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 (FIRST)

December 9, 2025 updated by: Tesaro, Inc.

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

Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare the progression-free survival (PFS) for participants receiving dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus participants receiving SOC with chemotherapy followed by niraparib maintenance. This comparison will be investigated in participants of newly diagnosed stage III or IV advanced non-mucinous epithelial ovarian cancer participants and also to compare PFS of all participants with Stage III or IV high-grade non-mucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab (TSR-042), and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 223040
        • GSK Investigational Site
  • Belgium
      • Brasschaat, Belgium, 2930
        • GSK Investigational Site
      • Bruges, Belgium, 8000
        • GSK Investigational Site
  • Canada
      • Windsor, Canada, 1000
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • GSK Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2X 3E4
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • GSK Investigational Site
  • Czechia
      • Prague, Czechia, 128 51
        • GSK Investigational Site
      • Prague, Czechia, 180 81
        • GSK Investigational Site
  • Denmark
      • Copenhagen, Denmark, DK- 2100
        • GSK Investigational Site
      • Herlev, Denmark, 2730
        • GSK Investigational Site
      • Roskilde, Denmark, 4000
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • GSK Investigational Site
      • Kuopio, Finland, 70210
        • GSK Investigational Site
      • Tampere, Finland, 33520
        • GSK Investigational Site
      • Turku, Finland, 20520
        • GSK Investigational Site
  • France
      • Angers, France, 49055
        • GSK Investigational Site
      • Avignon, France, 84918
        • GSK Investigational Site
      • Besançon, France, 25030
        • GSK Investigational Site
      • Bordeaux, France, 33000
        • GSK Investigational Site
      • Bron, France, 69495
        • GSK Investigational Site
      • Caen, France, 14000
        • GSK Investigational Site
      • Cholet, France, 69373
        • GSK Investigational Site
      • Clermont-Ferrand, France, 63011
        • GSK Investigational Site
      • Dijon, France, 21079
        • GSK Investigational Site
      • Grenoble, France, 38000
        • GSK Investigational Site
      • Grenoble, France, 38700
        • GSK Investigational Site
      • Le Mans, France, 72000
        • GSK Investigational Site
      • Lille, France, 59000
        • GSK Investigational Site
      • Lyon, France, 69008
        • GSK Investigational Site
      • Lyon, France, 69495
        • GSK Investigational Site
      • Lyon, France, 69373
        • GSK Investigational Site
      • Marseille, France, 13273
        • GSK Investigational Site
      • Montpellier, France, 34298
        • GSK Investigational Site
      • Montpellier, France, 34070
        • GSK Investigational Site
      • Nancy, France, 54100
        • GSK Investigational Site
      • Nantes, France, 44227
        • GSK Investigational Site
      • Nice, France, 06189
        • GSK Investigational Site
      • Nîmes, France, 30029
        • GSK Investigational Site
      • Paris, France, 75014
        • GSK Investigational Site
      • Paris, France, 75020
        • GSK Investigational Site
      • Paris, France, 75970
        • GSK Investigational Site
      • Paris, France, 75908
        • GSK Investigational Site
      • Paris, France, 75248
        • GSK Investigational Site
      • Pierre-Bénite, France, 69495
        • GSK Investigational Site
      • Plerin-sur-mer, France, 22190
        • GSK Investigational Site
      • Poitiers, France, 86021
        • GSK Investigational Site
      • Reims, France, 51056
        • GSK Investigational Site
      • Rennes, France, 35042
        • GSK Investigational Site
      • Saint-Cloud, France, 75248
        • GSK Investigational Site
      • Saint-Priest-en-Jarez, France, 42271
        • GSK Investigational Site
      • Strasbourg, France, 67091
        • GSK Investigational Site
      • Toulouse, France, 31059
        • GSK Investigational Site
      • Tours, France, 37044
        • GSK Investigational Site
      • Villejuif, France, 94805
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Hamburg, Germany, 22457
        • GSK Investigational Site
      • Kiel, Germany, 24103
        • GSK Investigational Site
      • Münster, Germany, 48149
        • GSK Investigational Site
      • Ravensburg, Germany, 88212
        • GSK Investigational Site
      • Wolfsburg, Germany, 38440
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 115 28
        • GSK Investigational Site
      • Athens, Greece, 11528
        • GSK Investigational Site
      • Athens, Greece, 12462
        • GSK Investigational Site
      • Haidari - Athens, Greece, 12462
        • GSK Investigational Site
      • Marousi, Greece, 15123
        • GSK Investigational Site
  • Israel
      • Beersheba, Israel, 8410101
        • GSK Investigational Site
      • Haifa, Israel, 3109601
        • GSK Investigational Site
      • Haifa, Israel, 3436212
        • GSK Investigational Site
      • Holon, Israel, 5822012
        • GSK Investigational Site
      • Petah Tikva, Israel, 4941492
        • GSK Investigational Site
      • Rehovot, Israel, 76100
        • GSK Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • GSK Investigational Site
      • Faenza, Italy, 48018
        • GSK Investigational Site
      • Lugo RA, Italy, 48018
        • GSK Investigational Site
      • Meldola FC, Italy, 47014
        • GSK Investigational Site
      • Napoli, Italy, 80131
        • GSK Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • GSK Investigational Site
      • Groningen, Netherlands, 9700 RB
        • GSK Investigational Site
      • Maastricht, Netherlands, 6229 HX
        • GSK Investigational Site
      • Nijmegen, Netherlands, 6525 GA
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3015 GD
        • GSK Investigational Site
      • Utrecht, Netherlands, 3584 CX
        • GSK Investigational Site
  • Norway
      • Kristiansand, Norway, 4632
        • GSK Investigational Site
      • Oslo, Norway, 0310
        • GSK Investigational Site
      • Tromsø, Norway, 9019
        • GSK Investigational Site
  • Poland
      • Olsztyn, Poland, 10-228
        • GSK Investigational Site
      • Szczecin, Poland, 70-111
        • GSK Investigational Site
      • Warsaw, Poland, 02-781
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 022328
        • GSK Investigational Site
      • Cluj-Napoca, Romania, 400015
        • GSK Investigational Site
      • Cluj-Napoca, Romania, 400051
        • GSK Investigational Site
      • Constanța, Romania, 900591
        • GSK Investigational Site
      • Craiova, Romania, 200347
        • GSK Investigational Site
      • Timișoara, Romania, 300239
        • GSK Investigational Site
  • Spain
      • Badalona, Spain, 08916
        • GSK Investigational Site
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Girona, Spain, 17007
