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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
    STELLAR-002: Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors (clinicaltrials.gov)
    P1, N=1314, Recruiting, Exelixis | Active, not recruiting --> Recruiting
    Enrollment open
    |
    FH (Fumarate Hydratase)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016) • zanzalintinib (XL092)
    1d
    Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma (clinicaltrials.gov)
    P1/2, N=7, Terminated, Servier Bio-Innovation LLC | Completed --> Terminated; The sponsor decided to terminate the study during the safety lead-in phase.
    Trial termination
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Tibsovo (ivosidenib)
    1d
    A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P=N/A, N=50, Active, not recruiting, Yonsei University | Trial completion date: Feb 2023 --> Sep 2026 | Trial primary completion date: Dec 2022 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab)
    1d
    Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) (clinicaltrials.gov)
    P3, N=450, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial
    |
    Opdivo (nivolumab) • Ibrance (palbociclib) • everolimus • Lenvima (lenvatinib) • Cabometyx (cabozantinib tablet) • Welireg (belzutifan)
    2d
    A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK) (clinicaltrials.gov)
    P1, N=35, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial • First-in-human
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • HC-7366
    2d
    CA224-094: Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma (clinicaltrials.gov)
    P2, N=27, Completed, Jose Lutzky, MD | Active, not recruiting --> Completed
    Trial completion
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Opdivo (nivolumab) • relatlimab (BMS-986016)
    2d
    NEOREM-NEO-1: Neo-adjuvant Immunotherapy in Patients With Localized Melanoma (clinicaltrials.gov)
    P2, N=50, Recruiting, UNICANCER | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    2d
    Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors (clinicaltrials.gov)
    P2, N=314, Recruiting, National Cancer Institute (NCI) | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • ABP 206 (nivolumab biosimilar)
    3d
    TORCH-OPTIMA: Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=114, Not yet recruiting, Fudan University
    New P2 trial • Mismatch repair • MSI-H • dMMR
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    3d
    Cytomegalovirus gastritis following immune checkpoint inhibitor-associated gastritis induced by ipilimumab and nivolumab therapy in a patient with renal cell carcinoma. (PubMed, Clin J Gastroenterol)
    Valganciclovir was initiated, and prednisolone was discontinued. Although irAE gastritis is a rare complication of ICI therapy, it should be considered in patients presenting with upper gastrointestinal symptoms during treatment. The management of irAE gastritis requires vigilance for opportunistic infections, timely histopathological evaluation, and careful differentiation from viral infections, especially in cases refractory to corticosteroids.
    Journal • Checkpoint inhibition
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Valcyte (valganciclovir)
    3d
    A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor (clinicaltrials.gov)
    P1/2, N=125, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • eribulin liposomal (E7389-LF)
    3d
    ECTOP-1036: Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC (clinicaltrials.gov)
    P2, N=116, Recruiting, Fudan University
    New P2 trial
    |
    Opdivo (nivolumab) • carboplatin • paclitaxel • Hetronifly (serplulimab)