761234

Mar 6, 2024

OPDUALAG

NDA BLA761234

Jun 8, 2026

OPDUALAG

NDA BLA761234

Sources

References

[1]
ClinicalTrials.gov — 54 trial records for Relatlimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Relatlimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Relatlimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA761234). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Lymphocyte Activation Gene 3 Protein Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Bristol-Myers Squibb

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