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Dostarlimab

Aliases
dostarlimab-gxly, GSK4057190A, Jemperli, JEMPERLI (2 other aliases)
Name
dostarlimab
INN Name
dostarlimab
Target
programmed death 1 (PD-1)
FDA Approved
Yes
Ema approved
Status
0

38 clinical trials

1 organization

2 abstracts

54 indications

2 posters

1 document

Indication
Advanced Cancer
Indication
lung cancer
Indication
Head and Neck Cancer
Indication
Melanoma
Indication
Cancer
Indication
Rectal
Indication
Head and Neck
Indication
Multiple Myeloma
Indication
Serous Carcinoma
Indication
Non-Small Cell
Indication
Endometrial Cancer
Indication
cancer
Indication
Colorectal Cancer
Indication
Colorectal cancer
Indication
Ovarian Carcinoma
Indication
Ovarian Cancer
Indication
Ovarian
Indication
Fallopian Tube and Primary Peritoneal Carcinoma
Indication
Brain Metastases
Indication
Endometrial Neoplasms
Indication
Cervical Cancer
Indication
Vulvar Cancer
Indication
Vaginal Neoplasm
Indication
Clear Cell Carcinoma
Indication
Breast Cancer
Indication
Triple-Negative Breast Cancer
Indication
Adenocarcinoma
Indication
Stomach Adenocarcinoma
Indication
Colon Cancer
Indication
dMMR Colorectal Cancer
Indication
Penile Cancer
Indication
Head and Neck Squamous Cell Carcinoma
Indication
Recurrent Cancer
Indication
Primary Cancer
Indication
Second Cancer
Indication
Breast Cancer, Stage II
Indication
Stage III Breast Cancer
Indication
BRCA1 gene mutation
Indication
Germline BRCA2 Gene Mutation
Indication
PALB2 Gene Mutation
Indication
Pancreatic Ductal Adenocarcinoma
Indication
Pancreatic Cancer
Indication
Pancreatic adenocarcinoma
Indication
Ampullary Carcinoma
Indication
Adrenocortical Cancer
Indication
Neuroendocrine Carcinoma
Indication
Soft Tissue Sarcoma
Indication
Small Bowel Adenocarcinoma
Indication
Duodenal Adenocarcinoma
Indication
Melanoma stage III
Indication
melanoma
Indication
Fallopian tube cancer
Indication
Primary Peritoneal Cancer
Indication
HIV-associated Kaposi sarcoma
Clinical trial
A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
Status: Recruiting, Estimated PCD: 2024-09-01
Clinical trial
A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer
Status: Recruiting, Estimated PCD: 2026-11-02
Clinical trial
A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Nonsmall Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)
Status: Active (not recruiting), Estimated PCD: 2024-10-07
Clinical trial
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5
Status: Recruiting, Estimated PCD: 2026-02-24
Clinical trial
A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
Status: Recruiting, Estimated PCD: 2025-09-17
Clinical trial
A Randomized, Phase 2, Double-blind Study to Evaluate the Efficacy of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Metastatic Non-Squamous Non-Small Cell Lung Cancer
Status: Active (not recruiting), Estimated PCD: 2022-08-04
Clinical trial
A Pilot/Exploratory Translational Study to Evaluate Response to Dostarlimab and Pembrolizumab in Patient-derived Organoids and by Zirconium-89 Labelled Programmed Death Ligand 1 Positron Emission Tomography in Participants With Recurrent Non-small Cell Lung Cancer
Status: Not yet recruiting, Estimated PCD: 2027-01-15
Clinical trial
A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination With Anticancer Agents in Subjects With Selected Advanced Solid Tumors
Status: Completed, Estimated PCD: 2023-07-05
Clinical trial
A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors
Status: Recruiting, Estimated PCD: 2026-10-14
Clinical trial
A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer
Status: Recruiting, Estimated PCD: 2025-01-17
Clinical trial
A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Japanese Patients With Primary Advanced or Recurrent Endometrial Cancer (RUBY-J)
Status: Not yet recruiting, Estimated PCD: 2026-07-15
Clinical trial
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Status: Not yet recruiting, Estimated PCD: 2028-06-09
Clinical trial
A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, Alone and in Combination With an Anti-PD-1 in Patients With Advanced Solid Tumors
Status: Completed, Estimated PCD: 2022-06-02
Clinical trial
A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Status: Recruiting, Estimated PCD: 2028-12-15
Clinical trial
A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors
Status: Active (not recruiting), Estimated PCD: 2024-04-05
Clinical trial
A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors
Status: Recruiting, Estimated PCD: 2026-05-15
Clinical trial
A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments And/Or Combinations of Treatments in Participants With Ovarian Cancer (OPAL)
Status: Recruiting, Estimated PCD: 2024-08-06
Clinical trial
A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
Status: Recruiting, Estimated PCD: 2025-09-03
