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    DRUG:

    spartalizumab (PDR001)

    i
    Other names: PDR001, PDR 001, PDR-001
    Company:
    Novartis
    Drug class:
    PD1 inhibitor
    Related drugs:
    1m
    Biomarker analysis from patients with metastatic PDAC treated with TGFβ antibody, NIS793, plus abraxane+gemcitabine vs. abraxane+gemcitabine alone in a phase II, open label, randomized study. (PubMed, Clin Cancer Res)
    NIS793 effectively inhibited TGFβ signaling and led to stroma remodeling but failed to improve outcomes in metastatic PDAC. These findings highlight the complexity of TGFβ biology and caution against its blockade in combination with chemotherapy for PDAC. Future strategies should consider context-dependent effects of TGFβ inhibition(NCT04390763).
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    ACTA2 (Actin Alpha 2 Smooth Muscle) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    gemcitabine • albumin-bound paclitaxel • spartalizumab (PDR001) • nisevokitug (NIS793)
    3ms
    GASPAR: Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT) (clinicaltrials.gov)
    P2, N=67, Completed, Centre Francois Baclesse | Trial completion date: Mar 2027 --> Nov 2025 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
    |
    docetaxel • 5-fluorouracil • oxaliplatin • spartalizumab (PDR001) • leucovorin calcium
    4ms
    SPARC-1: A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P1, N=17, Completed, Columbia University | Active, not recruiting --> Completed
    Trial completion
    |
    CD4 (CD4 Molecule)
    |
    spartalizumab (PDR001) • Ilaris (canakinumab)
    5ms
    CDFF332A12101: DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov)
    P1, N=40, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business decision and not related to safety concerns
    Trial termination • IO biomarker • First-in-human
    |
    VHL (von Hippel-Lindau tumor suppressor) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B) • EPAS1 (Endothelial PAS domain protein 1) • SDHC (Succinate Dehydrogenase Complex Subunit C) • SDHD (Succinate Dehydrogenase Complex Subunit D) • SDHAF2 (Succinate Dehydrogenase Complex Assembly Factor 2) • SDHA (Succinate Dehydrogenase Complex Flavoprotein Subunit A)
    |
    VHL mutation
    |
    everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)
    7ms
    Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov)
    P1, N=98, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Oct 2026 | Trial primary completion date: Mar 2026 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    spartalizumab (PDR001) • DKY709
    7ms
    SPARTO: Spartalizumab and Low-dose PAzopanib in Refractory or Relapsed Solid TumOrs of Pediatric and Adults (clinicaltrials.gov)
    P1/2, N=80, Active, not recruiting, University Hospital, Bordeaux | Recruiting --> Active, not recruiting | N=59 --> 80 | Trial primary completion date: Nov 2026 --> Aug 2025
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    pazopanib • spartalizumab (PDR001)
    9ms
    Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov)
    P1, N=98, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2025 --> Mar 2026
    Trial completion date
    |
    spartalizumab (PDR001) • DKY709
    10ms
    PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • spartalizumab (PDR001)
    10ms
    Efficacy of anti-PD1 therapy in PD1-high mRNA tumors across multiple cancer types: results from cohort 1 and cohort 2 of the phase II SOLTI-1904 ACROPOLI trial. (PubMed, ESMO Open)
    PD1 mRNA may help identify immunogenic tumors across cancer types. However, the trial's early closure and exploratory nature warrant further validation. A composite biomarker strategy integrating immune and tumor-intrinsic features may improve patient selection for ICIs.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    spartalizumab (PDR001)
    11ms
    Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Sep 2025 --> Sep 2026
    Trial completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    spartalizumab (PDR001) • sabatolimab (MBG453)
    11ms
    Testing if PDR-001 Can Safely and Effectively Remove Harmful Brain Protein in Parkinson's Disease (clinicaltrials.gov)
    P1, N=12, Recruiting, Ruijin Hospital
    New P1 trial
    |
    spartalizumab (PDR001)
    1year
    SPARC-1: A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, Columbia University | Recruiting --> Active, not recruiting | Trial completion date: Dec 2026 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    spartalizumab (PDR001) • Ilaris (canakinumab)