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Nivolumab-relatlimab FDC
This fixed-dose combination blocks both PD-1 and LAG-3 checkpoints on immune cells, releasing dual brakes on anti-tumor immunity.
This fixed-dose combination blocks both PD-1 and LAG-3 checkpoints on immune cells, releasing dual brakes on anti-tumor immunity. Used for Melanoma (advanced or metastatic), Non-small cell lung cancer.
At a glance
| Generic name | Nivolumab-relatlimab FDC |
|---|---|
| Also known as | BMS-986213 |
| Sponsor | Bristol-Myers Squibb |
| Drug class | Dual checkpoint inhibitor (PD-1/LAG-3) |
| Target | PD-1 and LAG-3 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Nivolumab is a PD-1 inhibitor that prevents tumor cells from suppressing T-cell activity via the PD-1/PD-L1 axis. Relatlimab is a LAG-3 inhibitor that blocks a second immune checkpoint, further enhancing T-cell activation and proliferation. Together, the combination provides dual checkpoint inhibition to overcome multiple immune evasion mechanisms used by tumors.
Approved indications
- Melanoma (advanced or metastatic)
- Non-small cell lung cancer
Common side effects
- Fatigue
- Diarrhea
- Rash
- Immune-mediated colitis
- Immune-mediated pneumonitis
- Hepatotoxicity
Key clinical trials
- Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) (PHASE2)
- Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (PHASE1, PHASE2)
- Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer (PHASE1)
- Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor (PHASE2)
- A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC) (PHASE2)
- VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3] (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nivolumab-relatlimab FDC CI brief — competitive landscape report
- Nivolumab-relatlimab FDC updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI