How many Dostarlimab clinical trials are there?

87 Dostarlimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 28 are actively recruiting participants. 9 are marked completed.

Are Dostarlimab clinical trials recruiting in 2026?

Yes — 28 Dostarlimab trials are actively recruiting in 2026, with 133 U.S. sites across 34 states. See the recruiting trials and the per-state site list further down this page.

What conditions is Dostarlimab being studied for?

Dostarlimab is being studied for Neoplasms, Endometrial Cancer, Lung Cancer, Non-Small Cell, Ovarian Neoplasms, Breast Cancer and 162 more. The trials are grouped by indication on this page.

What phase is Dostarlimab in?

Dostarlimab clinical trials span 1 Phase 4, 9 Phase 3, 49 Phase 2, 13 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.

Who sponsors Dostarlimab clinical trials?

The lead sponsor across the most Dostarlimab trials is GlaxoSmithKline, with 46 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Dostarlimab Clinical Trials (2026): 87 Studies for Neoplasms & Endometrial Cancer

Creator: Hipa.ai Research
Published: 2026-06-02T16:50:13.883Z

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: June 12, 2026.

87 Dostarlimab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 60 indications (including Neoplasms & Endometrial Cancer) and 18,996 total planned enrollment. 9 Phase 3 Dostarlimab trials and 49 Phase 2, 1 Phase 4 are listed. 32 Dostarlimab clinical trials are actively recruiting at 133 U.S. sites across 34 states. Most recent activity: NCT01042379 (Dec 2031).

Where to Participate: All Dostarlimab Trial Sites in the U.S. (133 sites across 34 states)

Every actively recruiting Dostarlimabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

