spartalizumab (PDR001) / Novartis  >>  Phase 2
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32 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
spartalizumab (PDR001) / Novartis
NCT02955069 / 2016-002522-36: Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)

Completed
2
116
Europe, Canada, Japan, US, RoW
PDR001, Spartalizumab
Novartis Pharmaceuticals
Well-differentiated Non-functional NET of Thoracic Origin, Well-differentiated Non-functional NET of Gastrointestinal Origin, Well-differentiated Non-functional NET of Pancreatic Origin, Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma
08/18
05/20
NCT03365791: PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies

Checkmark Completion of P2 study for solid and hematologic malignancies
Feb 2019 - Feb 2019: Completion of P2 study for solid and hematologic malignancies
Completed
2
76
US
PDR001, LAG525
Novartis Pharmaceuticals
Small Cell Lung Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Castration Resistant Prostate Adenocarcinoma, Soft Tissue Sarcoma, Ovarian Adenocarcinoma, Advanced Well-differentiated Neuroendocrine Tumors, Diffuse Large B Cell Lymphoma
02/19
09/20
NCT02605967 / 2015-000454-38: Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Completed
2
122
Europe, US, RoW
Spartalizumab, PDR001, Investigator choice of chemotherapy
Novartis Pharmaceuticals
Nasopharyngeal Carcinoma
11/19
02/21
NCT03694977: Biomarker Study of PDR001 in Combination With MCS110 in Gastric Cancer

Unknown status
2
30
RoW
MCS110/PDR001 combination
Seoul National University Hospital
Gastric Cancer
12/19
12/19
NCT03499899 / 2017-004865-28: A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer

Completed
2
88
Europe, Canada, Japan, US, RoW
LAG525, PDR001, Spartalizumab, Carboplatin
Novartis Pharmaceuticals
Triple-negative Breast Cancer
02/20
11/21
NCT03693326: PDR001 in Patients With Non-small Cell Lung Cancer Harboring KRAS/NRAS Mutation or no Actionable Genetic Abnormalities

Unknown status
2
70
RoW
PDR001
Asan Medical Center
Cancer, Lung Cancer Metastatic, Immunotherapy
06/20
06/22
NCT03647488 / 2018-001420-19: Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer

Completed
2
18
Europe, US, RoW
Capmatinib, INC280, Spartalizumab, PDR001, Docetaxel
Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
09/20
09/20
2020-003022-22: SOLTI-1904: EfficACy of Spartalizumab acROss multiPle cancer-types in patients with PD1-high mRNA expressing tumOrs defined by a singLe and pre-specIfied cutoff (ACROPOLI trial) SOLTI-1904: Eficacia de spartalizumab en múltiples tipos de cáncer en pacientes con tumores con expresión elevada de ARNm de PD1, definida según un punto de corte preespecificado (ensayo ACROPOLI)

Not yet recruiting
2
141
Europe
Spartalizumab, PDR001, Concentrate for solution for infusion
SOLTI, Novartis Pharma AG
Metastatic disease Enfermedad metastásica, Metastatic disease Enfermedad metastásica, Diseases [C] - Cancer [C04]
 
 
NCT03945227: Clinical Trial for Evaluating Efficacy and Safety of PDR001 in Concurrent Plus Consolidation Versus Consolidation Only in Addition to Standard Chemoradiotherapy in Unresectable Stage III NSCLC Patients (PASTURE)

Withdrawn
2
0
RoW
standard platinum-based concurrent chemoradiotherapy, followed by consolidation with PDR001, PDR001 concurrent with standard platinum-based chemoradiation, followed by consolidation with PDR001
Yonsei University
Stage III NSCLC
01/22
01/22
NCT03785496: Study to Evaluate Efficacy of PDR001 in Patients With Squamous Cell Carcinoma of the Esophagus

Active, not recruiting
2
44
RoW
PDR001
Yonsei University
Histologically Confirmed Unresectable or Metastatic Squamous Cell Carcinoma of the Esophagus Who Failed on Standard Treatment
01/22
01/24
NCT03668431: Dabrafenib + Trametinib + PDR001 In Colorectal Cancer

Recruiting
2
25
US
Dabrafenib, Tafinlar®, Trametinib, Mekinist®, PDR001
Massachusetts General Hospital, Novartis, Stand Up To Cancer
Metastatic Colorectal Cancer
09/22
12/22
NCT04323436 / 2019-003097-11: Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations

Terminated
2
31
Europe, Canada, Japan, US, RoW
Spartalizumab, PDR001, Capmatinib, INC280, spartalizumab placebo, PDR001 placebo
Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
12/22
01/23
PLATforM, NCT03484923 / 2018-000610-38: Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

Calendar Jan 2024 - Dec 2024: Final data from P2 PLATforM trial for metastatic melanoma
Hourglass Jan 2022 - Dec 2022 : Data from PLATforM trial for metastatic melanoma
Completed
2
196
Europe, Canada, US, RoW
PDR001, Spartalizumab, LAG525, Ieramilimab, INC280, Capmatinib, ACZ885, Canakinumab, LEE011, Ribociclib
Novartis Pharmaceuticals
Melanoma
12/22
12/22
CNIR178X2201, NCT03207867 / 2017-000241-49: A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

Terminated
2
315
Europe, Japan, US, RoW
NIR178, taminadenant, PDR001, spartalizumab
Novartis Pharmaceuticals
NSCLC, Non Small Cell Lung Cancer, RCC, Renal Cell Cancer, Pancreatic Cancer, Urothelial Cancer, Head and Neck Cancer, DLBCL, Diffused Large B Cell Lymphoma, MSS, Microsatellite Stable Colon Cancer, TNBC, Triple Negative Breast Cancer, Melanoma, mCRPC, Metastatic Castration Resistant Prostate Cancer
02/23
02/23
METIMGAST, NCT05135845: Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma

Suspended
2
90
Europe
Capmatinib, INC280, Spartalizumab, PDR001
Assistance Publique - Hôpitaux de Paris
Oesophageal Adenocarcinoma, Gastric Adenocarcinoma
04/23
10/25
ALTER-PATH NeoDT, NCT04310397: Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma

Completed
2
4
US
Dabrafenib, BRAF Inhibitor GSK2118436, GSK-2118436, GSK-2118436A, GSK2118436, Spartalizumab, PDR-001, PDR001, Therapeutic Conventional Surgery, Trametinib, GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Mekinist
M.D. Anderson Cancer Center
Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8
10/23
10/23
SPARTANA, NCT04894370: Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma

Recruiting
2
34
Europe
Sample collection
Centre Hospitalier Universitaire de Besancon, National Cancer Institute, France, Novartis
Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
06/25
11/26
GASPAR, NCT04736485 / 2020-004497-21: Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT)

Active, not recruiting
2
67
Europe
perioperative treatment
Centre Francois Baclesse, National Cancer Institute, France
Gastric Cancer by AJCC V8 Stage, Resectable Carcinoma
03/24
03/27
daNIS-1, NCT04390763 / 2020-000349-14: Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Terminated
2
164
Europe, US, RoW
NIS793, Spartalizumab, PDR001, gemcitabine, nab-paclitaxel, abraxane
Novartis Pharmaceuticals
Metastatic Pancreatic Ductal Adenocarcinoma
04/24
05/24
NCT04544111: PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer

Active, not recruiting
2
19
US
Trametinib, Dabrafenib, PDR001
Memorial Sloan Kettering Cancer Center
Thyroid Cancer, Thyroid Cancer, Follicular, Papillary Thyroid Cancer, Follicular Thyroid Cancer, Hurthle Cell Tumor, Poorly Differentiated Thyroid Gland Carcinoma, Hurthle Cell Thyroid Neoplasia
09/25
09/25
ACROPOLI, NCT04802876: Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors

Recruiting
2
184
Europe
Spartalizumab, PDR001, Tislelizumab
SOLTI Breast Cancer Research Group, Novartis
MSI-H Colorectal Cancer, Melanoma, Anal Carcinoma, Mesothelioma, Triple Negative Breast Cancer, Lung Adenocarcinoma, Cholangiocarcinoma, Cervical Carcinoma, Kidney Clear Cell Carcinoma, Stomach Adenocarcinoma, Esophageal Adenocarcinoma, Uterine Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Sarcoma, Lung Squamous Cell Carcinoma, Urothelial Carcinoma, Thyroid Carcinoma, Hepatocellular Carcinoma, Uveal Melanoma, HER2-positive Breast Cancer, Pancreatic Adenocarcinoma, Squamous Esophageal Carcinoma, Epithelial Ovarian Cancer, Uterine Carcinosarcoma, Small Cell Lung Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, Lung Adenocarcinoma EGFR-mutated/ ALK Traslocation, Colorectal Adenocarcinoma, Prostate Adenocarcinoma, Carcinoma of Unknown Primary, Other Histology
09/25
03/27
NCT05201066: Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.

