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    DRUG:

    Opdivo (nivolumab)

    i
    Other names: ONO-4538, BMS-936558, MDX-1106, NSC 748726, ono-0123, GTPL7335, NSC748726, NSC-748726, GTPL 7335, BMS936558, BMS 936558, GTPL-7335, MDX1106, MDX 1106, ONO4538, ONO 4538
    Company:
    BMS, Ono Pharmaceutical
    Drug class:
    PD1 inhibitor
    Related drugs:
    1d
    Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment (clinicaltrials.gov)
    P3, N=400, Recruiting, Boehringer Ingelheim
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 mutation
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Hernexeos (zongertinib)
    1d
    A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors (clinicaltrials.gov)
    P1, N=174, Not yet recruiting, Shanghai Henlius Biotech
    New P1 trial
    |
    Opdivo (nivolumab)
    1d
    AARON: Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML (clinicaltrials.gov)
    P2, N=30, Completed, Ludwig-Maximilians - University of Munich | Active, not recruiting --> Completed
    Trial completion
    |
    Opdivo (nivolumab) • azacitidine • relatlimab (BMS-986016)
    1d
    FRACTION: Fedratinib in Combination With Nivolumab (clinicaltrials.gov)
    P2, N=30, Completed, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Jan 2026 | Trial primary completion date: Mar 2026 --> Nov 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Inrebic (fedratinib)
    2d
    Predictive Value of Insertion/Deletion Rate in Patients With Gastric Cancer Treated With Nivolumab Plus Chemotherapy. (PubMed, J Gastric Cancer)
    Thus, Indel rate, particularly in combination with TMB, may be a promising predictive biomarker for gastric cancer. However, further validation of their predictive value is warranted.
    Retrospective data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden)
    |
    TMB-H • TMB-L
    |
    Opdivo (nivolumab)
    2d
    C-IT Neo: CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma (clinicaltrials.gov)
    P2, N=28, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    3d
    ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS) (clinicaltrials.gov)
    P1, N=120, Active, not recruiting, USWM CT, LLC | Trial primary completion date: Apr 2026 --> Dec 2026
    Trial primary completion date
    |
    MAGEA4 (Melanoma antigen family A, 4)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
    3d
    Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Jul 2026 --> Jul 2027
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • urelumab (BMS-663513)
    3d
    CheckMate 9DW: A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P3, N=732, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Nov 2026 --> Jul 2026 | Trial primary completion date: Nov 2026 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • sorafenib • Lenvima (lenvatinib)
    4d
    Defactinib, Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Emory University | Trial completion date: Sep 2028 --> Sep 2029 | Trial primary completion date: Mar 2028 --> Mar 2029
    Trial completion date • Trial primary completion date • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • STK11 (Serine/threonine kinase 11)
    |
    KRAS G12C • KRAS G12
    |
    Opdivo (nivolumab) • Avmapki (avutometinib) • Fakzynja (defactinib) • ABP 206 (nivolumab biosimilar)
    5d
    Comparative efficacy and safety of nivolumab-based combination therapies (with ipilimumab or binimetinib) in patients with microsatellite-stable and microsatellite-instability-high metastatic colorectal cancer: a systematic review and meta-analysis. (PubMed, Clin Transl Oncol)
    In metastatic CRC patients who receive nivolumab-based combination therapies demonstrate partial tumor responses that increase while their safety profile remains acceptable, but their overall response rates do not improve. The research demonstrates how immunotherapy serves as a standard treatment method for MSI-H disease while emphasizing the need to develop biomarker-driven approaches that enhance treatment selection methods, especially for MSS CRC.
    Retrospective data • Review • Journal • Microsatellite instability • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • MSI-H
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Mektovi (binimetinib)
    6d
    Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery (clinicaltrials.gov)
    P2, N=101, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Sep 2026 | Trial primary completion date: Jun 2026 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • ABP 206 (nivolumab biosimilar)