State	Facility	City	Trial	Map
AL	O'Neal Comprehensive Cancer Center at UAB	Birmingham35294	NCT05559879	Map
AL	University of Alabama at Birmingham	Birmingham35294	NCT01042379	Map
AZ	GSK Investigational Site	Tucson85715	NCT05855200	Map
AR	GSK Investigational Site	Jonesboro72401	NCT06256588	Map
CA	University of California - Davis, Comprehensive Cancer Center	Davis95817	NCT01042379	Map
CA	City of Hope	Duarte91010	NCT01042379	Map
CA	GSK Investigational Site	La Jolla92093	NCT06796907	Map
CA	University of California San Diego	La Jolla92093-0698	NCT01042379	Map
CA	GSK Investigational Site	Los Angeles90027	NCT05855200	Map
CA	GSK Investigational Site	Los Angeles90095	NCT06256588	Map
CA	University of Southern California	Los Angeles90033	NCT01042379	Map
CA	HOAG Memorial Hospital Presbyterian	Newport Beach92663	NCT01042379	Map
CA	University of California San Francisco (UCSF)	San Francisco94115	NCT01042379	Map
CA	GSK Investigational Site	Solvang93463	NCT06256588	Map
CA	GSK Investigational Site	Stanford94063	NCT06551142	Map
CA	GSK Investigational Site	Stockton95204	NCT06256588	Map
CA	GSK Investigational Site	Torrance90505	NCT06256588	Map
CO	University of Colorado Cancer Center	Aurora80045	NCT01042379	Map
CO	GSK Investigational Site	Denver80218	NCT06551142	Map
CT	GSK Investigational Site	Farmington06030-1628	NCT06256588	Map
CT	Hartford Healthcare (Data Collection)	Hartford06102	NCT04165772	Map
CT	GSK Investigational Site	New Haven06520	NCT05855200	Map
CT	GSK Investigational Site	New Haven06520	NCT06256588	Map
CT	GSK Investigational Site	New Haven06511	NCT06551142	Map
CT	Yale Cancer Center	New Haven06510	NCT01042379	Map
DC	Georgetown University Medical Center	Washington D.C.20007	NCT01042379	Map
DC	GSK Investigational Site	Washington D.C.20010	NCT06256588	Map
FL	Baptist Alliance MCI (Data Collection Only)	Miami33143	NCT04165772	Map
FL	GSK Investigational Site	St. Petersburg33709	NCT06256588	Map
FL	H. Lee Moffitt Cancer Center and Research Institute	Tampa33612	NCT01042379	Map
FL	Moffitt Cancer Center	Tampa33612	NCT05526989	Map
FL	Moffitt Cancer Center	Tampa33612	NCT01042379	Map
GA	GSK Investigational Site	Atlanta30322	NCT06256588	Map
GA	Winship Cancer Institute of Emory University	Atlanta30322	NCT01042379	Map
IL	GSK Investigational Site	Chicago60611	NCT05855200	Map
IL	GSK Investigational Site	Chicago60612	NCT05855200	Map
IL	University of Chicago	Chicago60453	NCT01042379	Map
IL	Loyola University	Maywood60153	NCT01042379	Map
IL	GSK Investigational Site	Naperville60126	NCT05855200	Map
IL	GSK Investigational Site	Naperville60540	NCT05855200	Map
IN	GSK Investigational Site	Fort Wayne46804	NCT06256588	Map
IN	GSK Investigational Site	Fort Wayne46804	NCT06551142	Map
IA	GSK Investigational Site	Iowa City52242	NCT06256588	Map
IA	University of Iowa Hospitals & Clinics	Iowa City52242	NCT05239546	Map
KS	GSK Investigational Site	Westwood66205	NCT05855200	Map
KY	GSK Investigational Site	Lexington40536	NCT06256588	Map
MD	GSK Investigational Site	Bethesda20817	NCT05855200	Map
MD	GSK Investigational Site	Columbia21044	NCT06256588	Map
MA	GSK Investigational Site	Boston02114	NCT06551142	Map
MA	GSK Investigational Site	Worcester01655-0002	NCT06256588	Map
MI	GSK Investigational Site	Detroit48202	NCT05855200	Map
MI	GSK Investigational Site	Detroit48201	NCT06551142	Map
MI	Herbert-Herman Cancer Center, Sparrow Hospital	Lansing48912	NCT01042379	Map
MN	GSK Investigational Site	Minneapolis55455	NCT05855200	Map
MN	University of Minnesota	Minneapolis55455	NCT01042379	Map
MN	Mayo Clinic	Rochester55905	NCT01042379	Map
MN	Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center	Saint Louis Park55416	NCT01042379	Map
MO	GSK Investigational Site	St Louis63110	NCT06256588	Map
NE	GSK Investigational Site	Grand Island68803	NCT05855200	Map
NE	GSK Investigational Site	Omaha68130	NCT05855200	Map
NE	GSK Investigational Site	Omaha68114	NCT06256588	Map
NJ	Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities	Basking Ridge07920	NCT04165772	Map
NJ	Memorial Sloan Kettering Basking Ridge (All Protocol Activites)	Basking Ridge07920	NCT04774419	Map
NJ	Memorial Sloan Kettering Monmouth - Limited Protocol Activities	Middletown07748	NCT04165772	Map
NJ	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown07748	NCT04774419	Map
NJ	Memorial Sloan Kettering Bergen - Limited Protocol Activities	Montvale07645	NCT04165772	Map
NJ	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale07645	NCT04774419	Map
NJ	GSK Investigational Site	New Brunswick08903	NCT06551142	Map
NJ	Rutgers Cancer Institute of New Jersey	New Brunswick08903	NCT01042379	Map
NY	Roswell Park Cancer Institute	Buffalo14263	NCT01042379	Map
NY	Memorial Sloan Kettering Commack - Limited Protocol Activities	Commack11725	NCT04165772	Map
NY	Memorial Sloan Kettering Commack (All Protocol Activities)	Commack11725	NCT04774419	Map
NY	Memorial Sloan Kettering Westchester - Limited Protocol Activities	Harrison10604	NCT04165772	Map
NY	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison10604	NCT04774419	Map
NY	Columbia University Medical Center	New York10032	NCT01042379	Map
NY	GSK Investigational Site	New York10028	NCT05855200	Map
NY	GSK Investigational Site	New York10469	NCT05855200	Map
NY	GSK Investigational Site	New York11042	NCT05855200	Map
NY	GSK Investigational Site	New York11967	NCT05855200	Map
NY	Laura and Isaac Perlmutter Cancer Center / NYU Langone Health	New York10016	NCT01042379	Map
NY	Memorial Sloan Kettering Cancer Center	New York10065	NCT04774419	Map
NY	Memorial Sloan Kettering Cancer Center	New York10065	NCT04165772	Map
NY	GSK Investigational Site	Rochester55905-0001	NCT06796907	Map
NY	University of Rochester Wilmot Cancer Institute	Rochester14642	NCT01042379	Map
NY	Memorial Sloan Kettering Nassau (All Protocol Activities)	Rockville Centre11570	NCT04774419	Map
NY	GSK Investigational Site	The Bronx10461	NCT05855200	Map
NY	GSK Investigational Site	The Bronx10468	NCT06256588	Map
NY	Montefiore Medical Center	The Bronx10467	NCT01042379	Map
NY	Memorial Sloan Kettering Nassau - Limited Protocol Activities	Uniondale11553	NCT04165772	Map
NC	GSK Investigational Site	Durham27710	NCT05855200	Map
NC	GSK Investigational Site	Durham27710	NCT06796907	Map
NC	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem27157	NCT01042379	Map
OH	GSK Investigational Site	Akron44304	NCT05855200	Map
OH	GSK Investigational Site	Canton44718	NCT06256588	Map
OH	GSK Investigational Site	Cincinnati45220	NCT05855200	Map
OH	Cleveland Clinic	Cleveland44106	NCT01042379	Map
OH	GSK Investigational Site	Columbus43210	NCT06796907	Map
OH	The Ohio State University, Stefanie Spielman Comprehensive Breast Center	Columbus43212	NCT01042379	Map
OK	GSK Investigational Site	Tulsa74146	NCT06256588	Map
OR	Oregon Health & Science Institute (OHSU)	Portland97239	NCT01042379	Map
PA	Lehigh Valley Health Network (Data Collection Only)	Allentown18103	NCT04165772	Map
PA	GSK Investigational Site	Philadelphia19107	NCT06256588	Map
PA	University of Pennsylvania (U Penn)	Philadelphia19104	NCT01042379	Map
PA	GSK Investigational Site	Pittsburgh15212	NCT06256588	Map
SC	GSK Investigational Site	Charleston29425	NCT06256588	Map
SC	GSK Investigational Site	Myrtle Beach29572	NCT06551142	Map
SD	GSK Investigational Site	Sioux Falls57078	NCT05855200	Map
SD	GSK Investigational Site	Sioux Falls57105	NCT05855200	Map
SD	GSK Investigational Site	Sioux Falls57401	NCT05855200	Map
SD	GSK Investigational Site	Sioux Falls57501	NCT05855200	Map
SD	Sanford Clinical Research	Sioux Falls57104	NCT01042379	Map
TN	GSK Investigational Site	Chattanooga37404	NCT06256588	Map
TN	GSK Investigational Site	Germantown38138	NCT06256588	Map
TN	GSK Investigational Site	Nashville37203	NCT06256588	Map
TN	GSK Investigational Site	Nashville37203	NCT06551142	Map
TX	GSK Investigational Site	Austin78705	NCT06551142	Map
TX	GSK Investigational Site	Dallas75246	NCT06256588	Map
TX	GSK Investigational Site	Dallas75230	NCT06551142	Map
TX	GSK Investigational Site	Fort Worth76104	NCT06256588	Map
TX	M D Anderson Cancer Center	Houston77030	NCT05700721	Map
TX	M D Anderson Cancer Center	Houston77030	NCT05819892	Map
TX	M D Anderson Cancer Center	Houston77030	NCT06065462	Map
TX	MD Anderson Cancer Center	Houston77030	NCT05526989	Map
TX	GSK Investigational Site	San Antonio78217	NCT06256588	Map
TX	GSK Investigational Site	San Antonio78229	NCT06551142	Map
TX	GSK Investigational Site	Tyler75702	NCT06551142	Map
UT	Huntsman Cancer Institute, University of Utah	Salt Lake City84112	NCT01042379	Map
UT	GSK Investigational Site	West Valley City84119	NCT06551142	Map
VA	GSK Investigational Site	Fredericksburg22408	NCT06256588	Map
VA	GSK Investigational Site	Norfolk23502	NCT06551142	Map
VA	GSK Investigational Site	Richmond23229	NCT05855200	Map
VA	GSK Investigational Site	Wytheville24382	NCT06256588	Map
WI	GSK Investigational Site	Appleton54911	NCT05855200	Map

