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Clinical trials for Spartalizumab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    13 result(s) found for: Spartalizumab. Displaying page 1 of 1.
    EudraCT Number: 2017-004865-28 Sponsor Protocol Number: CLAG525B2101 Start Date*: 2018-12-05
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase II open-label, randomized, three-arm, multicenter study of LAG525 given in combination with spartalizumab (PDR001), or with spartalizumab and carboplatin, or with carboplatin, as first or s...
    Medical condition: triple negative breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10072740 Locally advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) FR (Completed) DE (Completed) HU (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000349-14 Sponsor Protocol Number: CNIS793B12201 Start Date*: 2020-08-13
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase II, open label, randomized, parallel arm study of NIS793 (with and without spartalizumab) in combination with SOC chemotherapy gemcitabine/nab-paclitaxel, and gemcitabine/nab-paclitaxel alo...
    Medical condition: Pancreatic ductal adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10033604 Pancreatic cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) FR (Temporarily Halted) GB (GB - no longer in EU/EEA) AT (Prematurely Ended) BE (Completed) DE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003097-11 Sponsor Protocol Number: CINC280J12201 Start Date*: 2020-07-20
    Sponsor Name:Novartis Pharma AG
    Full Title: A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus capmatinib and placebo...
    Medical condition: non-small cell lung cancer with MET exon 14 skipping mutations
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10025048 Lung cancer non-small cell recurrent LLT
    20.0 100000004864 10025054 Lung cancer non-small cell stage IIIB LLT
    20.0 100000004864 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Prematurely Ended) BE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-002563-22 Sponsor Protocol Number: 2020/538 Start Date*: 2021-09-13
    Sponsor Name:CHU de Besançon
    Full Title: Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma. A Phase IIA study
    Medical condition: metastatic anal canal cancer
    Disease:
    Population Age: Gender:
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003022-22 Sponsor Protocol Number: SOLTI-1904 Start Date*: 2021-02-26
    Sponsor Name:SOLTI
    Full Title: EfficACy of Spartalizumab acROss multiPle cancer-types in patients with PD1-high mRNA expressing tumOrs defined by a singLe and pre-specIfied cutoff
    Medical condition: Metastatic disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001420-19 Sponsor Protocol Number: CINC280D2201 Start Date*: 2019-01-23
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase II, multicenter, randomized, two-arm study of capmatinib (INC280, an oral MET inhibitor) and spartalizumab (PDR001, a PD-1 inhibitor) combination therapy versus docetaxel in pretreated adul...
    Medical condition: Non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (Completed) BE (Completed) FR (Completed) GR (Completed) BG (Completed) NL (Completed) IT (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2021-001401-67 Sponsor Protocol Number: APHP201152 Start Date*: 2021-07-21
    Sponsor Name:ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (APHP)
    Full Title: Phase II trial to evaluate the combination of capmatinib + spartalizumab in advanced oesogastric adenocarcinoma
    Medical condition: Patients with advanced oesogastric adenocarcinoma that have received at least one previous chemotherapy line with platinium salt and fluoropyrimidin and with a documented progression.
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004864 10084873 Gastrooesophageal junction cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-004497-21 Sponsor Protocol Number: GASPAR Start Date*: 2021-01-20
    Sponsor Name:Centre François Baclesse
    Full Title: Perioperative Treatment in Resectable Gastric Cancer with Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT): A phase II study (GASPAR)
    Medical condition: Resectable gastric or gastroesophageal junction adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017758 Gastric cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000610-38 Sponsor Protocol Number: CPDR001J2201 Start Date*: 2018-10-19
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, open-label, phase II open platform study evaluating the efficacy and safety of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma
    Medical condition: Unresectable or metastatic melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Prematurely Ended) DE (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-004383-25 Sponsor Protocol Number: CDFF332A12101 Start Date*: 2021-10-22
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A Phase I/Ib, open-label, multi-center study of DFF332 as a single agent and in combination with Everolimus or IO agents in patients with advanced/relapsed ccRCC and other malignancies with HIF2alp...
    Medical condition: Advanced, relapsed Clear Cell Renal Cell Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10038396 Renal carcinoma recurrent LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004129-22 Sponsor Protocol Number: CJDQ443A12101 Start Date*: 2021-02-22
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation
    Medical condition: advanced solid tumors harboring the KRAS G12C mutation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned) DK (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-003929-17 Sponsor Protocol Number: CPDR001X2101 Start Date*: 2015-10-01
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Open label multicenter Phase I/II study of the safety and efficacy of PDR001 administered to patients with advanced malignancies
    Medical condition: Solid tumors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) FR (Completed) ES (Completed) HU (Completed) NO (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002794-35 Sponsor Protocol Number: CPDR001F2301 Start Date*: 2017-02-20
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, double-blind, placebo-controlled, phase III study comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated pati...
    Medical condition: Unresectable or metastatic BRAF V600 mutant melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) AT (Completed) CZ (Completed) PL (Completed) BG (Completed) GR (Completed) BE (Completed) PT (Completed) NL (Completed) DK (Completed) HU (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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