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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
    Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=330, Recruiting, I-Mab Biopharma US Limited | N=168 --> 330 | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    Opdivo (nivolumab) • Imfinzi (durvalumab) • givastomig (TJ-CD4B)
    1d
    CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer (clinicaltrials.gov)
    P1, N=31, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    CXCL8 (Chemokine (C-X-C motif) ligand 8)
    |
    Opdivo (nivolumab) • Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • Cdactin-O (CBM588)
    2d
    A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) (clinicaltrials.gov)
    P1/2, N=234, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • pumitamig (BNT327)
    2d
    NRG-BN007: Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma (clinicaltrials.gov)
    P2/3, N=159, Completed, National Cancer Institute (NCI) | Trial completion date: Sep 2026 --> Dec 2025 | Active, not recruiting --> Completed
    Trial completion • Trial completion date • Tumor mutational burden
    |
    PD-L1 (Programmed death ligand 1) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    MGMT promoter methylation • IDH1 R132
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • temozolomide • ABP 206 (nivolumab biosimilar)
    2d
    CIME/ET23-185: Study aiming to compare the survival of patients with locally advanced or metastatic MSI/dMMR Esogastric adenocarcinomas treated by a combination of Immune checkpoint inhibitors (botensilimab + balstilimab) versus the standard of care (FOLFOX/XELOX + nivolumab) (2023-506291-28-00)
    P2/3, N=132, Recruiting, Centre Leon Berard | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition • dMMR
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR • HER-2 negative
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2d
    Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (clinicaltrials.gov)
    P2, N=720, Recruiting, Canadian Cancer Trials Group | Trial primary completion date: Jan 2026 --> Dec 2026
    Trial primary completion date • Tumor mutational burden • Pan tumor
    |
    BRAF (B-raf proto-oncogene)
    |
    Opdivo (nivolumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Xalkori (crizotinib) • erlotinib • Yervoy (ipilimumab) • Ibrance (palbociclib) • dasatinib • Zelboraf (vemurafenib) • sunitinib • Perjeta (pertuzumab) • Cotellic (cobimetinib) • bosutinib • Tukysa (tucatinib) • temsirolimus • axitinib • Erivedge (vismodegib)
    2d
    Safe Stop Trial Melanoma (2024-516937-10-01`2018-001384-23)
    P2/3, N=200, Recruiting, Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab)
    2d
    Safe Stop ipi-nivo (2024-516938-34-00`2022-002673-28)
    P2/3, N=80, Recruiting, Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab)
    2d
    A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=542, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    BRAF mutation • HER-2 negative • RAS mutation
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • Yervoy (ipilimumab) • SAR445877 • muzastotug (ADG126)
    2d
    Nivolumab for unresectable cutaneous epithelial malignancies: an open-label, single-arm, multi-centre, phase II trial (NMSC-PD1). (PubMed, BMC Cancer)
    Nivolumab showed durable antitumour activity with manageable toxicity in Japanese patients with advanced NMSCs, including rare non-cSCC. The lower ORR compared with Western trials may reflect intrinsic biological differences and support biomarker-driven, region-specific immunotherapy.
    P2 data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden) • PD-1 (Programmed cell death 1)
    |
    Opdivo (nivolumab)
    2d
    Androgen deprivation, androgen receptor-targeted vaccination, and nivolumab in patients with high-risk localized prostate cancer. (PubMed, J Immunother Cancer)
    In this first stage of a pilot study that awaits confirmation with larger numbers of patients, our results suggest that vaccination targeting AR given prior to androgen deprivation therapy might improve outcome for patients with high-risk prostate cancer. Contrary to our initial hypothesis, this was not improved with the addition of PD-1 blockade, possibly due to the activation of regulatory CD4+T cells.
    Journal
    |
    AR (Androgen receptor) • CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Firmagon (degarelix) • MVI-118
    2d
    A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer (clinicaltrials.gov)
    P2, N=39, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • 5-fluorouracil • Stivarga (regorafenib) • oxaliplatin • leucovorin calcium