Dostarlimab clinical trials at a glance: phase × recruitment status

Phase	recruiting	active not recruiting	completed	terminated	withdrawn	not yet recruiting	unknown	Total
P1	2	7	2	2				13
P1/P2	4	5		2	1			12
P2	17	12	7	3	4	3	3	49
P2/P3	1							1
P3	3	5					1	9
P4						1		1
N/A	1						1	2

Recruiting Dostarlimab clinical trials (32)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT ID	Title	Phase	Indication	Enrollment	Started
NCT01042379	I-SPYI-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer	P2	Breast Neoplasms	5,000	Mar 2010
NCT05855200	Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer	P3	Colonic Neoplasms	892	Aug 2023
NCT07408063	BeeHiveA 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)	P2	Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma	30	Apr 2026
NCT07115927	RODEOpReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer	P2	Endometrial Cancer	40	Sep 2025
NCT07381777	IMMUNOSTARXELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients	P2	Locally Advanced Rectal Cancer (LARC)	270	Jan 2026
NCT07336147	Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma	P2	Female	45	Dec 2025
NCT06762405	PREDIR-NEORECPRODIGE 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	P3	Rectal Adenocarcinoma with Mismatch-repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H)	68	Feb 2025
NCT06333314	Pan-MSI-ACSEDostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI	P2	Pancreatic Adenocarcinoma	120	Jul 2024
NCT07108270	ECA Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)	P2	Neoplasms, Endometrial	30	Nov 2025
NCT06023862	DOVEA Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)	P2	Ovarian Neoplasms	198	Jan 2024
NCT05700721	STARLETPhase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)	P2	Brain Metastases	120	Jun 2023
NCT06256588	JADEA Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma	P3	Neoplasms, Head and Neck	864	Mar 2024
NCT06405230	PDL1Evaluation 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)	P1/P2	Lung Cancer, Non-Small Cell	40	Dec 2025
NCT07013851	NADIAClinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer	P2	MMRd/MSI-H Stage II-III Endometrial Cancer	25	Oct 2025
NCT05239546	NAIOSingle Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers	P2	Colon Cancer	25	Mar 2023
NCT06551142	PanTumor-101A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)	P1	Neoplasms	845	Sep 2024
NCT03651206	ROCSANRecurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib	P2/P3	Ovarian Carcinosarcoma	138	Jul 2020
NCT05855811	PREDOSTARPREventing Second Cancers With DOSTARlimab	P2	Recurrent Cancer	400	Jul 2023
NCT06830239	SuperheroPhase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer	P2	Colon Cancer Stage III	10	Apr 2025
NCT06567782	AZUR-4A 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	P2	Neoplasms, Colon	120	Feb 2025
NCT06796907	BEHOLD-2A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors	P1/P2	Tumours, Gynecological	305	Mar 2025
NCT06059495	DEWIWatch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study	P2	Adenocarcinoma - GEJ	59	Dec 2023
NCT06278857	SATELLITESATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)	P2	Endometrial Cancer Stage I	10	Aug 2024
NCT05819892	Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer	P1	Endometrial Cancer	21	Jul 2023
NCT06757244	DOVIPADOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer	P2	Pancreas Neoplasms	35	Feb 2025
NCT07269249	RW-NEDOSReal-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer	—	Locally Advanced Rectal Cancer (LARC)	50	Sep 2025
NCT05526989	Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma	P2	Penile Carcinoma	25	Dec 2022
NCT06065462	Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100	P1/P2	Ovarian Clear Cell Carcinoma	21	Nov 2023
NCT05559879	Cabozantinib and Dostarlimab in Recurrent Gynecologic Carcinosarcoma	P1/P2	Gynecologic Cancer	37	Aug 2023
NCT04774419	Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery	P2	Endometrial Cancer	62	Apr 2021
NCT06897527	ECA Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)	P4	Neoplasms, Endometrial	100	Jul 2025
NCT04165772	Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors	P2	Rectal Adenocarcinoma	212	Dec 2019

Dostarlimab clinical trials by indication

Neoplasms (12)

NCT	Acronym	Phase	Status	Title
NCT06551142	PanTumor-101	P1	recruiting	A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
NCT05277051	—	P1	active not recruiting	First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors
NCT02715284	GARNET	P1	active not recruiting	Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors
NCT04446351	—	P1	active not recruiting	Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors
NCT03981796	RUBY	P3	active not recruiting	A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
NCT03843359	FTIH	P1	active not recruiting	A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors
NCT04544995	SCOOP	P1	terminated	Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)
NCT06926673	NSCLC	P2	completed	Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 3
+ 4 more, see All trials below.

Endometrial Cancer (6)

NCT	Acronym	Phase	Status	Title
NCT07115927	RODEO	P2	not yet recruiting	pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer
NCT05201547	DOMENICA	P3	active not recruiting	Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
NCT05819892	—	P1	recruiting	Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
NCT04774419	—	P2	recruiting	Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery
NCT06385548	LiDer	P1/P2	withdrawn	Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer
NCT05728814	DORA	N/A	unknown	DOstarlimab in Patients With Recurrent or dMMR/MSI-H Endometrial Cancer

Lung Cancer, Non-Small Cell (5)

NCT	Acronym	Phase	Status	Title
NCT06405230	PDL1	P1/P2	recruiting	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)
NCT04655976	COSTAR Lung	P3	active not recruiting	Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy
NCT05565378	—	P2	active not recruiting	A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
NCT06472076	PD-L1	P3	active not recruiting	A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)
NCT04581824	NSCLC	P2	terminated	Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

Ovarian Neoplasms (3)

NCT	Acronym	Phase	Status	Title
NCT06023862	DOVE	P2	recruiting	A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
NCT03602859	FIRST	P3	active not recruiting	A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
NCT03955471	MOONSTONE	P2	terminated	Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer

Locally Advanced Rectal Cancer (LARC) (2)

NCT	Acronym	Phase	Status	Title
NCT07381777	IMMUNOSTAR	P2	not yet recruiting	XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients
NCT07269249	RW-NEDOS	N/A	recruiting	Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer

Neoplasms, Endometrial (2)

NCT	Acronym	Phase	Status	Title
NCT07108270	EC	P2	recruiting	A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)
NCT06897527	EC	P4	not yet recruiting	A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)

Neoplasms, Rectal (2)

NCT	Acronym	Phase	Status	Title
NCT06640049	China AZUR-1	P2	active not recruiting	A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China
NCT05723562	AZUR-1	P2	active not recruiting	A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

Neoplasms, Head and Neck (2)

NCT	Acronym	Phase	Status	Title
NCT06256588	JADE	P3	recruiting	A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
NCT06062420	—	P2	active not recruiting	A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202

Ovarian Cancer (2)

NCT	Acronym	Phase	Status	Title
NCT05065021	—	P2	unknown	Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor
NCT04679064	NItCHE-MITO33	P3	unknown	Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT07408063	BeeHive	P2	recruiting	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)

Female (1)

NCT	Acronym	Phase	Status	Title
NCT07336147	—	P2	recruiting	Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma

MMRd/MSI-H Stage II-III Endometrial Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT07013851	NADIA	P2	not yet recruiting	Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (1)

NCT	Acronym	Phase	Status	Title
NCT06879717	PULMO-01	P1/P2	active not recruiting	A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients

Colon Cancer Stage III (1)

NCT	Acronym	Phase	Status	Title
NCT06830239	Superhero	P2	recruiting	Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer

Melanoma (1)

NCT	Acronym	Phase	Status	Title
NCT06521567	—	P1/P2	active not recruiting	A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer

Tumours, Gynecological (1)

NCT	Acronym	Phase	Status	Title
NCT06796907	BEHOLD-2	P1/P2	recruiting	A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors

Pancreas Neoplasms (1)

NCT	Acronym	Phase	Status	Title
NCT06757244	DOVIPA	P2	recruiting	DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer

Neoplasms, Colon (1)

NCT	Acronym	Phase	Status	Title
NCT06567782	AZUR-4	P2	recruiting	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

Rectal Adenocarcinoma with Mismatch-repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) (1)

NCT	Acronym	Phase	Status	Title
NCT06762405	PREDIR-NEOREC	P3	recruiting	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

MMR-D/MSI-H Colorectal Cancers (1)

NCT	Acronym	Phase	Status	Title
NCT06365970	—	P2	withdrawn	Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers

Endometrial Cancer Stage I (1)

NCT	Acronym	Phase	Status	Title
NCT06278857	SATELLITE	P2	recruiting	SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)

Pancreatic Adenocarcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT06333314	Pan-MSI-ACSE	P2	recruiting	Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI

Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT06317311	RUBY-J	P2	active not recruiting	A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer

Cervical Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT06238635	—	P2	active not recruiting	Dostarlimab and Cobolimab in Advanced Cervical Cancer

Adenocarcinoma - GEJ (1)

NCT	Acronym	Phase	Status	Title
NCT06059495	DEWI	P2	recruiting	Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study

Ovarian Clear Cell Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT06065462	—	P1/P2	recruiting	Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100

Head and Neck Squamous Cell Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT05784012	RADIAN	P1/P2	active not recruiting	Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma

Recurrent Ovarian Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT05126342	—	P2	withdrawn	Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi

Recurrent Endometrial Serous Adenocarcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT05870761	—	P2	active not recruiting	Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

Gynecologic Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT05559879	—	P1/P2	recruiting	Cabozantinib and Dostarlimab in Recurrent Gynecologic Carcinosarcoma

Stomach Neoplasm (1)

NCT	Acronym	Phase	Status	Title
NCT05980416	—	P1	terminated	Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2

Colonic Neoplasms (1)

NCT	Acronym	Phase	Status	Title
NCT05855200	—	P3	recruiting	Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Recurrent Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT05855811	PREDOSTAR	P2	recruiting	PREventing Second Cancers With DOSTARlimab

Brain Metastases (1)

NCT	Acronym	Phase	Status	Title
NCT05700721	STARLET	P2	recruiting	Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

Refractory HIV Associated Kaposi Sarcoma (1)

NCT	Acronym	Phase	Status	Title
NCT05646082	STARKAP	P1	active not recruiting	Preliminary Assessment of Safety and Tolerability of Dostarlimab in Combination Antiretroviral Therapy (cART) Refractory HIV Associated Kaposi Sarcoma

Colon Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT05239546	NAIO	P2	recruiting	Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers

Gestational Trophoblastic Neoplasia (1)

NCT	Acronym	Phase	Status	Title
NCT05405192	—	P2	withdrawn	Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia

Penile Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT05526989	—	P2	recruiting	Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma

Rectal Neoplasms (1)

NCT	Acronym	Phase	Status	Title
NCT04926324	—	P1/P2	terminated	A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers

Anatomic Stage III Breast Cancer AJCC v8 (1)

NCT	Acronym	Phase	Status	Title
NCT04673448	—	P1	active not recruiting	Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer

HRD (1)

NCT	Acronym	Phase	Status	Title
NCT04895046	—	P2	withdrawn	Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

Advanced Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT05060432	TIG-006	P1/P2	active not recruiting	Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

Breast Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT04837209	NADiR	P2	active not recruiting	Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer

Urothelial Bladder Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT04779151	NIRADO	P2	terminated	Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab

Relapsed/Refractory Multiple Myeloma (1)

NCT	Acronym	Phase	Status	Title
NCT06655818	GSK2857916	P1/P2	terminated	Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Dostarlimab (GSK4057190) in Participants With RRMM

Lung Small Cell Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT04701307	—	P2	active not recruiting	Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas

Metastatic Pancreatic Ductal Adenocarcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT04493060	—	P2	completed	Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer

Lung Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT04940637	UNITO-001	P2	unknown	UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC

Stage I Breast Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT04584255	—	P2	active not recruiting	Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

Head and Neck Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT04313504	TSR-042	P2	completed	Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

Advanced Malignant Skin Neoplasm (1)

NCT	Acronym	Phase	Status	Title
NCT04387084	—	P1	active not recruiting	Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy

Pancreatic Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT04409002	—	P2	completed	Niraparib + Dostarlimab + RT in Pancreatic Cancer

Ovarian Carcinosarcoma (1)

NCT	Acronym	Phase	Status	Title
NCT03651206	ROCSAN	P2/P3	recruiting	Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

Melanoma Stage III (1)

NCT	Acronym	Phase	Status	Title
NCT04139902	TSR-042	P2	active not recruiting	Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma

Recurrent Cervix Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT04068753	STAR	P2	active not recruiting	Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer

Rectal Adenocarcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT04165772	—	P2	recruiting	Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors

Multiple Myeloma (1)

NCT	Acronym	Phase	Status	Title
NCT04126200	DREAMM 5	P1/P2	active not recruiting	Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Mesothelioma, Malignant (1)

NCT	Acronym	Phase	Status	Title
NCT03654833	MiST	P2	unknown	Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma

Ovarian Neoplasm (1)

NCT	Acronym	Phase	Status	Title
NCT05751629	COHORT-A	P2	completed	Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer

Breast Neoplasms (1)

NCT	Acronym	Phase	Status	Title
NCT01042379	I-SPY	P2	recruiting	I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Dostarlimab pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

Acronym	NCT	Phase	Status	Indication	Enrollment	PubMed
EC	NCT06897527	P4	not yet recruiting	Neoplasms, Endometrial	100	—
PREDIR-NEOREC	NCT06762405	P3	recruiting	Rectal Adenocarcinoma with Mismatch-repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H)	68	—
DOMENICA	NCT05201547	P3	active not recruiting	Endometrial Cancer	260	PMID 40966692
JADE	NCT06256588	P3	recruiting	Neoplasms, Head and Neck	864	PMID 41612885
FIRST	NCT03602859	P3	active not recruiting	Ovarian Neoplasms	1,400	—
COSTAR Lung	NCT04655976	P3	active not recruiting	Lung Cancer, Non-Small Cell	758	—
PD-L1	NCT06472076	P3	active not recruiting	Lung Cancer, Non-Small Cell	88	—
RUBY	NCT03981796	P3	active not recruiting	Neoplasms	785	PMID 37731489
NItCHE-MITO33	NCT04679064	P3	unknown	Ovarian Cancer	427	PMID 34607820
I-SPY	NCT01042379	P2	recruiting	Breast Neoplasms	5,000	PMID 21796368
China AZUR-1	NCT06640049	P2	active not recruiting	Neoplasms, Rectal	23	—
BeeHive	NCT07408063	P2	recruiting	Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma	30	—
RODEO	NCT07115927	P2	not yet recruiting	Endometrial Cancer	40	—
IMMUNOSTAR	NCT07381777	P2	not yet recruiting	Locally Advanced Rectal Cancer (LARC)	270	—
Pan-MSI-ACSE	NCT06333314	P2	recruiting	Pancreatic Adenocarcinoma	120	—
EC	NCT07108270	P2	recruiting	Neoplasms, Endometrial	30	—
DOVE	NCT06023862	P2	recruiting	Ovarian Neoplasms	198	PMID 39710508
STARLET	NCT05700721	P2	recruiting	Brain Metastases	120	—
TSR-042	NCT04139902	P2	active not recruiting	Melanoma Stage III	48	PMID 36648215
NADiR	NCT04837209	P2	active not recruiting	Breast Cancer	32	—
AZUR-1	NCT05723562	P2	active not recruiting	Neoplasms, Rectal	154	—
NADIA	NCT07013851	P2	not yet recruiting	MMRd/MSI-H Stage II-III Endometrial Cancer	25	—
NAIO	NCT05239546	P2	recruiting	Colon Cancer	25	—
PREDOSTAR	NCT05855811	P2	recruiting	Recurrent Cancer	400	—
Superhero	NCT06830239	P2	recruiting	Colon Cancer Stage III	10	—
AZUR-4	NCT06567782	P2	recruiting	Neoplasms, Colon	120	—
DEWI	NCT06059495	P2	recruiting	Adenocarcinoma - GEJ	59	—
SATELLITE	NCT06278857	P2	recruiting	Endometrial Cancer Stage I	10	PMID 39955187
DOVIPA	NCT06757244	P2	recruiting	Pancreas Neoplasms	35	—
RUBY-J	NCT06317311	P2	active not recruiting	Carcinoma	41	—
STAR	NCT04068753	P2	active not recruiting	Recurrent Cervix Cancer	66	—
TSR-042	NCT04313504	P2	completed	Head and Neck Cancer	10	—
UNITO-001	NCT04940637	P2	unknown	Lung Cancer	70	—
NIRADO	NCT04779151	P2	terminated	Urothelial Bladder Cancer	51	—
NSCLC	NCT04581824	P2	terminated	Lung Cancer, Non-Small Cell	243	PMID 41080090
NSCLC	NCT06926673	P2	completed	Neoplasms	62	—
NSCLC	NCT03739710	P2	completed	Neoplasms	175	—
MiST	NCT03654833	P2	unknown	Mesothelioma, Malignant	186	PMID 35157829
COHORT-A	NCT05751629	P2	completed	Ovarian Neoplasm	41	—
MOONSTONE	NCT03955471	P2	terminated	Ovarian Neoplasms	41	PMID 37890345
PD-1	NCT03308942	P2	completed	Neoplasms	53	PMID 34478166

Terminated and withdrawn Dostarlimab trials (12)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

NCT05405192withdrawnDostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia
NCT06365970withdrawnNiraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers
NCT05126342withdrawnStudy to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi
NCT06385548withdrawnEfficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer
NCT05980416terminatedStudy of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
NCT04544995terminatedDose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)
NCT04779151terminatedBasket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab
NCT04926324terminatedA Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers
NCT04581824terminatedEfficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
NCT06655818terminatedSub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Dostarlimab (GSK4057190) in Participants With RRMM
NCT04895046withdrawnMaintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma
NCT03955471terminatedStudy to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer

All Dostarlimab trials (87)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT ID	Acronym	Title	Phase	Status	Enrollment	Sponsor	Started
NCT01042379	I-SPY	I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer	P2	recruiting	5,000	QuantumLeap Healthcare Collaborative	Mar 2010
NCT06640049	China AZUR-1	A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China	P2	active not recruiting	23	GlaxoSmithKline	Oct 2024
NCT05855200		Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer	P3	recruiting	892	GlaxoSmithKline	Aug 2023
NCT07408063	BeeHive	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)	P2	recruiting	30	University Health Network, Toronto	Apr 2026
NCT07115927	RODEO	pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer	P2	not yet recruiting	40	University College, London	Sep 2025
NCT07381777	IMMUNOSTAR	XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients	P2	not yet recruiting	270	Gruppo Oncologico Italiano di Ricerca Clinica	Jan 2026
NCT07336147		Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma	P2	recruiting	45	Chang Gung Memorial Hospital	Dec 2025
NCT06762405	PREDIR-NEOREC	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	P3	recruiting	68	Centre Hospitalier Universitaire Dijon	Feb 2025
NCT06333314	Pan-MSI-ACSE	Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI	P2	recruiting	120	UNICANCER	Jul 2024
NCT07108270	EC	A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)	P2	recruiting	30	GlaxoSmithKline	Nov 2025
NCT06023862	DOVE	A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)	P2	recruiting	198	Yonsei University	Jan 2024
NCT05700721	STARLET	Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)	P2	recruiting	120	M.D. Anderson Cancer Center	Jun 2023
NCT04139902	TSR-042	Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma	P2	active not recruiting	48	Diwakar Davar	Jun 2020
NCT04837209	NADiR	Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer	P2	active not recruiting	32	Massachusetts General Hospital	Jul 2021
NCT05201547	DOMENICA	Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line	P3	active not recruiting	260	ARCAGY/ GINECO GROUP	Apr 2022
NCT06256588	JADE	A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma	P3	recruiting	864	GlaxoSmithKline	Mar 2024
NCT05723562	AZUR-1	A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer	P2	active not recruiting	154	GlaxoSmithKline	Apr 2023
NCT06405230	PDL1	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)	P1/P2	recruiting	40	GlaxoSmithKline	Dec 2025
NCT07013851	NADIA	Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer	P2	not yet recruiting	25	Grupo Español de Investigación en Cáncer de Ovario	Oct 2025
NCT04584255		Niraparib + Dostarlimab In BRCA Mutated Breast Cancer	P2	active not recruiting	62	Dana-Farber Cancer Institute	Dec 2020
NCT05239546	NAIO	Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers	P2	recruiting	25	University of Iowa	Mar 2023
NCT06551142	PanTumor-101	A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)	P1	recruiting	845	GlaxoSmithKline	Sep 2024
NCT03602859	FIRST	A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer	P3	active not recruiting	1,400	Tesaro, Inc.	Oct 2018
NCT05784012	RADIAN	Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma	P1/P2	active not recruiting	34	Grupo Español de Tratamiento de Tumores de Cabeza y Cuello	Nov 2023
NCT03651206	ROCSAN	Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib	P2/P3	recruiting	138	ARCAGY/ GINECO GROUP	Jul 2020
NCT05855811	PREDOSTAR	PREventing Second Cancers With DOSTARlimab	P2	recruiting	400	Centre Leon Berard	Jul 2023
NCT06830239	Superhero	Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer	P2	recruiting	10	Universitaire Ziekenhuizen KU Leuven	Apr 2025
NCT05405192		Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia	P2	withdrawn	0	University of Miami	Mar 2023
NCT06567782	AZUR-4	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	P2	recruiting	120	GlaxoSmithKline	Feb 2025
NCT06796907	BEHOLD-2	A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors	P1/P2	recruiting	305	GlaxoSmithKline	Mar 2025
NCT06059495	DEWI	Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study	P2	recruiting	59	GERCOR - Multidisciplinary Oncology Cooperative Group	Dec 2023
NCT06278857	SATELLITE	SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)	P2	recruiting	10	Queensland Centre for Gynaecological Cancer	Aug 2024
NCT05819892		Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer	P1	recruiting	21	M.D. Anderson Cancer Center	Jul 2023
NCT06757244	DOVIPA	DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer	P2	recruiting	35	Hopital Foch	Feb 2025
NCT06879717	PULMO-01	A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients	P1/P2	active not recruiting	45	iOnctura	Apr 2025
NCT06365970		Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers	P2	withdrawn	0	Ibrahim Halil Sahin	Jan 2025
NCT07269249	RW-NEDOS	Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer	—	recruiting	50	National Cancer Institute, Naples	Sep 2025
NCT06062420		A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202	P2	active not recruiting	316	GlaxoSmithKline	Nov 2023
NCT05526989		Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma	P2	recruiting	25	H. Lee Moffitt Cancer Center and Research Institute	Dec 2022
NCT06065462		Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100	P1/P2	recruiting	21	M.D. Anderson Cancer Center	Nov 2023
NCT06317311	RUBY-J	A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer	P2	active not recruiting	41	GlaxoSmithKline	May 2024
NCT05277051		First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors	P1	active not recruiting	152	GlaxoSmithKline	Mar 2022
NCT04387084		Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy	P1	active not recruiting	10	University of Southern California	Aug 2020
NCT04068753	STAR	Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer	P2	active not recruiting	66	University of Oklahoma	Feb 2020
NCT06238635		Dostarlimab and Cobolimab in Advanced Cervical Cancer	P2	active not recruiting	66	Meghan Shea	Mar 2024
NCT05559879		Cabozantinib and Dostarlimab in Recurrent Gynecologic Carcinosarcoma	P1/P2	recruiting	37	University of Alabama at Birmingham	Aug 2023
NCT04701307		Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas	P2	active not recruiting	48	M.D. Anderson Cancer Center	Feb 2021
NCT04655976	COSTAR Lung	Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy	P3	active not recruiting	758	GlaxoSmithKline	Dec 2020
NCT04126200	DREAMM 5	Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)	P1/P2	active not recruiting	208	GlaxoSmithKline	Oct 2019
NCT04774419		Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery	P2	recruiting	62	Memorial Sloan Kettering Cancer Center	Apr 2021
NCT05565378		A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer	P2	active not recruiting	351	GlaxoSmithKline	Oct 2022
NCT06472076	PD-L1	A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)	P3	active not recruiting	88	GlaxoSmithKline	Jun 2024
NCT02715284	GARNET	Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors	P1	active not recruiting	730	Tesaro, Inc.	Mar 2016
NCT06897527	EC	A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)	P4	not yet recruiting	100	GlaxoSmithKline	Jul 2025
NCT05646082	STARKAP	Preliminary Assessment of Safety and Tolerability of Dostarlimab in Combination Antiretroviral Therapy (cART) Refractory HIV Associated Kaposi Sarcoma	P1	active not recruiting	15	Imperial College London	May 2023
NCT04446351		Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors	P1	active not recruiting	107	GlaxoSmithKline	Jun 2020
NCT04165772		Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors	P2	recruiting	212	Memorial Sloan Kettering Cancer Center	Dec 2019
NCT03981796	RUBY	A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer	P3	active not recruiting	785	Tesaro, Inc.	Jul 2019
NCT05126342		Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi	P2	withdrawn	0	AGO Research GmbH	Nov 2023
NCT06521567		A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer	P1/P2	active not recruiting	83	GlaxoSmithKline	Mar 2025
NCT04673448		Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer	P1	active not recruiting	18	University of Washington	Oct 2021
NCT05870761		Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma	P2	active not recruiting	8	Casey Cosgrove	Oct 2023
NCT06385548	LiDer	Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer	P1/P2	withdrawn	0	Vall d'Hebron Institute of Oncology	May 2024
NCT03843359	FTIH	A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors	P1	active not recruiting	97	GlaxoSmithKline	Mar 2019
NCT04313504	TSR-042	Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC	P2	completed	10	Trisha Wise-Draper	Nov 2020
NCT05060432	TIG-006	Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	P1/P2	active not recruiting	153	iTeos Belgium SA	Sep 2021
NCT04940637	UNITO-001	UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC	P2	unknown	70	University of Turin, Italy	Dec 2020
NCT05065021		Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor	P2	unknown	40	University Health Network, Toronto	Feb 2023
NCT05980416		Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2	P1	terminated	88	Elevation Oncology	Aug 2023
NCT04493060		Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer	P2	completed	22	Mayo Clinic	Dec 2020
NCT04544995	SCOOP	Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)	P1	terminated	47	GlaxoSmithKline	Oct 2020
NCT04779151	NIRADO	Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab	P2	terminated	51	Gustave Roussy, Cancer Campus, Grand Paris	Apr 2021
NCT04679064	NItCHE-MITO33	Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment	P3	unknown	427	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Dec 2020
NCT04926324		A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers	P1/P2	terminated	3	University of Iowa	Jul 2022
NCT05728814	DORA	DOstarlimab in Patients With Recurrent or dMMR/MSI-H Endometrial Cancer	—	unknown	100	Grupo Español de Investigación en Cáncer de Ovario	Mar 2023
NCT04581824	NSCLC	Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)	P2	terminated	243	GlaxoSmithKline	Nov 2020
NCT06926673	NSCLC	Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 3	P2	completed	62	GlaxoSmithKline	Dec 2021
NCT03739710	NSCLC	Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)	P2	completed	175	GlaxoSmithKline	Jan 2019
NCT06655818	GSK2857916	Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Dostarlimab (GSK4057190) in Participants With RRMM	P1/P2	terminated	4	GlaxoSmithKline	Mar 2021
NCT03654833	MiST	Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma	P2	unknown	186	University of Leicester	Jan 2019
NCT04895046		Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma	P2	withdrawn	0	Walid Shaib, MD	Oct 2021
NCT02723955	INDUCE-1	Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)	P1	completed	829	GlaxoSmithKline	Jun 2016
NCT03250832	CITRINO	Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors	P1	completed	111	Tesaro, Inc.	Aug 2017
NCT05751629	COHORT-A	Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer	P2	completed	41	Tesaro, Inc.	Nov 2018
NCT04409002		Niraparib + Dostarlimab + RT in Pancreatic Cancer	P2	completed	18	Massachusetts General Hospital	Jul 2020
NCT03955471	MOONSTONE	Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer	P2	terminated	41	Tesaro, Inc.	Oct 2019
NCT03308942	PD-1	Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants	P2	completed	53	Tesaro, Inc.	Sep 2017

Dostarlimab clinical trials: frequently asked questions

How many Dostarlimab clinical trials are there?: 87 Dostarlimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 28 are actively recruiting participants. 9 are marked completed.
Are Dostarlimab clinical trials recruiting in 2026?: Yes — 28 Dostarlimab trials are actively recruiting in 2026, with 133 U.S. sites across 34 states. See the recruiting trials and the per-state site list further down this page.
What conditions is Dostarlimab being studied for?: Dostarlimab is being studied for Neoplasms, Endometrial Cancer, Lung Cancer, Non-Small Cell, Ovarian Neoplasms, Breast Cancer and 162 more. The trials are grouped by indication on this page.
What phase is Dostarlimab in?: Dostarlimab clinical trials span 1 Phase 4, 9 Phase 3, 49 Phase 2, 13 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Dostarlimab clinical trials?: The lead sponsor across the most Dostarlimab trials is GlaxoSmithKline, with 46 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Dostarlimabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

Last refreshed June 12, 2026.

Related pages on Hipa.ai:

Dostarlimab overview Dostarlimab evidence & publications