Clinical trial
A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants
Status: Recruiting, Estimated PCD: 2025-07-08
Clinical trial
A PHASE 1, MULTICENTRE, OPEN-LABEL, DOSE-ESCALATION AND COHORT EXPANSION STUDY OF NIRAPARIB AND DOSTARLIMAB IN PAEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMOURS
Status: , Estimated PCD: 2028-09-28
Clinical trial
A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer (RUBY)
Status: Active (not recruiting), Estimated PCD: 2026-11-26
Clinical trial
A Randomized, Double-blind, Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
Status: Active (not recruiting), Estimated PCD: 2024-03-29
Poster
Antitumor Activity of Dostarlimab in Patients with Mismatch Repair–Deficient (dMMR) Tumors: a Combined Analysis of 2 Cohorts in the GARNET Study
Poster
Antitumor Activity of Dostarlimab in Patients with Mismatch Repair–Deficient (dMMR) Tumors: a Combined Analysis of 2 Cohorts in the GARNET Study
Abstract
Dostarlimab for primary advanced or recurrent (A/R) endometrial cancer (EC): Outcomes by blinded independent central review (BICR) of the RUBY trial (ENGOT-EN6-NSGO/GOG-3031/RUBY).
Org: US Oncology Research, HonorHealth Research Institute, Creighton University School of Medicine, The Ohio State University James Cancer Center, Division of Gynecologic Oncology,
Abstract
Patient-reported outcomes (PROs) in primary advanced or recurrent endometrial cancer (pA/rEC) for patients (pts) treated with dostarlimab plus carboplatin/paclitaxel (CP) as compared to CP in the ENGOT-EN6/GOG3031/RUBY trial.
Org: Copenhagen University Hospital, Washington University School of Medicine, ModernaTX, Rigshospitalet, Nordic Society of Gynaecologic Oncology–Clinical Trial Unit,
Clinical trial
Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)
Status: Recruiting, Estimated PCD: 2025-08-07
Clinical trial
An Open-label, Phase II Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients
Status: Active (not recruiting), Estimated PCD: 2024-06-01
Clinical trial
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV07/ ENGOT-ov80 Study)
Status: Not yet recruiting, Estimated PCD: 2027-08-31
Clinical trial
A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)
Status: Recruiting, Estimated PCD: 2025-04-01
Clinical trial
Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
Status: Recruiting, Estimated PCD: 2026-03-01
Clinical trial
Watch-and-wait Strategy to Initiate Dostarlimab-based Immunotherapy in Localized Deficient Mismatch Repair (dMMR) and/or Microsatellite Instability High (MSI-H) oEso-gastric Junction and Gastric Adenocarcinoma: An Open-label GERCOR Phase II Study
Status: Recruiting, Estimated PCD: 2028-09-01
Clinical trial
Phase II, Single Arm Study of Neoadjuvant Dostarlimab (TSR-042) in Stage II and III Deficient Mismatch Repair Colon Cancers
Status: Recruiting, Estimated PCD: 2026-04-01
Clinical trial
A Phase 2 Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma Who Have Progressed Following Chemotherapy
Status: Recruiting, Estimated PCD: 2025-10-01
Clinical trial
Phase Ib/II Non-randomized Non-comparative Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma
Status: Recruiting, Estimated PCD: 2027-09-01
Clinical trial
A Multicenter, Open-label, Randomized Phase II Study Aiming to Assess the Clinical Impact of Dostarlimab on Occurrence of Second Primary Cancer in Patients With Cured Primary Cancer
Status: Recruiting, Estimated PCD: 2028-07-26
Clinical trial
A Phase II Study of Niraparib With Dostarlimab Therapy as Neoadjuvant Treatment for Patients With BRCA-mutated Breast Cancer
Status: Recruiting, Estimated PCD: 2025-07-17
Clinical trial
Phase II Study of Niraparib and TSR-042 in Patients With Germline or Somatic BRCA1/2 and PALB2-Related Pancreatic Cancer
Status: Active (not recruiting), Estimated PCD: 2023-12-07
Clinical trial
Dostarlimab as First-line Treatment for Patients With dMMR/MSI (Non-colorectal/Non-endometrial) Locally Advanced or Metastatic Cancer: a Randomized Phase 2 Trial (Cohort Pan-MSI ACSE) With Crossover in the Standard Arm at Progression
Status: Not yet recruiting, Estimated PCD: 2028-10-01
Clinical trial
Randomized Phase II Neoadjuvant Study of PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Resectable Stage III or Oligometastatic Stage IV Melanoma (Neo-MEL-T)
Status: Recruiting, Estimated PCD: 2025-01-01
Clinical trial
Re-VOLVE: A Phase II Clinical Trial in Women With Ovarian Cancer Progressing Post-PARP Inhibitor With Treatment Adapted to Real-time Assessment of Evolving Genomic Resistance
Status: Recruiting, Estimated PCD: 2025-06-06
Clinical trial
Preliminary Assessment of Safety and Tolerability of Dostarlimab in Combination Antiretroviral Therapy (cART) Refractory HIV Associated Kaposi Sarcoma
Status: Recruiting, Estimated PCD: 2024-05-01
Document
DailyMed Label: Jemperli
Organization
GlaxoSmithKline LLC