spartalizumab (PDR001) / Novartis  >>  Phase 1
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34 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
spartalizumab (PDR001) / Novartis
PanCAN-SR1, NCT04581343: A Phase 1B Study of Canakinumab, Spartalizumab, Nab-paclitaxel, and Gemcitabine in Metastatic PC Patients

Checkmark Results from PanCAN-SR1 trial for metastatic pancreatic ductal adenocarcinoma
Nov 2022 - Nov 2022: Results from PanCAN-SR1 trial for metastatic pancreatic ductal adenocarcinoma
Active, not recruiting
1b
10
US
Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine, Ilaris, Abraxane
Pancreatic Cancer Action Network, Novartis Pharmaceuticals
Metastatic Pancreatic Ductal Adenocarcinoma
03/23
08/23
CPDR001X2105, NCT03066648: Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

Checkmark Data from P1b portion of trial in combination with MBG453 and decitabine for AML/MDS at EHA 2020
Jun 2020 - Jun 2020: Data from P1b portion of trial in combination with MBG453 and decitabine for AML/MDS at EHA 2020
Checkmark In combination with PDR001 for AML or high risk MDS
Feb 2017 - Feb 2017: In combination with PDR001 for AML or high risk MDS
Completed
1b
241
Europe, US, RoW
Decitabine, 5-aza-2'-deoxycytidine, PDR001, spartalizumab, MBG453, sabatolimab, Azacitidine, 5-azacytidine
Novartis Pharmaceuticals
Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Preleukemia, Bone Marrow Diseases, Hematologic Diseases, Chronic Myelomonocytic Leukemia
09/23
09/23
NCT02678260: Phase I Study of PDR001 in Patients With Advanced Malignancies.

Completed
1
18
Japan
PDR001
Novartis Pharmaceuticals
Advanced Malignancies
09/17
09/17
NCT03176264: PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

Checkmark First patient first visit in clinical trial of PDR001 + bevacizumab + mFOLFOX6 in 1LCRC
Oct 2017 - Oct 2017: First patient first visit in clinical trial of PDR001 + bevacizumab + mFOLFOX6 in 1LCRC
Terminated
1
1
Europe
PDR001, bevacizumab, mFOLFOX6
Novartis Pharmaceuticals
Metastatic Colorectal Cancer
01/18
01/18
NCT03081494: Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Completed
1
10
Europe, Canada, RoW
spartalizumab (PDR001), PDR001, regorafenib
Novartis Pharmaceuticals
Metastatic Colorectal Cancer
05/19
05/19
NCT02988440: Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients

Completed
1
20
Europe, Canada, Japan, US, RoW
PDR001, Sorafenib
Novartis Pharmaceuticals
Hepatocellular Carcinoma
02/20
02/20
NCT03111992: Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Multiple Myeloma

Completed
1
26
Europe, US
PDR001, CJM112, LCL161
Novartis Pharmaceuticals
Multiple Myeloma
03/20
03/20
NCT02740270 / 2015-004206-42: Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas

Completed
1
92
Europe, Canada, Japan, US, RoW
GWN323, PDR001
Novartis Pharmaceuticals
Solid Tumors, Lymphomas
03/20
03/20
NCT03294694: Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer

Terminated
1
33
US
Ribociclib, Kisqali, LEE011, LEE-011, PDR001, Fulvestrant, Faslodex, ICI 182,780, ZD9238
Dana-Farber Cancer Institute, Novartis
Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer, Metastatic Epithelial Ovarian Cancer
10/20
10/20
NCT03172936: Study of the Safety and Efficacy of MIW815 With PDR001 in Patients With Advanced/Metastatic Solid Tumors or Lymphomas

