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    DRUG:

    spartalizumab (PDR001)

    i
    Other names: PDR001, PDR 001, PDR-001
    Company:
    Novartis
    Drug class:
    PD1 inhibitor
    Related drugs:
    7d
    Clinical and Biomarker Analysis of a Phase I/II Study of PDR001 plus Imatinib for Advanced Treatment-refractory Gastrointestinal Stromal Tumors. (PubMed, Clin Cancer Res)
    In patients with treatment-refractory GIST, PDR001 in combination with imatinib was generally tolerable, but it was not effective.
    P1/2 data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Stroma • Metastases
    |
    TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8)
    |
    imatinib • Sutent (sunitinib) • Stivarga (regorafenib) • spartalizumab (PDR001)
    17d
    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: May 2025 --> Sep 2024 | Trial primary completion date: May 2025 --> Sep 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    spartalizumab (PDR001) • DKY709
    22d
    SPARTO: Spartalizumab and Low-dose PAzopanib in Refractory or Relapsed Solid TumOrs of Pediatric and Adults (clinicaltrials.gov)
    P1/2, N=59, Recruiting, University Hospital, Bordeaux | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    Votrient (pazopanib) • spartalizumab (PDR001)
    23d
    COMBI-i: A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma (clinicaltrials.gov)
    P3, N=569, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2024 --> Aug 2024
    Trial completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • BRAF mutation • BRAF V600
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • spartalizumab (PDR001)
    2ms
    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: Jul 2025 --> Feb 2025 | Trial primary completion date: Jul 2025 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases • Immuno-oncology
    |
    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 • SDHB mutation
    |
    everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)
    3ms
    A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer (clinicaltrials.gov)
    P1, N=122, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: May 2024 --> Sep 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • Tevimbra (tislelizumab) • spartalizumab (PDR001) • naporafenib (ERAS-254) • batoprotafib (TNO155) • rineterkib (LTT462)
    3ms
    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: Apr 2024 --> May 2025 | Trial primary completion date: Apr 2024 --> May 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    spartalizumab (PDR001) • DKY709
    3ms
    A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov)
    P1, N=154, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2024 --> Nov 2024 | Trial primary completion date: Jun 2024 --> Nov 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    spartalizumab (PDR001) • LAE005
    3ms
    Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies (clinicaltrials.gov)
    P1, N=122, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business reasons
    Trial termination • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS G12C • EGFR wild-type • KRAS wild-type • RAS wild-type • KRAS G12 • EGFR wild-type + ALK wild-type
    |
    Kisqali (ribociclib) • spartalizumab (PDR001) • batoprotafib (TNO155)
    3ms
    Immunotherapy for endocrine tumours : a clinician's perspective. (PubMed, Endocr Relat Cancer)
    Pembrolizumab or spartalizumab can be utilized in patients with high TMB anaplastic thyroid cancer, obtaining better response rates particular in patients with high PD-L1 expression. Future research is needed to evaluate the potential role of immunohistochemical biomarkers, such as PD-1/PD-L1 and TMB, as predictors for response to immunotherapy. Furthermore, randomized prospective studies could provide more robust data on the efficacy and side effects of ICIs.
    Review • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden)
    |
    PD-L1 expression • TMB-H • PD-L1 overexpression
    |
    Keytruda (pembrolizumab) • spartalizumab (PDR001)
    4ms
    Checkpoint Inhibition in Addition to Dabrafenib/Trametinib for BRAF Mutated Anaplastic Thyroid Carcinoma. (PubMed, Thyroid)
    Our results show that in BRAFm-ATC, addition of pembrolizumab to dabrafenib/trametinib may significantly prolong survival. Surgical resection of the primary tumor after initial BRAF-targeted therapy in selected patients may provide further survival benefit. However, conclusions are limited by the retrospective nature of the study. Additional prospective data are needed to confirm this observation.
    Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • Mekinist (trametinib) • Tafinlar (dabrafenib) • spartalizumab (PDR001)
    4ms
    A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab (clinicaltrials.gov)
    P1, N=60, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business decision and not due to any safety concerns
    Trial termination • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab) • spartalizumab (PDR001) • NIZ985
    4ms
    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 • Combination therapy
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    spartalizumab (PDR001) • sabatolimab (MBG453)
    4ms
    SPARTANA: Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma (clinicaltrials.gov)
    P2, N=34, Recruiting, Centre Hospitalier Universitaire de Besancon | Phase classification: P2a --> P2 | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2023 --> Jun 2025
    Phase classification • Trial completion date • Trial primary completion date • Tumor mutational burden • Metastases
    |
    cisplatin • docetaxel • 5-fluorouracil • spartalizumab (PDR001)
    4ms
    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 | Recruiting --> Active, not recruiting | N=180 --> 40
    Enrollment closed • Enrollment change • Combination therapy • IO biomarker • Metastases • Immuno-oncology
    |
    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 • SDHB mutation
    |
    everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)
    5ms
    Phase I/Ib, open-label, multicenter, dose-escalation study of the anti-TGF-β monoclonal antibody, NIS793, in combination with spartalizumab in adult patients with advanced tumors. (PubMed, J Immunother Cancer)
    In patients with advanced solid tumors, proof of mechanism of NIS793 is supported by evidence of target engagement and TGF-β pathway inhibition.