Recruiting
2
70
Europe, US, RoW
decitabine, spartalizumab, PDR001, sabatolimab, MBG453, azacitidine, venetoclax, INQOVI (oral decitabine)
Novartis Pharmaceuticals
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
09/27
02/28
NCT02325739 / 2014-002929-35: FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression

Completed
1/2
172
Europe, Japan, US, RoW
FGF401, PDR001
Novartis Pharmaceuticals
Hepatocellular Carcinoma (HCC), Solid Malignancies
05/19
05/19
NCT02807844 / 2016-000210-29: Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

Completed
1/2
141
Europe, Japan, US, RoW
MCS110, colony-stimulating factor-1 [CSF-1]), PDR001
Novartis Pharmaceuticals
Triple Negative Breast Cancer, Pancreatic Carcinoma, Melanoma, Endometrial Carcinoma
06/20
06/20
NCT02404441 / 2014-003929-17: Phase I/II Study of PDR001 in Patients With Advanced Malignancies

Checkmark ASCO 2016
May 2016 - May 2016: ASCO 2016
Completed
1/2
319
Europe, Canada, US, RoW
PDR001
Novartis Pharmaceuticals
Melanoma, Non-small Sell Lung Cancer (NSCLC), Triple Negative Breast Cancer, Anaplastic Thyroid Cancer, Other Solid Tumors
07/20
07/20
NCT02460224 / 2015-000449-21: Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.

Checkmark Update from trial of LAG525 monotherapy and in combination with PDR001 for advanced malignancies
Jun 2018 - Jun 2018: Update from trial of LAG525 monotherapy and in combination with PDR001 for advanced malignancies
Completed
1/2
490
Europe, Canada, Japan, US, RoW
LAG525, PDR001
Novartis Pharmaceuticals
Advanced Solid Tumors
12/20
12/20
NCT02795429 / 2015-005417-76: Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC

Completed
1/2
89
Europe, Canada, RoW
Spartalizumab, PDR001, Capmatinib, INC280
Novartis Pharmaceuticals
Advanced Hepatocellular Carcinoma
06/21
06/21
NCT03609424: PDR001 Plus Imatinib for Metastatic or Unresectable GIST

Completed
1/2
39
RoW
PDR001, Imatinib
Asan Medical Center, Novartis
Gastrointestinal Stromal Tumors
11/21
11/21
NCT02608268 / 2015-002354-12: Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

Checkmark In combination with PDR001 in patients with advanced malignancies
Nov 2015 - Nov 2015: In combination with PDR001 in patients with advanced malignancies
Checkmark Initiation of clinical trial in combination with MBG453 for solid tumors
Oct 2015 - Oct 2015: Initiation of clinical trial in combination with MBG453 for solid tumors
Terminated
1/2
252
Europe, Canada, Japan, US, RoW
MBG453, sabatolimab, PDR001, spartalizumab, Decitabine
Novartis Pharmaceuticals
Advanced Malignancies
08/22
08/22
NCT02829723 / 2015-005806-12: A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors

Terminated
1/2
192
Europe, Japan, US, RoW
BLZ945, PDR001, spartalizumab
Novartis Pharmaceuticals
Advanced Solid Tumors
12/22
12/22
NCT04191421: Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer

Completed
1/2
42
US
Siltuximab, Anti-IL-6 Chimeric Monoclonal Antibody, cCLB8, CNTO 328, Sylvant, Spartalizumab, PDR001
Emory University, Novartis, EUSA Pharma, Inc., National Cancer Institute (NCI), National Institutes of Health (NIH)
Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
04/23
04/23
SPARTO, NCT05210413: Spartalizumab and Low-dose PAzopanib in Refractory or Relapsed Solid TumOrs of Pediatric and Adults

Recruiting
1/2
59
Europe
Spartalizumab in Pediatric cohort, Low-dose Pazopanib in Pediatric Cohort, Spartalizumab in Adult cohort, Low-dose Pazopanib in Adult Cohort
University Hospital, Bordeaux, National Cancer Institute, France, Fondation ARC, Novartis
Refractory or Recurrent Solid Tumor
11/26
11/27

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