Hourglass Jul 2020 - Dec 2020 : Dose escalation data in combination with sparatlizumab for solid tumors and lymphomas
Checkmark Data from P1 trial in combination with spartalizumab in solid tumor and lymphoma at ASCO 2019 [screenshot]
Jun 2019 - Jun 2019: Data from P1 trial in combination with spartalizumab in solid tumor and lymphoma at ASCO 2019 [screenshot]
Checkmark Preliminary data from P1b trial in combination with PDR001
Nov 2018 - Nov 2018: Preliminary data from P1b trial in combination with PDR001
Terminated
1
106
Europe, Canada, Japan, US, RoW
MIW815, PDR001
Novartis Pharmaceuticals
Solid Tumors and Lymphomas
12/20
12/20
NCT02900664: A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

Completed
1
283
Europe, Canada, US, RoW
PDR001, Spartalizumab/PDR001, ACZ885, canakinumab, CJM112, TMT212, trametinib, EGF816, Nazartinib
Novartis Pharmaceuticals
Colorectal Cancer, Triple Negative Breast Cancer, NSCLC - Adenocarcinoma
03/21
03/21
NCT03982134: PDR001 + Panobinostat for Melanoma and NSCLC

Withdrawn
1
0
NA
PDR001, spartalizumab, Panobinostat, LBH589 lactate
Muhammad Furqan, Novartis Pharmaceuticals
Melanoma, Non Small Cell Lung Cancer
05/21
05/22
NCT01351103: A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands

Active, not recruiting
1
185
Europe, Canada, US
LGK974, WNT974, PDR001
Novartis Pharmaceuticals
Pancreatic Cancer, BRAF Mutant Colorectal Cancer, Melanoma, Triple Negative Breast Cancer, Head and Neck Squamous Cell Cancer, Cervical Squamous Cell Cancer, Esophageal Squamous Cell Cancer, Lung Squamous Cell Cancer
06/21
06/24
NCT02947165: Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.

Completed
1
120
Europe, Canada, Japan, US, RoW
NIS793, PDR001
Novartis Pharmaceuticals
Breast Cancer, Lung Cancer, Hepatocellular Cancer, Colorectal Cancer, Pancreatic Cancer, Renal Cancer
06/21
06/21
NCT03064854: PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients

Terminated
1
111
Europe, Canada, US, RoW
PDR001, Cisplatin, Gemcitabine, Pemetrexed, Carboplatin, Paclitaxel, Canakinumab
Novartis Pharmaceuticals
Non-small Cell Lung Cancer
07/21
07/21
AdenONCO, NCT02403193: Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Completed
1
92
US
PBF-509_80 mg, PBF-509_160 mg, PBF-509_320 mg, PBF-509_640 mg, Combo PBF-509 (160 mg) + PDR001, Combo PBF-509 (320 mg) + PDR001, Combo PBF-509 (640 mg) + PDR001, RP2D (PBF-509+PDR001)_immuno naïve, Experimental: RP2D (PBF-509+PDR001)_immuno treated
Palobiofarma SL, Novartis, H. Lee Moffitt Cancer Center and Research Institute
Non-small Cell Lung Cancer (NSCLC)
10/21
11/21
NCT02607813: Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations

Terminated
1
142
Europe, Canada, Japan, US, RoW
LXH254, PDR001
Novartis Pharmaceuticals
NSCLC, Ovarian Cancer, Melanoma, Other Solid Tumors
02/22
02/22
NCT02890069: A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

Completed
1
298
Europe, US, RoW
PDR001, LCL161, Everolimus, RAD001, Panobinostat, LBH589, QBM076, HDM201
Novartis Pharmaceuticals
Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma
02/22
02/22
NCT02452268: A Phase I/Ib Study of NIZ985 in Combination With PDR001 in Adults With Metastatic Cancers

Terminated
1
83
US
NIZ985, IL-15/sIL-15Ra, heterodimeric IL-15, PDR001
Novartis Pharmaceuticals
Metastatic and Advanced Solid Tumors
03/22
03/22
NCT03301896: Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

Terminated
1
45
Europe, Japan, US, RoW
LHC165, PDR001
Novartis Pharmaceuticals
Solid Tumors
06/22
06/22
NCT03549000: A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.

