Drugs / Spartalizumab
last change Jul 2026 re-read 8 days ago

Spartalizumab

Monoclonal antibody targets PDCD1 via inhibition

Developed for
non-small cell lung carcinoma · colorectal cancer · melanoma · triple-negative breast carcinoma · cancer · hepatocellular carcinoma · esophageal squamous cell carcinoma · head and neck squamous cell carcinoma
+58 more · clear cell renal carcinoma · esophageal adenocarcinoma · gastric adenocarcinoma · malignant pancreatic neoplasm · pancreatic adenocarcinoma · chronic myelomonocytic leukemia · diffuse large B-cell lymphoma · gastrointestinal stromal tumor · lung cancer · malignant epithelial tumor of ovary · myelodysplastic syndrome · nasopharyngeal carcinoma · pancreatic ductal adenocarcinoma · prostate adenocarcinoma · renal cell carcinoma · small cell lung carcinoma · soft tissue sarcoma · squamous cell lung carcinoma · urothelial carcinoma · acute myeloid leukemia · anal carcinoma · breast cancer · cancer of unknown primary site · cervical carcinoma · cholangiocarcinoma · colorectal adenocarcinoma · cutaneous melanoma · endometrial carcinoma · gastric cancer · glioblastoma · head and neck cancer · HER2 positive breast carcinoma · hormone receptor-positive breast cancer · kidney cancer · lung adenocarcinoma · lymphoma · mesothelioma · metastatic malignant neoplasm · myelofibrosis · neuroendocrine carcinoma · non-functional pancreatic neuroendocrine tumor · ovarian adenocarcinoma · ovarian carcinoma · Parkinson disease · plasma cell myeloma · poorly differentiated thyroid gland carcinoma · premalignant hematological system disease · primary myelofibrosis · prostate cancer · refractory malignant neoplasm · sarcoma · thymic neuroendocrine tumor · thyroid gland carcinoma · thyroid gland follicular carcinoma · thyroid gland papillary carcinoma · thyroid gland undifferentiated (anaplastic) carcinoma · uterine carcinosarcoma · uveal melanoma
Investigated by
Novartis Pharmaceuticals · Novartis · Asan Medical Center · Pancreatic Cancer Action Network · Yonsei University · Assistance Publique - Hôpitaux de Paris
+21 more · Columbia University · Dana-Farber Cancer Institute · EUSA Pharma, Inc. · Emory University · Fondation ARC · H. Lee Moffitt Cancer Center and Research Institute · M.D. Anderson Cancer Center · Massachusetts General Hospital · Memorial Sloan Kettering Cancer Center · Muhammad Furqan · National Cancer Institute (NCI) · National Cancer Institute, France · National Institutes of Health (NIH) · National Taiwan University Hospital · Palobiofarma SL · Ruijin Hospital · SOLTI Breast Cancer Research Group · Seoul National University Hospital · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Stand Up To Cancer · University Hospital, Bordeaux

Trials 64 · started per year

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT04237649 Feb 2020 → Sep 2023 cancer Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 0 NCT04028245 Aug 2019 → Mar 2025 clear cell renal carcinoma Columbia University Completed No outcome recorded
Phase 131 trials
Phase 1 NCT07157345 Oct 2025 → Jan 2029 expected Parkinson disease Ruijin Hospital Recruiting No outcome recorded
Phase 1 NCT04895748 Nov 2021 → Feb 2026 clear cell renal carcinoma Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 1 NCT04283526 Nov 2020 → Apr 2024 myelofibrosis, primary myelofibrosis Novartis Pharmaceuticals Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT04581343 Nov 2020 → Nov 2022 pancreatic ductal adenocarcinoma Pancreatic Cancer Action Network Completed No outcome recorded
Phase 1 NCT04294160 Jul 2020 → Sep 2024 colorectal cancer Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 1 NCT04213404 Mar 2020 → Jan 2024 head and neck squamous cell carcinoma National Taiwan University Hospital Unknown No outcome recorded
Phase 1 NCT04261439 Feb 2020 → Dec 2023 melanoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1 NCT03961971 Feb 2020 → Nov 2022 glioblastoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 1 NCT04058756 Oct 2019 → Apr 2030 expected cancer Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 1 NCT03982134 Sep 2019 → May 2021 melanoma, non-small cell lung carcinoma Muhammad Furqan Withdrawn No outcome recorded Stop: Business
Phase 1/210 trials · 2 missed
Phase 1/2 NCT05210413 May 2022 → Aug 2025 overdue refractory malignant neoplasm University Hospital, Bordeaux Active not recruiting No outcome recorded
Phase 1/2 NCT04191421 Jan 2020 → Apr 2023 pancreatic adenocarcinoma Emory University Completed No outcome recorded
Phase 1/2 NCT03609424 Feb 2019 → Nov 2021 gastrointestinal stromal tumor Asan Medical Center Completed No outcome recorded
Phase 1/2 NCT02829723 Oct 2016 → Dec 2022 cancer Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1/2 NCT02807844 Jun 2016 → Jun 2020 endometrial carcinoma, melanoma, triple-negative breast carcinoma Novartis Pharmaceuticals Completed Missed primary
Phase 1/2 NCT02795429 Jun 2016 → Jun 2021 hepatocellular carcinoma Novartis Pharmaceuticals Completed Missed primary
Phase 1/2 NCT02608268 Nov 2015 → Aug 2022 cancer Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 1/2 NCT02460224 Jun 2015 → Dec 2020 cancer Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT02404441 Apr 2015 → Jul 2020 melanoma, non-small cell lung carcinoma, thyroid gland undifferentiated (anaplastic) carcinoma, triple-negative breast carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT02325739 Dec 2014 → May 2019 hepatocellular carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 219 trials · 1 met primary · 2 missed
Phase 2 NCT05201066 Feb 2023 → Feb 2028 expected chronic myelomonocytic leukemia, myelodysplastic syndrome Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 2 NCT05135845 Mar 2022 → Apr 2023 esophageal adenocarcinoma, gastric adenocarcinoma Assistance Publique - Hôpitaux de Paris Suspended No outcome recorded Stop: Business
Phase 2 NCT04802876 Apr 2021 → Sep 2025 overdue HER2 positive breast carcinoma, anal carcinoma, cancer of unknown primary site, cervical carcinoma +21 SOLTI Breast Cancer Research Group Active not recruiting No outcome recorded
Phase 2 NCT04390763 Oct 2020 → Apr 2024 pancreatic ductal adenocarcinoma Novartis Pharmaceuticals Terminated Missed primary
Phase 2 NCT04544111 Sep 2020 → Sep 2027 expected poorly differentiated thyroid gland carcinoma, thyroid gland follicular carcinoma, thyroid gland papillary carcinoma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT04323436 Aug 2020 → Dec 2022 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 2 NCT03785496 Feb 2020 → Jan 2022 esophageal squamous cell carcinoma Yonsei University Unknown No outcome recorded
Phase 2 NCT04310397 Jan 2020 → Oct 2023 cutaneous melanoma M.D. Anderson Cancer Center Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03945227 Jun 2019 → Jan 2022 non-small cell lung carcinoma Yonsei University Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT03694977 Jan → Dec 2019 gastric cancer Seoul National University Hospital Unknown No outcome recorded
Phase 32 trials · 1 missed
Phase 3 NCT04229004 Jan 2020 → Feb 2025 pancreatic adenocarcinoma Pancreatic Cancer Action Network Completed No outcome recorded
Phase 3 NCT02967692 Feb 2017 → Aug 2020 melanoma Novartis Pharmaceuticals Terminated Missed primary Stop: Business
Comparator or background therapy1 trial
Phase 1 NCT03172936 Background Sep 2017 → Dec 2020 lymphoma Novartis Pharmaceuticals Terminated No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2020-09-19 Novartis Pharmaceuticals Results Novartis reports late-breaking data from Phase III COMBI-i trial of spartalizumab (PDR001) with Tafinlar® and Mekinist® in advanced melanoma novartis.com ↗
The trial did not meet its primary endpoint of investigator-assessed progression-free survival (PFS) for patients treated with the investigational triplet therapy 1-4 .
2020-08-22 Novartis Pharmaceuticals Results Novartis provides update on Phase III study evaluating investigational spartalizumab (PDR001) in combination with Tafinlar® + Mekinist® in advanced melanoma novartis.com ↗
Novartis announced today that the Phase III COMBI-i study evaluating the investigational immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar ® (dabrafenib) and Mekinist ® (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival.

