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    DRUG:

    Opdivo (nivolumab)

    i
    Other names: ONO-4538, BMS-936558, MDX-1106, NSC 748726, ono-0123, GTPL7335, GTPL 7335, BMS936558, BMS 936558, GTPL-7335, MDX1106, MDX 1106, ONO4538, ONO 4538, NSC748726, NSC-748726
    Company:
    BMS, Ono Pharmaceutical
    Drug class:
    PD1 inhibitor
    Related drugs:
    1m
    First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE) (clinicaltrials.gov)
    P=N/A, N=200, Recruiting, Bristol-Myers Squibb
    New trial
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    1m
    Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=35, Recruiting, University of California, Irvine | Trial primary completion date: Jun 2026 --> Oct 2026
    Trial primary completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet)
    1m
    COLOMBE: Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, Centre Leon Berard
    New P1/2 trial
    |
    Opdivo (nivolumab) • Zyclara (imiquimod)
    1m
    Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Dana-Farber Cancer Institute | N=45 --> 30
    Enrollment change
    |
    SMARCB1 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily B, Member 1)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    1m
    A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma. (clinicaltrials.gov)
    P1, N=65, Active, not recruiting, Genentech, Inc. | Trial completion date: Jun 2027 --> Dec 2026 | Trial primary completion date: Jun 2027 --> Dec 2026
    Trial completion date • Trial primary completion date • IO biomarker
    |
    NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    NRAS mutation
    |
    Opdivo (nivolumab) • Cotellic (cobimetinib) • belvarafenib (RG6185)
    1m
    NCI-2018-01211: Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease (clinicaltrials.gov)
    P1, N=75, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    Opdivo (nivolumab)
    1m
    Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma (clinicaltrials.gov)
    P1, N=18, Recruiting, Washington University School of Medicine | Trial completion date: Jul 2031 --> Jan 2034 | Trial primary completion date: Aug 2026 --> Feb 2029
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • zanzalintinib (XL092)
    1m
    Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov)
    P1, N=40, Recruiting, Vanderbilt-Ingram Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab)
    1m
    DARANIVOVAX: Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, Georgetown University | Recruiting --> Active, not recruiting | N=54 --> 19
    Enrollment closed • Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase) • STK11 (Serine/threonine kinase 11)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Opdivo (nivolumab) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    1m
    PRIME-HCC: Safety and Bioactivity of Ipilimumab and Nivolumab Combination Prior to Liver Resection in Hepatocellular Carcinoma (clinicaltrials.gov)
    P1/2, N=33, Completed, Imperial College London | Recruiting --> Completed | Trial completion date: Dec 2023 --> Mar 2026 | Trial primary completion date: Sep 2023 --> Mar 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    1m
    Efficacy and safety of cabozantinib plus nivolumab in advanced non-clear cell renal cell carcinoma: a nationwide multicenter study. (PubMed, Oncoimmunology)
    Grade 3-4 treatment-emergent adverse events occurred in 46.8% of patients, and treatment discontinuation due to toxicity was reported in 6.5%. These findings demonstrate that cabozantinib plus nivolumab provides clinically meaningful and durable antitumor activity with manageable toxicity across diverse histologic subtypes in advanced nccRCC, supporting further prospective evaluation of cabozantinib plus nivolumab in advanced nccRCC.
    Clinical • Retrospective data • Journal
    |
    TFE3 (Transcription Factor Binding To IGHM Enhancer 3)
    |
    Opdivo (nivolumab) • Cabometyx (cabozantinib tablet)
    1m
    Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, Mayo Clinic | Trial completion date: Apr 2030 --> Jun 2029 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date
    |
    Opdivo (nivolumab) • oxaliplatin • leucovorin calcium • Proleukin (aldesleukin) • fluorouracil topical • ABP 206 (nivolumab biosimilar)