Terminated
1
127
Europe, Canada, Japan, US, RoW
NZV930, Biological, PDR001, NIR178
Novartis Pharmaceuticals
Non-small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer Microsatellite Stable (MSS), Ovarian Cancer, Renal Cell Carcinoma (RCC), Metastatic Castration Resistant Prostate Cancer (mCRPC)
10/22
10/22
NCT03961971: Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM

Active, not recruiting
1
16
US
MBG453, spartalizumab, stereotactic radiosurgery
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Novartis Pharmaceuticals
Glioblastoma Multiforme
11/22
09/25
NCT03742349: Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).

Terminated
1
64
Europe, Japan, US, RoW
spartalizumab, PDR001, LAG525, NIR178, capmatinib, INC280, MCS110, canakinumab, ACZ885
Novartis Pharmaceuticals
Triple Negative Breast Cancer (TNBC)
02/23
02/23
NCT04237649: KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors

Terminated
1
77
Europe, Canada, Japan, US, RoW
KAZ954, PDR001, NIR178, NZV930
Novartis Pharmaceuticals
Solid Tumors
09/23
09/23
NCT04261439: A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab

Terminated
1
60
Europe, Japan, US, RoW
NIZ985, Spartalizumab, PDR001, Tislelizumab, VDT482
Novartis Pharmaceuticals
In Escalation: All Patients With Solid Tumors and Lymphoma, In Expansion: Melanoma, Non-small Cell Lung Cancer
12/23
12/23
NCT04000529: Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

Terminated
1
122
Europe, Japan, US, RoW
TNO155, Spartalizumab, PDR001, Ribociclib, LEE011
Novartis Pharmaceuticals
Non-small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal SCC, Gastrointestinal Stromal Tumors, Colorectal Cancer
01/24
01/24
RISE-HN, NCT04213404: Ribociclib and Spartalizumab in R/M HNSCC

Active, not recruiting
1
13
RoW
Ribociclib, Kisqali, Spartalizumab, PDR001
National Taiwan University Hospital, Novartis
Head and Neck Squamous Cell Carcinoma
01/24
01/25
NCT04283526: Study of Select Combinations in Adults With Myelofibrosis

Withdrawn
1
0
NA
MBG453, NIS793, Spartalizumab, PDR001, Decitabine, Dacogen
Novartis Pharmaceuticals
Primary Myelofibrosis, Myelofibrosis, PMF, Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis
04/24
04/24
NCT03891953: Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.

Active, not recruiting
1
98
Europe, Japan, US, RoW
DKY709, PDR001, Spartalizumab
Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung, Melanoma, Nasopharyngeal Carcinoma, Microsatellite Stable Colorectal Cancer, Triple Negative Breast Cancer
09/24
09/24
NCT04294160: A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

Active, not recruiting
1
122
Europe, Canada, US, RoW
Dabrafenib, DRB436, Tafinlar, LTT462, Trametinib, TMT212, Mekinist, LXH254, TNO155, Spartalizumab, PDR001, Tislelizumab, VDT482, BGBA317
Novartis Pharmaceuticals
BRAF V600 Colorectal Cancer
10/24
10/24
NCT02936102: A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.

Active, not recruiting
1
154
Europe, Canada, Japan, US, RoW
FAZ053, PDR001
Novartis Pharmaceuticals
Advanced Solid Tumors, Triple Negative Breast Cancer, Chordoma and Alveolar Soft Part Sarcoma
11/24
11/24
CDFF332A12101, NCT04895748 / 2020-004383-25: DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies

Active, not recruiting
1
40
Europe, Japan, US, RoW
DFF332, RAD001, Everolimus, PDR001, Spartalizumab, NIR178, Taminadenant
Novartis Pharmaceuticals
Carcinoma, Renal Cell
02/25
02/25
SPARC-1, NCT04028245: A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma

Recruiting
1
14
US
Spartalizumab, PDR-001, Canakinumab, ACZ885
Columbia University, Novartis
Carcinoma, Renal Cell
12/25
12/26
NCT04058756: Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

Active, not recruiting
1
120
Europe, Canada, US, RoW
PDR001
Novartis Pharmaceuticals
Advanced Solid Tumors
04/30
04/30

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