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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
    CYTOSHRINK: SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, Ontario Clinical Oncology Group (OCOG) | Trial completion date: Apr 2026 --> Jul 2026
    Trial completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    1d
    PRiME II: PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma (clinicaltrials.gov)
    P1/2, N=68, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • temozolomide
    1d
    Sarcomatoid Transformation of Pulmonary Mucinous Adenocarcinoma as a Mechanism of Immunotherapy Resistance. (PubMed, Thorac Cancer)
    As surgical resection was not feasible, first-line treatment with ipilimumab plus nivolumab combined with chemotherapy was initiated, resulting in a partial response...Thirteen months later, the patient developed radiographic worsening of ILD, for which oral prednisolone was initiated...The patient received two cycles of nab-paclitaxel plus carboplatin without response and subsequently died. These findings emphasize that clinicians should recognize that IMA may undergo sarcomatous transformation.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • NKX2-1 (NK2 Homeobox 1) • VIM (Vimentin)
    |
    BRAF mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • albumin-bound paclitaxel • prednisolone
    1d
    D9803C00001: A trial to learn how well sonesitatug vedotin and capecitabine with or without rilvegostomig work and how safe they are in adults with cancers of the stomach and esophagus. (2024-519787-40-00)
    P2/3, N=126, Not yet recruiting, AstraZeneca AB
    New P2/3 trial
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN1 positive
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • Vyloy (zolbetuximab-clzb) • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    1d
    GS-US-742-7757: Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas (2025-524095-27-00)
    P1/2, N=45, Not yet recruiting, Gilead Sciences Inc.
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    PD-L1 expression • HER-2 negative
    |
    Opdivo (nivolumab) • albumin-bound paclitaxel • Cyramza (ramucirumab) • denikitug (GS-1811)
    1d
    Clinical efficacy of anti-PD-1 immunotherapy with localized non-ablative irradiation against metastatic lymph node in patients with metastatic gastric cancer. (PubMed, Clin Transl Radiat Oncol)
    The time-dependent ROC AUC at both the level of IL-1ra and frequency of CD8(+)CD45RO(+)CD27(+)CD127(+) T cells significantly predict OS (p = 0.0193 and p = 0.0442). These preliminary findings indicated that localized non-ablative irradiation against metastatic lymph node has a potential to enhance the clinical efficacy of anti-PD-1 immunotherapy in patients with m-GC, and IL-1ra level and frequency of CD8(+)CD45RO(+)CD27(+)CD127(+) T cells in peripheral blood before treatment may be candidate biomarkers to predict clinical efficacy of Nivo-lRT_mLN.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IL7R (Interleukin 7 Receptor) • CD27 (CD27 Molecule) • IL1R1 (Interleukin 1 receptor, type I)
    |
    Opdivo (nivolumab)
    1d
    Neoadjuvant Lymph Node Targeted Immunotherapy in Cervical Cancer: a Feasibility Study (NEOLYNC) (clinicaltrials.gov)
    P1, N=12, Recruiting, University Medical Center Groningen
    New P1 trial
    |
    Opdivo (nivolumab)
    2d
    A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma (clinicaltrials.gov)
    P1/2, N=41, Active, not recruiting, Ravi Amaravadi, MD | Recruiting --> Active, not recruiting | N=94 --> 41 | Trial completion date: Jan 2027 --> May 2027 | Trial primary completion date: Jan 2027 --> Jul 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • hydroxychloroquine
    2d
    REVIVE: A Study Evaluating The Combination of Immunotherapy With Radiotherapy in Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=39, Recruiting, University of Chicago | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • Imfinzi (durvalumab) • gemcitabine • docetaxel • Cyramza (ramucirumab) • Libtayo (cemiplimab-rwlc)
    2d
    WITNESS: Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer (clinicaltrials.gov)
    P=N/A, N=623, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed
    Trial completion
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    3d
    Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer (clinicaltrials.gov)
    P2, N=50, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • ABP 206 (nivolumab biosimilar)
    3d
    Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Sabine Mueller, MD, PhD | Recruiting --> Active, not recruiting | N=20 --> 9 | Trial completion date: Mar 2029 --> Jun 2028 | Trial primary completion date: Mar 2026 --> Jun 2028
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Checkpoint inhibition • Tumor mutational burden
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab)