Table Info

Table 2.

Trials of dostarlimab

Phase	Trial code	Cancer type	Participants	Sponsor	Purpose of study	Current status	Completion date
Phase 2	NCT04068753	Recurrent cervix cancer	65	University of Oklahoma	To evaluate the safety of dostarlimab and niraparib used in combination therapy and determine the effects (both positive and negative) that this therapy has on individuals with progressive or recurrent cervix cancer	Recruiting	July 2025
Phase 2	NCT05405192	GTN	24	University of Miami	To determine whether Dostarlimab is a successful therapy for GTN	Not yet recruiting	December 1, 2028
Phase 2	NCT04313504	Head and neck cancer	23	Trisha Wise-Draper	To identify which niraparib and dostarlimab combination provides individuals with recurrent or metastatic HNSCC with the greatest overall outcome	Recruiting	June 1, 2027
Phase 1	NCT04544995	Neoplasms	116	GSK	To identify the optimal Phase 2 dose and assess the safety, PK, and effectiveness of niraparib combined with dostarlimab in children with resistant or recurrent solid tumours	Recruiting	March 15, 2030
Phase 2	NCT04139902	Melanoma stage III; melanoma stage IV	56	Diwakar Davar	To evaluate the efficacy of anti-PD-1/anti-TIM-3 (TSR-042/TSR-022) or anti-PI-1 inhibitor (TSR-042) combo in operable melanoma patients	Recruiting	October 2027
Phase 2	NCT04409002	Pancreatic cancer; metastatic pancreatic cancer	25	Massachusetts General Hospital	To examines the efficacy of RT, niraparib, and dostarlimab in the treatment of metastatic pancreatic cancer	Active, not recruiting	October 1, 2026
Phase 2 Phase 3	NCT04655976	Lung cancer, non-small cell	250	GSK	To see how cobolimab combined with docetaxel and dostarlimab works in individuals with NSCLC who have developed on the previous anti-PD-L1 treatment and chemotherapy	Recruiting	January 1, 2026
Phase 2	NCT04701307	Lung small cell carcinoma	48	MD Anderson Cancer Center	To investigate the efficacy of dostarlimab and niraparib in the treatment of SCLC	Recruiting	May 30, 2025
Phase 3	NCT05201547	Endometrial cancer	142	Arcagy-Gineco GROUP	To compare effectiveness of dostarlimab to carboplatin-paclitaxel in advanced endometrial cancer or dMMR relapse patients	Recruiting	May 2029
Phase 2	NCT03955471	Ovarian neoplasms	41	Tesaro, Inc.	To assess the safety and efficacy of dostarlimab and niraparib in patients with relapsed, advanced, fallopian tube, endometrioid, high-grade ovarian, clear cell, or primary peritoneal cancer who do not have a known BRCA mutation, have a platinum-resistant disease, and have also undergone bevacizumab treatment in the past	Terminated	January 12, 2022
Phase 2	NCT05126342	Recurrent ovarian cancer	100	AGO Research GmbH	To gather proof of the effectiveness of dostarlimab and niraparib in two experimental cohorts of relapsed ovarian cancer patients	Not yet recruiting	November 1, 2026
Phase 2	NCT04581824	Lung cancer, non-small cell	243	GSK	To compare the safety and effectiveness of the PD-1 inhibitors pembrolizumab and dostarlimab when given along with chemotherapy to patients with non-squamous NSCLC who do not have a known sensitizing ALK, EGFR, ROS-1, BRAF V600E mutation	Active, not recruiting	October 20, 2025
Phase 1 Phase 2	NCT04926324	Rectal neoplasm malignant	38	Joseph Caster, Ph.D., M.D.	To establish the maximum tolerable dose of niraparib for locally advanced rectal cancer when treated with dostarlimab and hypofractionated radiotherapy	Recruiting	December 31, 2026
Phase 2	NCT04983745	Homologous recombination deficient solid tumours	30	West Cancer Center	To assess the dostarlimab and niraparib effectiveness and safety in metastatic, recurrent, or unresectable solid tumours patients that have a suspected pathogenic, pathogenic, somatic HRD gene mutation	Not yet recruiting	August 2025
Phase 2	NCT04493060	Metastatic pancreatic ductal adenocarcinoma	20	Mayo Clinic	To evaluate the efficacy of dostarlimab and niraparib in the treatment of individuals with germline or somatic PALB2 and BRCA1/2 mutant pancreatic cancer that has progressed to other parts of the body	Recruiting	December 1, 2022
Phase 3	NCT04679064	Ovarian cancer	427	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	To compare chemotherapy given at the doctor’s discretion with niraparib plus dostarlimab in the treatment of patients with primary peritoneal cancer when platinum is not an option	Recruiting	January 1, 2025
Phase 2	NCT04895046	HRD; cholangiocarcinoma; metastatic cancer	47	Walid Shaib, M.D.	To evaluate HRD patient selection in molecularly chosen immune-based combination therapy for advanced cholangiocarcinoma maintenance therapies	Withdrawn	September 2023
Phase 2	NCT04837209	Breast cancer	32	Massachusetts General Hospital	To evaluate the safety and efficacy of niraparib and dostarlimab in combination with RT in patients with metastatic triple-negative breast cancer	Recruiting	December 1, 2029
Phase 2	NCT03680508	Adult primary liver cancer	42	University of Hawaii	To examine the efficacy of dostarlimab and cobolimab in treating locally advanced or metastatic liver cancer patients	Recruiting	October 2023
Phase 1	NCT02715284	Neoplasms	740	Tesaro, Inc.	To assess the dostarlimab in advanced solid tumour patients who have few other alternatives for therapy	Recruiting	July 30, 2024
Phase 2	NCT04681469	HNSCC	49	Gruppo Oncologico del Nord-Ovest	To assess the effectiveness and safety of a short course of the drug combination dostarlimab and niraparib	Recruiting	June 2028
Phase 1	NCT03843359	Neoplasms	300	GSK	To assess the tolerability, safety, and early clinical efficacy of GSK3745417 whether given alone (Part 1A) or in combination (Part 2A) with dostarlimab in refractory/relapsed solid tumours patients	Recruiting	May 22, 2025
Phase 2	NCT04584255	Breast cancer	62	Dana-Farber Cancer Institute	To evaluate the safety and efficacy of using dostarlimab plus niraparib as a neoadjuvant treatment for BRCA-mutated breast cancer patients	Recruiting	July 17, 2029
Phase 3	NCT03602859	Ovarian neoplasms	1405	Tesaro, Inc.	To compare the effectiveness of dostarlimab and niraparib for platinum-based therapy with platinum-based therapy as the standard of care for treating stage III or stage IV nonmucinous epithelial ovarian cancer	Active, not recruiting	June 22, 2026
Phase 1	NCT04446351	Neoplasms	178	GSK	To assess GSK6097608’s safety, tolerability, PD, PK, and preliminary clinical efficacy in advanced solid tumour patients when it is administered alone and in combination with dostarlimab	Recruiting	August 29, 2024
Phase 2	NCT04165772	Rectal adeno carcinoma	30	Memorial Sloan Kettering Cancer Center	To investigate the efficacy of dostarlimab as a treatment for advanced dMMR solid tumours in comparison to standard surgery and standard chemoradiotherapy (capecitabine + RT)	Recruiting	November 30, 2025
Phase 2	NCT03308942	Neoplasms	53	Tesaro, Inc.	To assess the effectiveness and safety of niraparib in combination and alone with PD-1 inhibitors in patients with metastatic and locally advanced NSCLC	Completed	August 31, 2021
Phase 1	NCT05277051	Neoplasms	126	GSK	To examine the PK, safety, immunogenicity, and tolerability of GSK4381562 in certain metastatic or locoregionally recurrent solid tumours patients for whom no other effective or conventional treatment choices remain	Recruiting	February 26, 2027
Phase 1	NCT03250832	Neoplasms	111	Tesaro, Inc.	To assess the TSR-033 alone and in combination with dostarlimab and combination with FOL/leucovorin, dostarlimab, 5-fluorouracil, and OX and bevacizumab in an individual with advanced solid tumours	Active, not recruiting	November 14, 2022
Phase 1	NCT04673448	Breast cancer	18	University of Washington	To assess the effectiveness of niraparib and TSR-042 in treating individuals with primary peritoneal, pancreas, fallopian tube BRCA-mutated breast, ovary cancer	Recruiting	March 30, 2026
Phase 1 Phase 2	NCT04126200	Multiple myeloma	464	GSK	To assess the impact of belantamab mafodotin in conjunction with other anti-cancer medications in refractory/relapsed multiple myeloma patients	Recruiting	February 23, 2028
Phase 2	NCT03016338	Endometrial cancer	51	University Health Network, Toronto	To determine the effectiveness of dostarlimab with the experimental medication niraparib in recurrent/advanced endometrial cancer patients	Active, not recruiting	December 2023
Phase 1 Phase 2	NCT05060432	Advanced cancer	376	iTeos Belgium SA	To assess EOS-448’s safety, RP2D, tolerability, pharmacodynamics, PK, and anticancer efficacy in patients with advanced solid tumours who are receiving routine medical treatment and experimental medicines	Recruiting	September 2024

BRAF: B-Raf proto-oncogene, serine/threonine kinase; BRCA: breast cancer; EGFR: epidermal growth factor receptor; GTN: gestational trophoblastic neoplasia; HRD: homologous recombination deficiency; OX: oxaliplatin; PALB: partner and localizer of breast cancer 2; FOL: folinic acid; ROS-1: c-ros oncogene 1; RP2D: recommended phase 2 dose; RT: radiation therapy; TSR: anticancer treatment being developed by Tesaro to treat various types of cancer

Declarations

Acknowledgments

The authors are very thankful to the management of ISF College of Pharmacy, Moga, Punjab, for being supportive.

Author contributions

RA: Conceptualization. SAV: Data curation. PAC: Writing—review & editing.

Conflicts of interest

The authors declare that they have no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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