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 71 sources stand behind the page.

FieldValueCited text
Known as spartalizumab “This study was a first in human (FIH), open-label, Phase I-Ib/II, multi-center study which consisted of a Phase I dose escalation part of sabatolimab (MBG453) as single agent,...” NCT02608268 ↗
28

“spartalizumab (PDR001), a high-affinity, ligand-blocking, humanized anti-PD-1 immunoglobulin G4 antibody, with lacnotuzumab (MCS110), a high-affinity, humanized monoclonal...” PMID 38721402 ↗ May 2024

“Phase I Study of Taminadenant (PBF509/NIR178), an Adenosine 2A Receptor Antagonist, with or without Spartalizumab (PDR001), in Patients with Advanced Non-Small Cell Lung Cancer.” PMID 35254415 ↗ Jun 2022

“A first-in-human phase 1 dose escalation study of spartalizumab (PDR001), an anti-PD-1 antibody, in patients with advanced solid tumors.” PMID 32179633 ↗ Mar 2020

“Phase I/II study of the LAG-3 inhibitor ieramilimab (LAG525) ± anti-PD-1 spartalizumab (PDR001) in patients with advanced malignancies.” PMID 35217575 ↗ Feb 2022

“Monoclonal antibodies, such as MBG453 and spartalizumab may interfere with the ability of tumor cells to grow and spread.” NCT03961971 ↗

“Spartalizumab (PDR001) is a humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).” PMID 38919826 ↗ Jun 2024

NCT02795429 ↗

NCT03647488 ↗

NCT04294160 ↗

NCT04028245 ↗

Show 18 more sources

Known as ANTI-PD1 MONOCLONAL ANTIBODY PDR001 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297831 ↗
Known as Espartalizumab ChEMBL registry synonym — accepted as the source's own label CHEMBL4297831 ↗
Known as NVP-LZV184 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297831 ↗
Known as PDR-001 “PDR001 (also referred to as spartalizumab) is a humanized monoclonal antibody (mAb) directed against human programmed death-1 (PD-1) that blocks the interaction between PD-1...” NCT05210413 ↗
44

“This study combines canakinumab (ACZ885), a high-affinity human anti-interleukin-1β (IL-1β) monoclonal antibody (mAb), and spartalizumab (PDR001), a mAb directed against human...” NCT04581343 ↗

“Phase I Study of Taminadenant (PBF509/NIR178), an Adenosine 2A Receptor Antagonist, with or without Spartalizumab (PDR001), in Patients with Advanced Non-Small Cell Lung Cancer.” PMID 35254415 ↗ Jun 2022

“Our prior work identified tat-βsyn-deg (PDR-001), a three-segment peptide that selectively targets α-synuclein.” NCT07157345 ↗

NCT02404441 ↗

NCT03785496 ↗

NCT07157345 ↗

NCT04544111 ↗

NCT02608268 ↗

NCT02460224 ↗

NCT04237649 ↗

Show 34 more sources

Known as sparatlizumab “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...” PMID 36702949 ↗ Jan 2023
Known as Spartalizumab/PDR001 “Spartalizumab/PDR001” NCT02900664 ↗
Known as tat-βsyn-deg “Our prior work identified tat-βsyn-deg (PDR-001), a three-segment peptide that selectively targets α-synuclein.” NCT07157345 ↗
Action Inhibit “PDR001 is a humanized anti-PD1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2” NCT02325739 ↗
Modality Monoclonal antibody “PDR001 is a humanized anti-PD1 IgG4 antibody” NCT02325739 ↗
Route Intravenous “Intravenous PDR001 was administered in a fixed dosing regimen of 300 mg iv every three weeks” NCT02325739 ↗
Target PDCD1 “anti-PD-1 spartalizumab (PDR001)” PMID 35217575 ↗ Feb 2022