Drugs / Dostarlimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Jemperli | — | 2021-04-21 | europa.eu ↗ |
Trials 94 · started per year
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EU approved 2021
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT06551142 | Sep 2024 → Oct 2028 expected | neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1 | NCT05980416 | Aug 2023 → May 2025 | gastric neoplasm | Elevation Oncology | Terminated | No outcome recorded |
| Phase 1 | NCT05819892 | Jul 2023 → Mar 2027 expected | endometrial cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05646082 | May 2023 → Jul 2026 overdue | Kaposi's sarcoma | Imperial College London | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04926324 | Jul 2022 → Nov 2024 | rectal cancer | University of Iowa | Terminated | No outcome recorded |
| Phase 1 | NCT05277051 | Mar 2022 → Aug 2027 expected | neoplasm | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04673448 | Oct 2021 → Dec 2025 overdue | fallopian tube carcinoma, female breast carcinoma, hereditary breast carcinoma, hereditary neoplastic syndrome +4 | University of Washington | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04544995 | Oct 2020 → Apr 2025 | neoplasm | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1 | NCT04446351 | Jun 2020 → Dec 2026 expected | neoplasm | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03955978 | Oct 2019 → Mar 2024 overdue | endometrial cancer | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03307785 | Oct 2017 → Feb 2020 | metastatic malignant neoplasm, non-small cell lung carcinoma | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03250832 | Aug 2017 → Jun 2022 | neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02723955 | Jun 2016 → Jul 2023 | neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02715284 | Mar 2016 → May 2026 overdue | neoplasm | Tesaro, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/211 trials | ||||||
| Phase 1/2 | NCT06405230 | Dec 2025 → Aug 2028 expected | non-small cell lung carcinoma | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06879717 | Apr 2025 → Jan 2027 expected | non-small cell lung carcinoma | iOnctura | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06521567 | Mar 2025 → Oct 2026 expected | Hodgkins lymphoma, diffuse intrinsic pontine glioma, ependymoma, fibrolamellar hepatocellular carcinoma +5 | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06796907 | Mar 2025 → Jun 2027 expected | female reproductive system neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06385548 | May 2024 | endometrial cancer | Vall d'Hebron Institute of Oncology | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05784012 | Nov 2023 → Mar 2027 expected | head and neck squamous cell carcinoma | Spanish Head And Neck Cancer Cooperative Group | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06065462 | Nov 2023 → Oct 2027 expected | ovarian clear cell cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05559879 | Aug 2023 → Apr 2027 expected | carcinoma, endometrial cancer | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05060432 | Sep 2021 → Jul 2024 | cancer of unknown primary site, head and neck cancer, lung neoplasm, melanoma | iTeos Therapeutics | Unknown | No outcome recorded |
| Phase 1/2 | NCT06655818 | Mar 2021 → Feb 2024 | refractory plasma cell neoplasm | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1/2 | NCT04126200 | Oct 2019 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 258 trials | ||||||
| Phase 2 | NCT07408063 | Apr 2026 → Jun 2030 expected | head and neck squamous cell carcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT07381777 | Jan 2026 → Jul 2028 expected | rectal cancer | Italian Oncology Group for Clinical Research | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07336147 | Dec 2025 → Dec 2027 expected | — | Chang Gung Memorial Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07224971 | Dec 2025 → May 2027 expected | non-small cell lung carcinoma | Liza Villaruz, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT07108270 | Nov 2025 → Mar 2030 expected | endometrial cancer | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT07013851 | Oct 2025 → Mar 2029 expected | reproductive system cancer | Spanish Ovarian Cancer Research Group | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07115927 | Sep 2025 → Apr 2030 expected | endometrial cancer | University College, London | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06830239 | Apr 2025 → Dec 2027 expected | malignant colon neoplasm | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 2 | NCT06567782 | Feb 2025 → Nov 2026 expected | colorectal cancer | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT06757244 | Feb 2025 → Feb 2028 expected | pancreatic neoplasm | Hopital Foch | Recruiting | No outcome recorded |
| Phase 2 | NCT06365970 | Jan 2025 → Jan 2027 | colorectal cancer | Ibrahim Halil Sahin | Withdrawn | No outcome recorded |
| Phase 2 | NCT06640049 | Oct 2024 → Oct 2027 expected | rectal cancer | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06278857 | Aug 2024 → Jun 2026 overdue | endometrial endometrioid adenocarcinoma, uterine carcinoma | Queensland Centre for Gynaecological Cancer | Recruiting | No outcome recorded |
| Phase 2 | NCT06333314 | Jul 2024 → Oct 2028 expected | adrenal cortex carcinoma, carcinoma of the ampulla of vater, duodenal adenocarcinoma, gastric adenocarcinoma +3 | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT06317311 | May 2024 → Jul 2026 overdue | carcinoma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06238635 | Mar 2024 → Dec 2026 expected | cervical carcinoma | Meghan Shea | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04274023 | Jan 2024 | clear cell sarcoma | Italian Sarcoma Group | Terminated | No outcome recorded |
| Phase 2 | NCT06023862 | Jan 2024 → Aug 2027 expected | carcinoma, endometrium neoplasm, ovarian neoplasm, uterine cervix neoplasm +2 | Yonsei University | Recruiting | No outcome recorded |
| Phase 2 | NCT06059495 | Dec 2023 → Sep 2028 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | GERCOR - Multidisciplinary Oncology Cooperative Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06062420 | Nov 2023 → Sep 2026 expected | head and neck carcinoma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05126342 | Nov 2023 → Nov 2024 | fallopian tube cancer, ovarian cancer, peritoneum cancer | AGO Research GmbH | Withdrawn | No outcome recorded |
| Phase 2 | NCT05870761 | Oct 2023 → Sep 2025 overdue | endometrial serous adenocarcinoma | Casey Cosgrove | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05855811 | Jul 2023 → Jul 2028 expected | secondary malignant neoplasm | Centre Leon Berard | Recruiting | No outcome recorded |
| Phase 2 | NCT05700721 | Jun 2023 → Dec 2029 expected | metastatic malignant neoplasm in the brain | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05723562 | Apr 2023 → Nov 2026 expected | rectal cancer | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05239546 | Mar 2023 → Jun 2028 expected | colon carcinoma | University of Iowa | Recruiting | No outcome recorded |
| Phase 2 | NCT05405192 | Mar 2023 → Dec 2026 | gestational trophoblastic neoplasm | University of Miami | Withdrawn | No outcome recorded |
| Phase 2 | NCT05065021 | Feb 2023 → Jun 2025 | endometrioid adenocarcinoma, fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma +1 | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 2 | NCT05526989 | Dec 2022 → Nov 2026 expected | penile carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05565378 | Oct 2022 → Nov 2026 expected | non-small cell lung carcinoma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06926673 | Dec 2021 → May 2024 | neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT04983745 | Nov 2021 → Aug 2024 | neoplastic disease or syndrome | West Cancer Center | Unknown | No outcome recorded |
| Phase 2 | NCT04895046 | Oct 2021 → Sep 2022 | cholangiocarcinoma, metastatic malignant neoplasm | Walid Shaib, MD | Withdrawn | No outcome recorded |
| Phase 2 | NCT04837209 | Jul 2021 → Feb 2027 expected | triple-negative breast carcinoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04779151 | Apr 2021 → Feb 2025 | biliary tract cancer, clear cell renal carcinoma, gastric adenocarcinoma, gastroesophageal adenocarcinoma +3 | Gustave Roussy, Cancer Campus, Grand Paris | Terminated | No outcome recorded |
| Phase 2 | NCT04774419 | Apr 2021 → Feb 2027 expected | endometrial cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04681469 | Feb 2021 → Jun 2023 overdue | head and neck squamous cell carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT04701307 | Feb 2021 → Apr 2027 expected | small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04493060 | Dec 2020 → Dec 2023 | pancreatic ductal adenocarcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04940637 | Dec 2020 → Jun 2024 | lung cancer, mesothelioma | University of Turin, Italy | Unknown | No outcome recorded |
| Phase 2 | NCT04584255 | Dec 2020 → Jul 2025 overdue | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, Her2-receptor negative breast cancer, PALB2-related cancer predisposition +1 | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04581824 | Nov 2020 → Aug 2022 | non-small cell lung carcinoma | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT04313504 | Nov 2020 → Jun 2025 | head and neck cancer | Trisha Wise-Draper | Completed | No outcome recorded |
| Phase 2 | NCT04409002 | Jul 2020 → Jan 2022 | malignant pancreatic neoplasm | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04139902 | Jun 2020 → Sep 2025 overdue | melanoma | Diwakar Davar | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04068753 | Feb 2020 → Dec 2026 expected | cervical carcinoma | University of Oklahoma | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03680508 | Dec 2019 → Mar 2026 overdue | adult hepatocellular carcinoma | University of Hawaii | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04165772 | Dec 2019 → Nov 2026 expected | rectum adenocarcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03955471 | Oct 2019 → Aug 2021 | ovarian neoplasm | Tesaro, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03833479 | Jun 2019 → Jul 2028 expected | cervical cancer | Spanish Ovarian Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03654833 | Jan 2019 → Oct 2023 | malignant mesothelioma | University of Leicester | Unknown | No outcome recorded |
| Phase 2 | NCT03739710 | Jan 2019 → May 2024 | neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT03574779 | Nov 2018 → Jun 2024 | ovarian neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05751629 | Nov 2018 → Apr 2022 | ovarian neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03016338 | Nov 2017 → Jan 2021 overdue | endometrial cancer | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03308942 | Sep 2017 → May 2020 | neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03651206 | Jul 2020 → Jun 2027 expected | ovarian carcinosarcoma, uterine carcinosarcoma | ARCAGY/ GINECO GROUP | Recruiting | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT06762405 | Feb 2025 → Sep 2030 expected | rectum adenocarcinoma | Centre Hospitalier Universitaire Dijon | Recruiting | No outcome recorded |
| Phase 3 | NCT06472076 | Jun 2024 → Jun 2026 overdue | non-small cell lung carcinoma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06256588 | Mar 2024 → Jun 2028 expected | head and neck neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT05855200 | Aug 2023 → Mar 2029 expected | colonic neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT05201547 | Apr 2022 → Apr 2026 overdue | endometrial cancer | ARCAGY/ GINECO GROUP | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04679064 | Dec 2020 → Jan 2025 | ovarian cancer | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Unknown | No outcome recorded |
| Phase 3 | NCT03806049 | Dec 2019 → Dec 2022 | ovarian cancer | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Withdrawn | No outcome recorded |
| Phase 3 | NCT03602859 | Oct 2018 → Oct 2024 overdue | female reproductive organ cancer, ovarian neoplasm | Tesaro, Inc. | Active not recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07652515 | Aug 2026 → Aug 2030 expected | endometrial cancer | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06897527 | Jul 2025 → Jan 2027 expected | endometrial cancer | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04387084 Background | Aug 2020 → Aug 2026 overdue | skin cancer | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03843359 Background | Mar 2019 → Apr 2024 overdue | neoplasm | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02817633 Background | Jul 2016 → Mar 2027 expected | neoplasm | Tesaro, Inc. | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04655976 Background | Dec 2020 → Jun 2025 overdue | non-small cell lung carcinoma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07684599 Comparator | Sep 2026 → Jul 2029 expected | endometrial cancer | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03981796 Comparator | Jul 2019 → Nov 2026 expected | neoplasm | Tesaro, Inc. | Active not recruiting | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 103 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dostarlimab | “This is an open-label, single-arm, Phase 2 study which will evaluate the efficacy and safety of niraparib and dostarlimab (TSR-042) combination in patients with metastatic,...” NCT04983745 ↗91“Standard of Care Drugs (at investigator's discretion) may include: pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, or other immune...” NCT07224971 ↗ “ATOMICC trial: a randomized, open-label, phase II trial of anti-PD1, dostarlimab, as maintenance therapy for patients with high-risk locally advanced cervical cancer after...” PMID 35444013 ↗ Sep 2022 “TSR-042 (dostarlimab, PD-1 binding antibody)” NCT03680508 ↗ “Dostarlimab 500 mg iv: day -49 and day -28” NCT04681469 ↗ “Dostarlimab” NCT04817956 ↗ |
| Known as | Dostarlimab gxly | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298124 ↗ |
| Known as | GSK-4057190 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298124 ↗ |
| Known as | Jemperli | “Patients received a trial treatment called dostarlimab (also known by the brand name Jemperli).” PMID 34427115 ↗ Aug 2021 |
| Known as | TSR-042 | “This is an open-label, single-arm, Phase 2 study which will evaluate the efficacy and safety of niraparib and dostarlimab (TSR-042) combination in patients with metastatic,...” NCT04983745 ↗19“We propose a window of opportunity trial to evaluate safety and efficacy of a short course of the study combination, composed by an Anti-PD-1 monoclonal antibody (Dostarlimab...” NCT04681469 ↗ “This study will make it possible to evaluate the efficacy and safety of use of the combination of two products: niraparib and Dostarlimab (also called TSR-042).” NCT04779151 ↗ “TSR-042 (Dostarlimab) is a humanized mAb of the IgG4/kappa isotype that binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2.” NCT03308942 ↗ “Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer” NCT03955471 ↗ “Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1, and then again on Cycle 2 Day 1.” NCT04139902 ↗ “Dostarlimab (TSR-042) is an investigational anti-PD-1 antibody that binds with high affinity to the PD-1 receptor.” PMID 33001143 ↗ Nov 2020 “Dostarlimab (previously referred to as TSR-042) is an IgG4 antibody.” NCT03250832 ↗ “Niraparib + TSR-042 (Dostarlimab)” NCT03651206 ↗ “Dostarlimab (TSR-042), 500 mg, IV” NCT01042379 ↗ “Dostarlimab (TSR-042)” NCT03602859 ↗ |
| Known as | WBP-285 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298124 ↗ |
| Action | Inhibit | “binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2)” NCT02715284 ↗ |
| Modality | Monoclonal antibody | “Dostarlimab (160 mg, 20 mg/mL; or 500 mg, 50 mg/mL) is a humanized monoclonal antibody” NCT02715284 ↗ |
| Route | Intravenous | “Dostarlimab (TSR-042), 500 mg, IV” NCT01042379 ↗ |
| Target | PDCD1 | “Immunoglobulin G4, Anti-programmed Cell Death Protein 1 (PDCD1) (Humanized Clone ABT1 Gamma4-chain), Disulfide with Humanized Clone ABT1 Kappa-chain, Dimer” NCT04701307 ↗ |