    P1 data • Journal • Combination therapy • PD(L)-1 Biomarker • Metastases
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    spartalizumab (PDR001) • nisevokitug (NIS793)
    5ms
    First-in-human study of naporafenib (LXH254) with or without spartalizumab in adult patients with advanced solid tumors harboring MAPK signaling pathway alterations. (PubMed, Eur J Cancer)
    Naporafenib, with or without spartalizumab, showed an acceptable safety profile, pharmacodynamic activity and limited antitumor activity. Additional naporafenib combination therapies are currently under investigation.
    P1 data • Journal • PD(L)-1 Biomarker • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • DUSP6 (Dual specificity phosphatase 6)
    |
    KRAS mutation • NRAS mutation • DUSP6 expression
    |
    spartalizumab (PDR001) • naporafenib (ERAS-254)
    6ms
    First-in-human phase I/Ib study of NIZ985, a recombinant heterodimer of IL-15 and IL-15Rα, as a single agent and in combination with spartalizumab in patients with advanced and metastatic solid tumors. (PubMed, J Immunother Cancer)
    NIZ985 was well tolerated in the single-agent and NIZ985/spartalizumab regimens. The RDE was established at 1 µg/kg TIW. Antitumor activity of the combination was observed against tumor types known to have a poor response to ICIs.
    P1 data • Journal • Combination therapy • Metastases
    |
    CD8 (cluster of differentiation 8) • IL15 (Interleukin 15)
    |
    spartalizumab (PDR001) • NIZ985
    7ms
    COMBI-i: A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma (clinicaltrials.gov)
    P3, N=569, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2023 --> Mar 2024
    Trial completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • BRAF mutation • BRAF V600
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • spartalizumab (PDR001)
    7ms
    ALTER-PATH NeoDT: Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma (clinicaltrials.gov)
    P2, N=4, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Oct 2023 | Trial primary completion date: Feb 2024 --> Oct 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    BRAF V600E • BRAF V600K
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • spartalizumab (PDR001)
    7ms
    KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=77, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business reasons
    Trial termination • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    spartalizumab (PDR001) • KAZ954 • NZV930 • taminadenant (NIR178)
    8ms
    KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=77, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=145 --> 77
    Enrollment closed • Enrollment change • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    spartalizumab (PDR001) • KAZ954 • NZV930 • taminadenant (NIR178)
    8ms
    daNIS-1: Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (clinicaltrials.gov)
    P2, N=151, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Nov 2023 --> Apr 2024 | Trial primary completion date: Nov 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • PD-L1 expression + CD8 positive
    |
    gemcitabine • albumin-bound paclitaxel • spartalizumab (PDR001) • nisevokitug (NIS793)
    9ms
    KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=145, Recruiting, Novartis Pharmaceuticals | Trial completion date: Feb 2025 --> Sep 2023 | Trial primary completion date: Feb 2025 --> Sep 2023
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    spartalizumab (PDR001) • KAZ954 • NZV930 • taminadenant (NIR178)
    9ms
    Efficacy of spartalizumab across multiple cancer types in patients with PD1-high mRNA expressing tumors (SOLTI-1904 ACROPOLI) (ESMO 2023)
    Premature discontinuation of the trial's recruitment occurred due to the termination of the spartalizumab development program. Nevertheless, the trial will begin enrolling a new cohort of 111 patients with PD1-high tumors with tislelizumab.
    Clinical
    |
    PD-1 (Programmed cell death 1)
    |
    Tevimbra (tislelizumab) • spartalizumab (PDR001)
    9ms
    A phase I/Ib study evaluating the safety and tolerability of NIZ985 alone and in combination with spartalizumab (anti–PD-1) in patients (pts) with solid tumors or lymphoma (ESMO 2023)
    Clinical trial identification EudraCT 2109-0040690-42. The RDE was declared as 12 μg/kg NIZ985 SA and in combination. Additional pts with NSCLC have enrolled in EXP with tislelizumab.
    Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IL2 (Interleukin 2) • IL15 (Interleukin 15)
    |
    CD8 expression
    |
    Tevimbra (tislelizumab) • spartalizumab (PDR001) • NIZ985
    10ms
    ACROPOLI: Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors (clinicaltrials.gov)
    P2, N=184, Recruiting, SOLTI Breast Cancer Research Group | Active, not recruiting --> Recruiting | N=73 --> 184 | Trial completion date: Dec 2024 --> Mar 2027 | Trial primary completion date: Dec 2023 --> Sep 2025
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-1 (Programmed cell death 1)
    |
    PD-1 expression
    |
    Tevimbra (tislelizumab) • spartalizumab (PDR001)
    10ms
    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 2024 --> Sep 2025
    Trial completion date • Combination therapy
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    spartalizumab (PDR001) • sabatolimab (MBG453)
    11ms
    KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=145, Recruiting, Novartis Pharmaceuticals | Trial completion date: Aug 2024 --> Feb 2025 | Trial primary completion date: Aug 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    spartalizumab (PDR001) • KAZ954 • NZV930 • taminadenant (NIR178)
    11ms
    A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jul 2024 --> Nov 2023 | Trial primary completion date: Jul 2024 --> Nov 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab) • spartalizumab (PDR001) • NIZ985
    12ms
    Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS (clinicaltrials.gov)
    P1b, N=241, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: Apr 2023 --> Sep 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    azacitidine • decitabine • spartalizumab (PDR001) • sabatolimab (MBG453)
    12ms
    A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer (clinicaltrials.gov)
    P1, N=122, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=350 --> 122
    Enrollment closed • Enrollment change • Metastases
    |
    BRAF (B-raf proto-oncogene) • DUSP6 (Dual specificity phosphatase 6)
    |
    BRAF mutation • BRAF V600
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • Tevimbra (tislelizumab) • spartalizumab (PDR001) • naporafenib (ERAS-254) • batoprotafib (TNO155) • rineterkib (LTT462)
    12ms
    PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=30 --> 19
    Enrollment closed • Enrollment change • Combination therapy
    |
    BRAF V600E • BRAF V600 • BRAF V600K • BRAF V600D
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • spartalizumab (PDR001)
    1year
    A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands (clinicaltrials.gov)
    P1, N=185, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Nov 2023 --> Jun 2024
    Trial completion date
    |
    BRAF (B-raf proto-oncogene) • RNF43 (Ring Finger Protein 43)
    |
    BRAF mutation • RNF43 mutation
    |
    spartalizumab (PDR001) • WNT974
    1year
    A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2; Active, not recruiting --> Terminated; Sponsor decision
    Combination therapy • Trial termination • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8)
    |
    BRAF V600E • EGFR mutation • EGFR T790M • EGFR positive
    |
    VENTANA PD-L1 (SP142) Assay
    |
    spartalizumab (PDR001) • taminadenant (NIR178)
    1year
    A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer (clinicaltrials.gov)
    P1, N=350, Recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2024 --> Apr 2024 | Trial primary completion date: Oct 2024 --> Apr 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • DUSP6 (Dual specificity phosphatase 6)
    |
    BRAF mutation • BRAF V600
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • Tevimbra (tislelizumab) • spartalizumab (PDR001) • naporafenib (ERAS-254) • batoprotafib (TNO155) • rineterkib (LTT462)
    1year
    Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies (clinicaltrials.gov)
    P1, N=122, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=185 --> 122 | Trial completion date: Apr 2025 --> Oct 2023 | Trial primary completion date: Apr 2025 --> Oct 2023
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS G12C • EGFR wild-type • KRAS wild-type • RAS wild-type • KRAS G12 • EGFR wild-type + ALK wild-type
    |
    Kisqali (ribociclib) • spartalizumab (PDR001) • batoprotafib (TNO155)
    1year
    SPARC-1: A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P1, N=14, Recruiting, Columbia University | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    spartalizumab (PDR001) • Ilaris (canakinumab)
    1year
    Combined PD-1, BRAF and MEK inhibition in BRAF colorectal cancer: a phase 2 trial. (PubMed, Nat Med)
    We performed a proof-of-concept single-arm phase 2 clinical trial of combined PD-1, BRAF and MEK inhibition with sparatlizumab (PDR001), dabrafenib and trametinib in 37 patients with BRAF CRC. These data suggest a potential tumor cell-intrinsic mechanism of cooperativity between MAPK inhibition and immune response, warranting further clinical evaluation of optimized targeted and immune combinations in CRC. ClinicalTrials.gov registration: NCT03668431.
    P2 data • Clinical Trial,Phase II • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • spartalizumab (PDR001)
    1year
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; This was a sponsor decision and was not a consequence of any safety concern
    Trial termination • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    1year
    Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations (clinicaltrials.gov)
    P2, N=31, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Study termination based on sponsor decision due to lack of tolerability observed with capmatinib and spartalizumab combination treatment when compared to data from capmatinib single agent studies
    Trial termination • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement • EGFR wild-type
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001)