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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 Pharma
    Drug class:
    PD1 inhibitor, LAG-3 inhibitor
    Related drugs:
    15h
    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: Mar 2027 --> Jul 2027 | Trial primary completion date: Mar 2027 --> Jul 2027
    Trial completion date • Trial primary completion date • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    9d
    Agilent Companion Diagnostic Assay PD-L1 IHC 28-8 pharmDx Receives European IVDR Certification (Businesswire)
    "Agilent’s PD-L1 IHC 28-8 pharmDx (Code SK005) provides clinically relevant information about PD-L1 expression – a critical biomarker for potential response to therapies containing anti-PD-1 antibodies such as OPDIVO (nivolumab) which has demonstrated therapeutic value across growing list of cancer types and Opdualag (nivolumab and relatimab)....PD-L1 IHC 28-8 pharmDx (Code SK005) has received European IVDR certification for nine cancer indications, including five companion diagnostic indications; non-small cell lung cancer (NSCLC), muscle invasive urothelial carcinoma (MIUC), melanoma, esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ) and esophageal adenocarcinoma."
    PD-L1 IHC 28-8 pharmDx
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
    10d
    IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (clinicaltrials.gov)
    P3, N=680, Recruiting, Immunocore Ltd | Trial primary completion date: Dec 2026 --> Oct 2027
    Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    BRAF mutation • BRAF V600 • HLA-A*02
    |
    Opdualag (nivolumab/relatlimab-rmbw) • brenetafusp (IMC-F106C) • relatlimab (BMS-986016)
    12d
    CA209-1451: Neoadjuvant Opdualag Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, University of California, San Diego | Initiation date: Oct 2024 --> Jan 2025
    Trial initiation date
    |
    Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    13d
    A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations (clinicaltrials.gov)
    P2, N=100, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw) • nivolumab subcutaneous (BMS-986298)
    15d
    RELATIVITY-127: A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (clinicaltrials.gov)
    P3, N=570, Recruiting, Bristol-Myers Squibb | Trial completion date: Feb 2025 --> Aug 2025 | Trial primary completion date: Feb 2025 --> Aug 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
    16d
    Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Stanford University
    New P2 trial
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw)
    20d
    A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC) (clinicaltrials.gov)
    P2, N=15, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw)
    28d
    A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=413, Not yet recruiting, Bristol-Myers Squibb
    New P1/2 trial • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • Opdualag (nivolumab/relatlimab-rmbw) • nivolumab subcutaneous (BMS-986298)
    1m
    OPAL-1: A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=140, Recruiting, Krystal Biotech, Inc. | Phase classification: P1 --> P1/2 | N=80 --> 140
    Phase classification • Enrollment change
    |
    Opdualag (nivolumab/relatlimab-rmbw)
    1m
    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 | Phase classification: P1 --> P2
    Phase classification
    |
    PD-L1 (Programmed death ligand 1)
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    1m
    Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors (clinicaltrials.gov)
    P1, N=33, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    2ms
    Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases (clinicaltrials.gov)
    P2, N=30, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Dec 2024 --> Jul 2025
    Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
    3ms
    Neoadjuvant Opdualag Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, University of California, San Diego
    New P2 trial
    |
    Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    3ms
    RELATIVITY1093: 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 1-49% (clinicaltrials.gov)
    P3, N=800, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • carboplatin • pemetrexed • Opdualag (nivolumab/relatlimab-rmbw)
    4ms
    CA209-6D9: Pilot Study of Nivolumab w/Ipilimumab or Relatlimab in Surgically Resectable Melanoma Brain Metastases (clinicaltrials.gov)
    P1, N=1, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2026 --> Jun 2025 | Trial primary completion date: Dec 2025 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    4ms
    RELATIVITY1093: 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 1-49% (clinicaltrials.gov)
    P3, N=800, Not yet recruiting, Bristol-Myers Squibb
    New P3 trial • IO biomarker • Tumor cell • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • carboplatin • pemetrexed • Opdualag (nivolumab/relatlimab-rmbw)
    4ms
    First-Line Nivolumab Plus Relatlimab Versus Nivolumab Plus Ipilimumab in Advanced Melanoma: An Indirect Treatment Comparison Using RELATIVITY-047 and CheckMate 067 Trial Data. (PubMed, J Clin Oncol)
    Nivolumab plus relatlimab demonstrated similar efficacy to nivolumab plus ipilimumab in the overall population, including most-but not all-subgroups, and improved safety in patients with untreated advanced melanoma. Results should be interpreted with caution.