        • GSK Investigational Site
      • Jaén, Spain, 23007
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Madrid, Spain, 28702
        • GSK Investigational Site
      • Santiago de Compostela, Spain, 15706
        • GSK Investigational Site
      • Toledo, Spain, 45007
        • GSK Investigational Site
      • Valencia, Spain, 46010
        • GSK Investigational Site
      • Zaragoza, Spain, 50009
        • GSK Investigational Site
      • Ávila, Spain, 05071
        • GSK Investigational Site
  • Ukraine
      • Chernihiv, Ukraine, 14029
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61024
        • GSK Investigational Site
      • Lviv, Ukraine, 79031
        • GSK Investigational Site
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • GSK Investigational Site
      • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
        • GSK Investigational Site
      • Portsmouth, United Kingdom, PO6 3LY
        • GSK Investigational Site
      • Sutton, United Kingdom, SM2 5PT
        • GSK Investigational Site
      • Truro, United Kingdom, TR1 3LJ
        • GSK Investigational Site
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85711
        • GSK Investigational Site
    • California
      • Los Angeles, California, United States, 90027
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Newport Beach, California, United States, 92663
        • GSK Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • GSK Investigational Site
      • Hartford, Connecticut, United States, 06102
        • GSK Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32608
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32256
        • GSK Investigational Site
    • Illinois
      • Geneva, Illinois, United States, 60555
        • GSK Investigational Site
      • Warrenville, Illinois, United States, 60555
        • GSK Investigational Site
      • Zion, Illinois, United States, 60099
        • GSK Investigational Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70121
        • GSK Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • GSK Investigational Site
    • Maine
      • Scarborough, Maine, United States, 04074
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • GSK Investigational Site
      • Silver Spring, Maryland, United States, 20910
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • GSK Investigational Site
      • Springfield, Massachusetts, United States, 01199
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01605
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • GSK Investigational Site
      • Minneapolis, Minnesota, United States, 55455
        • GSK Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • GSK Investigational Site
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • GSK Investigational Site
      • Teaneck, New Jersey, United States, 07666
        • GSK Investigational Site
    • New York
      • Hawthorne, New York, United States, 10532
        • GSK Investigational Site
      • New York, New York, United States, 10065
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
      • New York, New York, United States, 10029
        • GSK Investigational Site
      • Rochester, New York, United States, 14620-4159
        • GSK Investigational Site
      • Stony Brook, New York, United States, 11794
        • GSK Investigational Site
      • Syracuse, New York, United States, 13210
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44710
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Portland, Oregon, United States, 97227
        • GSK Investigational Site
    • Pennsylvania
      • Paoli, Pennsylvania, United States, 19301
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19111
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • GSK Investigational Site
      • Willow Grove, Pennsylvania, United States, 19001-3788
        • GSK Investigational Site
      • Wynnewood, Pennsylvania, United States, 19096
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • GSK Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • GSK Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37205
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • GSK Investigational Site
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78240
        • GSK Investigational Site
      • The Woodlands, Texas, United States, 77380
        • GSK Investigational Site
      • Tyler, Texas, United States, 75702
        • GSK Investigational Site
    • Utah
      • Ogden, Utah, United States, 84405
        • GSK Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • GSK Investigational Site
      • Norfolk, Virginia, United States, 23502
        • GSK Investigational Site
    • Washington
      • Kennewick, Washington, United States, 99336
        • GSK Investigational Site
      • Seattle, Washington, United States, 98104
        • GSK Investigational Site
      • Seattle, Washington, United States, 98109
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Participants must be female, >=18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.
  • Participants with a histologically confirmed diagnosis of high-grade nonmucinous epithelial ovarian (serous, endometrioid, clear cell, carcinosarcoma, and mixed pathologies), fallopian tube, or peritoneal cancer that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria.
  • All participants with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo primary debulking surgery (PDS) (R0 or macroscopic disease), or those for whom neoadjuvant chemotherapy (NACT) is planned.
  • Participants with Stage III are eligible if they meet protocol defined criteria.
  • Participants must provide a blood sample for circulating tumor deoxyribonucleic acid (ctDNA) homologous recombinant repair (HRR) testing at pre-screening or screening.
  • Participant must provide a minimum of 1 formalin-fixed paraffin embedded (FFPE) block slide at pre-screening or screening for PD-L1, homologous recombinant deficiency (HRD) testing.
  • Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin) within 3 days prior to receiving the first dose of study treatment.
  • Participants must be postmenopausal, free from menses for >1 year, surgically sterilized, or willing to use highly effective contraception to prevent pregnancy or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through 180 days after the last dose of study treatment.
  • Participants must have adequate organ function: Absolute neutrophil count (ANC) >=1500/micro liter (μL;) Platelet count >=100000/μL; Hemoglobin >=9 grams per deciliter (g/dL); Serum creatinine <=1.5 × upper limit of normal (ULN) or calculated creatinine clearance >=60 milliliters per minute (mL/min) using the Cockcroft-Gault equation; total bilirubin <=1.5 × ULN or direct bilirubin <=1.5 × ULN; AST and ALT <=2.5 × ULN unless liver metastases are present, in which case they must be <=5 × ULN.
  • Participants must have an ECOG score of 0 or 1.
  • Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP <=140 millimeters of mercury (mmHg) and/or diastolic BP <=90 mmHg).
  • Participants must agree to complete health related quality of life (HRQoL) questionnaires throughout the study.
  • Participants must be able to take oral medication.

