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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
    NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Feb 2026 --> Feb 2027
    Trial completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • TMB (Tumor Mutational Burden)
    |
    HR positive • HER-2 amplification • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive
    |
    MSK-IMPACT • OncoPanel™ Assay
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    1d
    Inbraced: Phase I Study of 131-I mIBG Followed by Nivolumab & Dinutuximab Beta Antibodies in Children With Relapsed/Refractory Neuroblastoma (clinicaltrials.gov)
    P1, N=44, Active, not recruiting, University Hospital Southampton NHS Foundation Trust | Trial completion date: Nov 2025 --> Sep 2026
    Trial completion date
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Qarziba (dinutuximab beta) • Azedra (iobenguane I 131)
    2d
    CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer (clinicaltrials.gov)
    P1, N=42, Recruiting, Washington University School of Medicine | Trial completion date: Jun 2028 --> Apr 2029 | Trial primary completion date: Sep 2027 --> Jul 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Herceptin (trastuzumab) • 5-fluorouracil • leucovorin calcium • emavusertib (CA-4948)
    2d
    ECTOP- 1030: Perioperative Immunotherapy for NSCLC (ECTOP-1030) (clinicaltrials.gov)
    P2, N=0, Withdrawn, Fudan University | N=200 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab)
    2d
    Site-Specific Genomic Markers Associated with Outcomes of PD-1 Blockade in Gastric and Esophagogastric Junction Cancer: Analysis of Japan's C-CAT Registry. (PubMed, BioDrugs)
    In this large Japanese real-world cohort, genomic associations with nivolumab outcomes differed by tumor site. In gastric cancer, ASXL1 mutation was associated with prolonged treatment benefit under PD-1 blockade, while CDH1 and FANCG showed exploratory associations with OS. These findings warrant further validation in prospective and platform-controlled analyses.
    Journal • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    MSI (Microsatellite instability) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • ASXL1 (ASXL Transcriptional Regulator 1) • CDH1 (Cadherin 1) • MUTYH (MutY homolog) • FANCG (FA Complementation Group G)
    |
    MSI-H/dMMR • ASXL1 mutation
    |
    Opdivo (nivolumab)
    3d
    Phase 2 Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL (clinicaltrials.gov)
    P2, N=15, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    Opdivo (nivolumab) • doxorubicin hydrochloride • dacarbazine • vinblastine
    3d
    GDFATHERHCC01: Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure (clinicaltrials.gov)
    P2, N=104, Recruiting, CatalYm GmbH
    Trial initiation date
    |
    Opdivo (nivolumab) • Lenvima (lenvatinib) • visugromab (CTL-002)
    3d
    Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study (clinicaltrials.gov)
    P2, N=54, Recruiting, Vanderbilt-Ingram Cancer Center | Trial completion date: Jul 2026 --> Jul 2027 | Trial primary completion date: Oct 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet)
    3d
    Vulvar and Vaginal Melanoma: Real-world Clinical Outcomes and Prognostic Differences From a Single-center Experience. (PubMed, J Low Genit Tract Dis)
    Vulvar and vaginal melanoma present unique diagnostic and therapeutic challenges in gynecologic oncology. Site-specific prognosis and distinct response patterns to immunotherapy underscore the importance of individualized management strategies and multidisciplinary coordination in this rare population.
    Clinical data • Journal • Real-world evidence
    |
    IL2 (Interleukin 2)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab)
    3d
    Combined Nivolumab and Ipilimumab Therapy Promotes Immune-Mediated Cardiomyocyte Apoptosis Through TLR4-Myd88-NF-Κb-Driven Activation of the NLRP3 Inflammasome. (PubMed, Hum Mutat)
    However, because the combination group received a higher total antibody dose, the current study does not distinguish whether this difference reflects increased total drug exposure, additivity, or the specific contribution of CTLA-4 blockade. Bioactive constituents of Caulis sinomenii, particularly sinomenine, may represent potential cardioprotective modulators against ICI-induced cardiac injury.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • TLR4 (Toll Like Receptor 4) • NLRP3 (NLR Family Pyrin Domain Containing 3)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    3d
    Systematic Management of a Critical CYP3A4 Interaction Between Cabozantinib and Carbamazepine: A Case Report of a Clinically Relevant Pharmacokinetic Interaction. (PubMed, Clin Case Rep)
    This was the case of a 62-year-old patient treated with cabozantinib and nivolumab for metastatic clear cell renal cell carcinoma, in whom a clinically significant pharmacokinetic interaction with carbamazepine was observed...This optimization was accompanied by a significant clinical improvement and radiological tumor control. This case has led to the ongoing need for a medication review before initiating this type of cancer treatment and the implementation of pharmacokinetic monitoring when an interaction was detected.
    PK/PD data • Journal
    |
    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    Opdivo (nivolumab) • Cabometyx (cabozantinib tablet)
    3d
    Phase II study of axitinib intensification plus standard of care (SOC) compared to SOC alone after induction with nivolumab plus ipilimumab in mRCC patients without previous complete response (AxIn study). (2024-511397-70-00)
    P1/2, N=178, Recruiting, Consorzio Oncotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • axitinib