    Journal • PD(L)-1 Biomarker • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw)
    4ms
    A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P3, N=560, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Libtayo (cemiplimab-rwlc) • Opdualag (nivolumab/relatlimab-rmbw) • fianlimab (REGN3767) • relatlimab (BMS-986016)
    5ms
    VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3) (clinicaltrials.gov)
    P3, N=400, Recruiting, Replimune Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • temozolomide • albumin-bound paclitaxel • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016) • vusolimogene oderparepvec (RP1)
    5ms
    CLEAR-Me: Interception trial to detect and clear molecular residual disease in patients with high-risk melanoma (ESMO 2024)
    Pts are randomly assigned (2:1) to receive treatment with BMS-986213 (Arm A: nivolumab/relatlimab) IVQ4W or monotherapy with anti-PD-1 (Arm B: nivolumab) IVQ4W for up to 12 doses. Study enrolment is ongoing. A total of 270 pts will be pre-screened for ctDNA detection with a target accrual of 54 ctDNA-positive pts, of whom 36 will be randomized to Arm A and 18 to Arm B.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    RaDaR™ assay
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
    5ms
    RELATIVITY-020: 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 (clinicaltrials.gov)
    P1/2, N=1499, Active, not recruiting, Bristol-Myers Squibb | Trial primary completion date: Oct 2024 --> May 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    5ms
    ClearMe: Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma (clinicaltrials.gov)
    P2, N=54, Recruiting, University Health Network, Toronto | Initiation date: May 2024 --> Jul 2024
    Trial initiation date
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
    5ms
    CA209-6D9: Pilot Study of Nivolumab w/Ipilimumab or Relatlimab in Surgically Resectable Melanoma Brain Metastases (clinicaltrials.gov)
    P1, N=1, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Jan 2027 --> Dec 2025
    Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    6ms
    Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov)
    P1, N=90, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | N=30 --> 90
    Enrollment change • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    6ms
    RELATIVITY-020: 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 (clinicaltrials.gov)
    P1/2, N=1499, Active, not recruiting, Bristol-Myers Squibb | Trial primary completion date: May 2024 --> Oct 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    6ms
    CA224-1065: Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Melanoma Institute Australia | Trial completion date: Apr 2036 --> Jul 2036 | Initiation date: Apr 2024 --> Jul 2024 | Trial primary completion date: Jun 2026 --> Sep 2026
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    6ms
    Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases (clinicaltrials.gov)
    P2, N=30, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
    7ms
    RELATIVITY-020: 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 (clinicaltrials.gov)
    P1/2, N=1499, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Sep 2024 --> Jan 2025 | Trial primary completion date: Sep 2024 --> May 2024
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    8ms
    Pseudoprogression in a patient with metastatic melanoma treated with PD-1 and LAG-3 inhibition. (PubMed, Melanoma Res)
    Here, we report a case of an 89-year-old patient with metastatic melanoma to the liver, lung and lymph nodes, who underwent treatment with Opdualag (combining anti-PD-1 nivolumab and anti-lymphocyte-activation gene 3 relatlimab ICBs), and developed pseudoprogression after two cycles of therapy. The patient experienced a radiographic increase in liver metastatic lesion size, but was found to have a subsequent reduction in these lesions. The patient has been on therapy for 18 months without evidence of disease progression and continues to be clinically well-appearing.
    Journal • Metastases
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    8ms
    Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases (clinicaltrials.gov)
    P2, N=9, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=30 --> 9
    Enrollment closed • Enrollment change • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
    8ms
    Pan Tumor Rollover Study (clinicaltrials.gov)
    P2, N=1500, Recruiting, Bristol-Myers Squibb | N=800 --> 1500 | Trial completion date: Aug 2025 --> Aug 2029 | Trial primary completion date: Aug 2025 --> Aug 2029
    Enrollment change • Trial completion date • Trial primary completion date • Pan tumor
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • 5-fluorouracil • sunitinib • temozolomide • capecitabine • Xtandi (enzalutamide) • Cabometyx (cabozantinib tablet) • Rubraca (rucaparib) • Stivarga (regorafenib) • pemetrexed • oxaliplatin • Darzalex (daratumumab) • leucovorin calcium • Opdualag (nivolumab/relatlimab-rmbw)
    9ms
    Pilot Study of Nivolumab w/Ipilimumab or Relatlimab in Surgically Resectable Melanoma Brain Metastases (clinicaltrials.gov)
    P1, N=1, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=24 --> 1
    Enrollment closed • Enrollment change
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    PD-1 expression
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    9ms
    ClearMe: Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma (clinicaltrials.gov)
    P2, N=54, Recruiting, University Health Network, Toronto
    New P2 trial
    |
    Opdualag (nivolumab/relatlimab-rmbw)
    9ms
    Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting
    Enrollment open
    |
    TMB (Tumor Mutational Burden)
    |
    PD-L1 expression
    |
    PD-L1 IHC 28-8 pharmDx
    |
    Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    10ms
    Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov)
    P1, N=30, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    10ms
    Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P1 trial • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    10ms
    CA224-1065: Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Melanoma Institute Australia
    New P2 trial
    |
    Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
    10ms
    RELATIVITY-123: A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=700, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • RAS wild-type
    |
    Opdivo (nivolumab) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil) • Opdualag (nivolumab/relatlimab-rmbw)
    10ms
    IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (clinicaltrials.gov)
    P3, N=680, Recruiting, Immunocore Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    BRAF mutation • BRAF V600 • HLA-A*02
    |
    Opdualag (nivolumab/relatlimab-rmbw) • brenetafusp (IMC-F106C) • relatlimab (BMS-986016)
    10ms
    VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3) (clinicaltrials.gov)
    P3, N=400, Not yet recruiting, Replimune Inc.
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • temozolomide • albumin-bound paclitaxel • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016) • vusolimogene oderparepvec (RP1)
    10ms
    RELATIVITY-020: 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 (clinicaltrials.gov)
    P1/2, N=1499, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Aug 2026 --> Sep 2024
    Trial completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)