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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:
    1d
    Exploring plasma cell-free RNA biomarkers for predicting immune checkpoint inhibitor efficacy in gastric cancer: a translational sub-study of the KSCC VOYAGER phase II trial. (PubMed, Int J Clin Oncol)
    Elevated RIPK4 expression in plasma-derived cfRNA and tumor tissue was associated with a poor response to nivolumab, suggesting that RIPK4 may serve as a biomarker of ICI efficacy in gastric cancer. Further studies are warranted to validate its clinical utility.
    P2 data • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1)
    |
    Opdivo (nivolumab)
    1d
    Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation (clinicaltrials.gov)
    P2, N=9, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=20 --> 9
    Enrollment closed • Enrollment change
    |
    clonoSEQ®
    |
    Opdivo (nivolumab) • Imbruvica (ibrutinib) • cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV
    1d
    Neoadjuvant nivolumab plus chemotherapy in resectable NSCLC: A pharmacological outcome study. (PubMed, Pak J Pharm Sci)
    Neoadjuvant nivolumab combined with platinum-based chemotherapy demonstrates favorable pharmacological efficacy, manageable toxicity and biomarker-driven therapeutic response in resectable NSCLC under real-world clinical conditions. These findings support the role of personalized immunopharmacotherapy and reinforce the clinical relevance of biomarker-guided drug selection in modern pharmaceutical oncology.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
    |
    PD-L1 expression • KRAS mutation • PD-L1 overexpression
    |
    Opdivo (nivolumab)
    1d
    Lung-Map Sub-Study: Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers (clinicaltrials.gov)
    P3, N=275, Active, not recruiting, SWOG Cancer Research Network | Trial completion date: Apr 2026 --> Apr 2027
    Trial completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    1d
    eVOLVE-Meso: MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma (clinicaltrials.gov)
    P3, N=861, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2027 --> Nov 2028
    Enrollment closed • Trial primary completion date
    |
    Opdivo (nivolumab) • cisplatin • Yervoy (ipilimumab) • carboplatin • pemetrexed • volrustomig (MEDI5752)
    2d
    IMCODE-004: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC) (clinicaltrials.gov)
    P2, N=62, Recruiting, Hoffmann-La Roche | N=362 --> 62
    Enrollment change
    |
    Opdivo (nivolumab) • autogene cevumeran (RG6180)
    2d
    Pathological Complete Response to Nivolumab Plus Ipilimumab Combination Therapy in Advanced Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus. (PubMed, IJU Case Rep)
    Histopathological examination following radical nephrectomy with tumor thrombectomy demonstrated a pathological complete response. Diffuse programmed death-ligand 1 expression on pretreatment biopsy may have been associated with a favorable response to nivolumab plus ipilimumab.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    2d
    Significant Response to Nivolumab Plus Ipilimumab in Metastatic Mucinous Tubular and Spindle Cell Carcinoma: A Case Report. (PubMed, IJU Case Rep)
    No disease progression was observed at 9 months. This case demonstrates the potential efficacy of combination immunotherapy in aggressive metastatic MTSCC.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden)
    |
    TMB-L
    |
    FoundationOne® CDx
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    2d
    A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, University Health Network, Toronto | Recruiting --> Active, not recruiting | Trial completion date: Aug 2026 --> Aug 2027 | Trial primary completion date: Aug 2026 --> Aug 2027
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    2d
    Lectin-captured plasma microRNAs predict response and survival in patients with non-small cell lung cancer treated with nivolumab. (PubMed, Oncol Lett)
    In conclusion, OAA1-enriched plasma miRNAs may be associated with resistance to nivolumab and a poor prognosis in NSCLC. This glycan-based enrichment strategy could enhance the clinical value of circulating miRNAs and may complement tissue-based biomarkers of ICI response.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    MIR320A (MicroRNA 320a) • MIR320B (MicroRNA 320b) • MIR3613 (MicroRNA 3613)
    |
    Opdivo (nivolumab)
    5d
    NAHL: Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=9, Active, not recruiting, University of Utah | Trial completion date: Apr 2028 --> Nov 2028 | Trial primary completion date: May 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Niktimvo (axatilimab-csfr)
    5d
    VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=18, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar) • Voyager-V1