32 active not recruiting, 30 recruiting, 12 completed, 10 terminated. 69 Phase 2, 28 Phase 1, 14 Phase 3, 2 Phase 4.
By phase and status
Phase Trials Status Phase 2 69 Recruiting 23 , Active not recruiting 20 , Completed 9 , Terminated 6 , Withdrawn 5 , Not yet recruiting 3 , Unknown 3 Phase 1 28 Active not recruiting 12 , Terminated 6 , Recruiting 5 , Completed 3 , Unknown 1 , Withdrawn 1 Phase 3 14 Active not recruiting 5 , Recruiting 5 , Not yet recruiting 2 , Unknown 1 , Withdrawn 1 Phase 4 2 Not yet recruiting 2
Follow dostarlimab: new trials by email Literature Review of dostarlimab trials Research Report on dostarlimab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
Two Part (Phase1b/ Phase3) Trial of Subcutaneous Dostarlimab Plus Carboplatin-Paclitaxel in Participants With Primary Advanced or Recurrent Endometrial Cancer Dostarlimab, Carboplatin and paclitaxel - Endometrial Carcinoma, Neoplasms, Endometrial Phase 3 Not yet recruiting GlaxoSmithKline 378 2026-11-12 2026-10-19 A Study to Investigate Mocertatug Rezetecan as Maintenance Treatment for Participants With MMRp Endometrial Cancer (BEHOLD-Endometrial02) Mocertatug rezetecan, Dostarlimab, Pembrolizumab - Neoplasms, Endometrial Phase 3 Recruiting GlaxoSmithKline 610 2026-09-24 2026-10-15 A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer Dostarlimab - Neoplasms, Rectal Phase 3 Not yet recruiting GlaxoSmithKline 90 2026-09-17 2026-08-03 A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer Dostarlimab, Carboplatin, Paclitaxel - Neoplasms, Endometrial Phase 4 Not yet recruiting GlaxoSmithKline 100 2026-08-17 2026-06-17 A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Resistance in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) GSK5764227, Dostarlimab - Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Phase 2 Recruiting University Health Network, Toronto 30 2026-04-27 2026-10-01 XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients XELOX (Capecitabine and Oxaliplatin), Dostarlimab - Locally Advanced Rectal Cancer (LARC) Phase 2 Not yet recruiting Gruppo Oncologico Italiano di Ricerca Clinica 270 2026-01-31 2026-02-02 Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma Dostarlimab - Female Phase 2 Recruiting Chang Gung Memorial Hospital 45 2025-12-22 2026-08-17 A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC) Dostarlimab, Carboplatin, Paclitaxel - Neoplasms, Endometrial Phase 2 Recruiting GlaxoSmithKline 30 2025-11-27 2025-12-22 Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC) Pembrolizumab, Dostarlimab, Pemetrexed+ (carboplatin or cisplatin) - Lung Cancer, Non-Small Cell Phase 1 / Phase 2 Terminated GlaxoSmithKline 2 2025-10-10 2026-09-03 Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer Dostarlimab - MMRd/MSI-H Stage II-III Endometrial Cancer Phase 2 Not yet recruiting Grupo Español de Investigación en Cáncer de Ovario 25 2025-10-01 2025-06-10 pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer Dostarlimab - Endometrial Cancer Phase 2 Not yet recruiting University College, London 40 2025-09-30 2025-08-19 Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer Dostarlimab - Locally Advanced Rectal Cancer (LARC) Recruiting National Cancer Institute, Naples 50 2025-09-01 2025-12-08 A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC) Dostarlimab - Neoplasms, Endometrial Phase 4 Not yet recruiting GlaxoSmithKline 100 2025-07-15 2025-07-08 A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients roginolisib, Dostarlimab, Docetaxel - Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Advanced Non Squamous NSCLC Phase 1 / Phase 2 Active not recruiting iOnctura 45 2025-04-22 2026-01-16 Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer Dostarlimab - Colon Cancer Stage III Phase 2 Recruiting Universitaire Ziekenhuizen KU Leuven 10 2025-04-03 2026-02-12 A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer Cobolimab, Dostarlimab - Melanoma, Hodgkin Lymphoma Phase 1 / Phase 2 Active not recruiting GlaxoSmithKline 83 2025-03-06 2025-11-12 A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2) Mo-Rez, Dostarlimab, Bevacizumab - Tumours, Gynecological Phase 1 / Phase 2 Recruiting GlaxoSmithKline 305 2025-03-04 2026-10-02 DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer Dostarlimab, Vitamin D3 (Cholecalciferol), mFOLFIRINOX Treatment Regimen - Pancreas Neoplasms Phase 2 Recruiting Hopital Foch 35 2025-02-18 2025-03-18 A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer Dostarlimab, CAPEOX - Neoplasms, Colon Phase 2 Recruiting GlaxoSmithKline 120 2025-02-18 2026-05-22 PRODIGE 90 - (FFCD 2204) Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-deficient Locally Advanced Rectal Cancer Patients radiotherapy, Dostarlimab, Biological study on circulating tumor DNA (optional for the patient) - Rectal Adenocarcinoma with Mismatch-repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Phase 3 Recruiting Centre Hospitalier Universitaire Dijon 68 2025-02-06 2025-02-18
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Conditions studied Neoplasms (19) · Endometrial Neoplasms (18) · Ovarian Neoplasms (11) · Carcinoma, Non-Small-Cell Lung (10) · Neoplasm Metastasis (7) · Squamous Cell Carcinoma of Head and Neck (6) · Breast Neoplasms (5) · Head and Neck Neoplasms (5) · Rectal Neoplasms (5) · Uterine Cervical Neoplasms (5) · Colonic Neoplasms (4) · Lung Neoplasms (4) · Melanoma (4) · Pancreatic Neoplasms (4) · Colorectal Neoplasms (3)
Sponsors GlaxoSmithKline (30) · Tesaro, Inc. (10) · M.D. Anderson Cancer Center (4) · Grupo Español de Investigación en Cáncer de Ovario (3) · University Health Network, Toronto (3) · ARCAGY/ GINECO GROUP (2) · Massachusetts General Hospital (2) · Memorial Sloan Kettering Cancer Center (2) · University of Iowa (2) · AGO Research GmbH (1) · Casey Cosgrove (1) · Centre Hospitalier Universitaire Dijon (1) · Centre Leon Berard (1) · Chang Gung Memorial Hospital (1) · Dana-Farber Cancer Institute (1)
Countries United States (55) · Spain (31) · France (30) · Italy (28) · Canada (23) · South Korea (21) · Japan (19) · United Kingdom (19) · Germany (14) · Belgium (12) · Netherlands (12) · Poland (12) · Argentina (10) · Australia (10) · Brazil (10)
Top investigators Alejandro Gallego Martinez (1) · Amir Jazaeri, M D (1) · Amit M Oza, M.D. (1) · Ana Oaknin, PhD (1) · Andrea Cercek, MD (1) · Andreas Obermair, Professor (1) · Carl M Gay, MD,PHD (1) · Casey Cosgrove, MD (1) · Dean Fennell, PhD, FRCP (1) · Debra Richardson, MD (1) · Diwakar Davar, MD (1) · Elizabeth M. Swisher (1) · Erica L. Mayer, MD, MPH (1)
Results publications PMID 21796368 , PMID 22198468 , PMID 22623692 , PMID 22649152 , PMID 27406346 , PMID 27406347 , PMID 28851423 , PMID 32031889 , PMID 32053137 , PMID 32450725 , PMID 32701140 , PMID 33001143 , PMID 33515503 , PMID 33682447 , PMID 33730360 , PMID 34427115 , PMID 34529000 , PMID 34607820 , PMID 34741021 , PMID 35157829 , PMID 35444013 , PMID 35568909 , PMID 35623341 , PMID 35660797 , PMID 35729005 , PMID 35892341 , PMID 35993306 , PMID 36069821 , PMID 36456573 , PMID 36648215 , PMID 36972026 , PMID 37029329 , PMID 37222204 , PMID 37325931 , PMID 37363992 , PMID 37411031 , PMID 37505107 , PMID 37593752 , PMID 37659907 , PMID 37731489 , PMID 37890345 , PMID 37917058 , PMID 38086377 , PMID 38180338 , PMID 38431043 , PMID 38702828 , PMID 38745646 , PMID 38754056 , PMID 38932511 , PMID 38990090
NIH funding 2023 (9), 2018 (4), 2025 (2), 2016 (1), 2019 (1), P30CA014089 (1)