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    DRUG:

    Opdualag (nivolumab/relatlimab-rmbw)

    i
    Other names: BMS-986213, BMS-936558/BMS-986016, BMS986213, BMS 986213, BMS936558/BMS986016, BMS 936558/BMS 986016
    Company:
    BMS, Ono Pharmaceutical
    Drug class:
    PD1 inhibitor, LAG-3 inhibitor
    Related drugs:
    26d
    IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov)
    P2, N=225, Terminated, Iovance Biotherapeutics, Inc. | Trial completion date: Aug 2029 --> Feb 2026 | Recruiting --> Terminated | Trial primary completion date: Aug 2029 --> Feb 2026; After reviewing the available safety and efficacy data to date, Iovance concluded that the study reached the required number of events for evaluation of study endpoints.
    Trial completion date • Trial termination • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Keytruda (pembrolizumab) • cisplatin • Yervoy (ipilimumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • Opdualag (nivolumab/relatlimab-rmbw) • Amtagvi (lifileucel) • relatlimab (BMS-986016) • LN-145 • LN-145-S1
    2ms
    Efficacy of nivolumab plus relatlimab versus BRAF/MEK inhibitors for first-line treatment of BRAF-mutant advanced melanoma: A matching-adjusted indirect comparison. (PubMed, BMJ Oncol)
    In the absence of head-to-head trials comparing 1L nivolumab plus relatlimab (NIVO+RELA) to BRAF/MEK inhibitors, we compared its efficacy to dabrafenib+trametinib (DAB+TRAM), encorafenib+binimetinib (ENCO+BINI), vemurafenib+cobimetinib (VEM+COBI) and atezolizumab (ATEZO)+VEM+COBI using matching-adjusted indirect comparisons (MAICs)...These MAICs suggest that 1L dual IO therapy with NIVO+RELA confers a long-term OS advantage in BRAF-mutant advanced melanoma compared with BRAF/MEK inhibitor combinations despite lower ORR, consistent with prior evidence for 1L NIVO+IPI in this setting. As unanchored analyses, potential residual confounding remains, and results should be interpreted cautiously.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    RELA (RELA Proto-Oncogene)
    |
    BRAF mutation
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • Tafinlar (dabrafenib) • Cotellic (cobimetinib) • Mektovi (binimetinib) • Braftovi (encorafenib) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    3ms
    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) (clinicaltrials.gov)
    P2, N=260, Not yet recruiting, Bristol-Myers Squibb
    New P2 trial
    |
    MTAP (Methylthioadenosine Phosphorylase)
    |
    Opdivo (nivolumab) • carboplatin • gemcitabine • temozolomide • albumin-bound paclitaxel • pemetrexed • navlimetostat (BMS-986504) • Opdualag (nivolumab/relatlimab-rmbw) • daraxonrasib (RMC-6236) • pumitamig (BNT327)
    3ms
    A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unresectable or Metastatic Melanoma Participants In India (clinicaltrials.gov)
    P4, N=30, Not yet recruiting, Bristol-Myers Squibb
    New P4 trial
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
    3ms
    GlitIpNi: A phase IB clinical trial on neoadjuvant and intraoperative intracranial nadministration of triple immune checkpoint blockade plus myeloid dendritic ncells in patients with recurrent high-grade glioma (clinicaltrials.gov)
    P1, N=110, Active, not recruiting, Universitair Ziekenhuis Brussel | Phase classification: P1/2 --> P1
    Phase classification • Checkpoint inhibition
    |
    IDH wild-type
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw)
    4ms
    CA2360001: A Phase 1/2 Study of BMS-986482 Alone or Combination Therapy in Participants with Advanced Solid Tumors (2024-516602-28-00)
    P1/2, N=62, Recruiting, Bristol-Myers Squibb Services Unlimited Company
    New P1/2 trial
    |
    Avastin (bevacizumab) • Opdualag (nivolumab/relatlimab-rmbw) • Opdivo Qvantig (nivolumab and hyaluronidase-nvhy)
    4ms
    Neo ReNi II: A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, Melanoma Institute Australia | Trial completion date: Jan 2036 --> Oct 2035
    Trial completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • NRAS mutation • NRAS wild-type
    |
    Opdualag (nivolumab/relatlimab-rmbw)
    4ms
    Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (clinicaltrials.gov)
    P1/2, N=15, Recruiting, University of Wisconsin, Madison | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRAF (B-raf proto-oncogene)
    |
    melphalan • Opdualag (nivolumab/relatlimab-rmbw) • Melblez Kit (melphalan hepatic delivery system) • relatlimab (BMS-986016)
    5ms
    Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov)
    P2, N=90, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2027 --> Nov 2028 | Trial primary completion date: Jul 2027 --> Nov 2028
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    LDH elevation
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    5ms
    Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma (clinicaltrials.gov)
    P2, N=105, Recruiting, NYU Langone Health | N=69 --> 105 | Trial completion date: Dec 2025 --> Feb 2028 | Trial primary completion date: Jun 2025 --> Aug 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Opdualag (nivolumab/relatlimab-rmbw) • Kevzara (sarilumab)