Trials of dostarlimab

PhaseTrial codeCancer typeParticipantsSponsorPurpose of studyCurrent statusCompletion date
Phase 2NCT04068753Recurrent cervix cancer65University of OklahomaTo 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 cancerRecruitingJuly 2025
Phase 2NCT05405192GTN24University of MiamiTo determine whether Dostarlimab is a successful therapy for GTNNot yet recruitingDecember 1, 2028
Phase 2NCT04313504Head and neck cancer23Trisha Wise-DraperTo identify which niraparib and dostarlimab combination provides individuals with recurrent or metastatic HNSCC with the greatest overall outcomeRecruitingJune 1, 2027
Phase 1NCT04544995Neoplasms116GSKTo 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 tumoursRecruitingMarch 15, 2030
Phase 2NCT04139902Melanoma stage III; melanoma stage IV56Diwakar DavarTo 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 patientsRecruitingOctober 2027
Phase 2NCT04409002Pancreatic cancer; metastatic pancreatic cancer25Massachusetts General HospitalTo examines the efficacy of RT, niraparib, and dostarlimab in the treatment of metastatic pancreatic cancerActive, not recruitingOctober 1, 2026
Phase 2 Phase 3NCT04655976Lung cancer, non-small cell250GSKTo see how cobolimab combined with docetaxel and dostarlimab works in individuals with NSCLC who have developed on the previous anti-PD-L1 treatment and chemotherapyRecruitingJanuary 1, 2026
Phase 2NCT04701307Lung small cell carcinoma48MD Anderson Cancer CenterTo investigate the efficacy of dostarlimab and niraparib in the treatment of SCLCRecruitingMay 30, 2025
Phase 3NCT05201547Endometrial cancer142Arcagy-Gineco GROUPTo compare effectiveness of dostarlimab to carboplatin-paclitaxel in advanced endometrial cancer or dMMR relapse patientsRecruitingMay 2029
Phase 2NCT03955471Ovarian neoplasms41Tesaro, 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 pastTerminatedJanuary 12, 2022
Phase 2NCT05126342Recurrent ovarian cancer100AGO Research GmbHTo gather proof of the effectiveness of dostarlimab and niraparib in two experimental cohorts of relapsed ovarian cancer patientsNot yet recruitingNovember 1, 2026
Phase 2NCT04581824Lung cancer, non-small cell243GSKTo 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 mutationActive, not recruitingOctober 20, 2025
Phase 1 Phase 2NCT04926324Rectal neoplasm malignant38Joseph Caster, Ph.D., M.D.To establish the maximum tolerable dose of niraparib for locally advanced rectal cancer when treated with dostarlimab and hypofractionated radiotherapyRecruitingDecember 31, 2026
Phase 2NCT04983745Homologous recombination deficient solid tumours30West Cancer CenterTo 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 mutationNot yet recruitingAugust 2025
Phase 2NCT04493060Metastatic pancreatic ductal adenocarcinoma20Mayo ClinicTo 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 bodyRecruitingDecember 1, 2022
Phase 3NCT04679064Ovarian cancer427Fondazione Policlinico Universitario Agostino Gemelli IRCCSTo 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 optionRecruitingJanuary 1, 2025
Phase 2NCT04895046HRD; cholangiocarcinoma; metastatic cancer47Walid Shaib, M.D.To evaluate HRD patient selection in molecularly chosen immune-based combination therapy for advanced cholangiocarcinoma maintenance therapiesWithdrawnSeptember 2023
Phase 2NCT04837209Breast cancer32Massachusetts General HospitalTo evaluate the safety and efficacy of niraparib and dostarlimab in combination with RT in patients with metastatic triple-negative breast cancerRecruitingDecember 1, 2029
Phase 2NCT03680508Adult primary liver cancer42University of HawaiiTo examine the efficacy of dostarlimab and cobolimab in treating locally advanced or metastatic liver cancer patientsRecruitingOctober 2023
Phase 1NCT02715284Neoplasms740Tesaro, Inc.To assess the dostarlimab in advanced solid tumour patients who have few other alternatives for therapyRecruitingJuly 30, 2024
Phase 2NCT04681469HNSCC49Gruppo Oncologico del Nord-OvestTo assess the effectiveness and safety of a short course of the drug combination dostarlimab and niraparibRecruitingJune 2028
Phase 1NCT03843359Neoplasms300GSKTo 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 patientsRecruitingMay 22, 2025
Phase 2NCT04584255Breast cancer62Dana-Farber Cancer InstituteTo evaluate the safety and efficacy of using dostarlimab plus niraparib as a neoadjuvant treatment for BRCA-mutated breast cancer patientsRecruitingJuly 17, 2029
Phase 3NCT03602859Ovarian neoplasms1405Tesaro, 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 cancerActive, not recruitingJune 22, 2026
Phase 1NCT04446351Neoplasms178GSKTo 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 dostarlimabRecruitingAugust 29, 2024
Phase 2NCT04165772Rectal adeno carcinoma30Memorial Sloan Kettering Cancer CenterTo investigate the efficacy of dostarlimab as a treatment for advanced dMMR solid tumours in comparison to standard surgery and standard chemoradiotherapy (capecitabine + RT)RecruitingNovember 30, 2025
Phase 2NCT03308942Neoplasms53Tesaro, Inc.To assess the effectiveness and safety of niraparib in combination and alone with PD-1 inhibitors in patients with metastatic and locally advanced NSCLCCompletedAugust 31, 2021
Phase 1NCT05277051Neoplasms126GSKTo 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 remainRecruitingFebruary 26, 2027
Phase 1NCT03250832Neoplasms111Tesaro, 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 tumoursActive, not recruitingNovember 14, 2022
Phase 1NCT04673448Breast cancer18University of WashingtonTo assess the effectiveness of niraparib and TSR-042 in treating individuals with primary peritoneal, pancreas, fallopian tube BRCA-mutated breast, ovary cancerRecruitingMarch 30, 2026
Phase 1 Phase 2NCT04126200Multiple myeloma464GSKTo assess the impact of belantamab mafodotin in conjunction with other anti-cancer medications in refractory/relapsed multiple myeloma patientsRecruitingFebruary 23, 2028
Phase 2NCT03016338Endometrial cancer51University Health Network, TorontoTo determine the effectiveness of dostarlimab with the experimental medication niraparib in recurrent/advanced endometrial cancer patientsActive, not recruitingDecember 2023
Phase 1
Phase 2
NCT05060432Advanced cancer376iTeos Belgium SATo 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 medicinesRecruitingSeptember 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