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    DRUG:

    spartalizumab (PDR001)

    i
    Other names: PDR001, PDR 001, PDR-001
    Company:
    Novartis
    Drug class:
    PD1 inhibitor
    Related drugs:
    2d
    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
    25d
    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)
    2ms
    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) • SDHA (Succinate Dehydrogenase Complex Flavoprotein Subunit A) • SDHAF2 (Succinate Dehydrogenase Complex Assembly Factor 2)
    |
    VHL mutation
    |
    everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)
    4ms
    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
    4ms
    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)
    6ms
    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
    7ms
    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)
    7ms
    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)
    8ms
    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)
    8ms
    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)
    9ms
    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)
    10ms
    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, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Sep 2025 --> Mar 2026 | Trial primary completion date: Sep 2025 --> Mar 2026
    Trial completion date • Trial primary completion date • IO biomarker
    |
    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) • SDHA (Succinate Dehydrogenase Complex Flavoprotein Subunit A) • SDHAF2 (Succinate Dehydrogenase Complex Assembly Factor 2)
    |
    VHL mutation
    |
    everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)