Exclusion Criteria:

  • Participant has mucinous, germ cell, transitional cell, or undifferentiated tumor.
  • Participant has low-grade or Grade 1 epithelial ovarian cancer.
  • Participant has not adequately recovered from prior major surgery.
  • Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use, during niraparib treatment and for 30 days after receiving the final dose of study treatment).
  • Participant has known active central nervous system metastases, carcinomatous meningitis, or both.
  • Participant has clinically significant cardiovascular disease.
  • Participant has a bowel obstruction by clinical symptoms or computed tomography (CT) scan, subocclusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess.
  • Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Participant has been diagnosed and/or treated with any therapy for invasive cancer <5 years from study enrollment, completed adjuvant chemotherapy and/or targeted therapy (example, trastuzumab) less than 3 years from enrollment, or completed adjuvant hormonal therapy less than 4 weeks from enrollment.
  • Participants with definitively treated non-invasive malignancies such as cervical carcinoma in situ, ductal carcinoma in situ, Grade 1 or 2, Stage I endometrial cancer, or non-melanomatous skin cancer are allowed.
  • Participant is at increased bleeding risk due to concurrent conditions (example, major injuries or major surgery within the past 28 days prior to start of study treatment and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
  • Participant is immunocompromised.
  • Participant has known active hepatitis B (example, hepatitis B surface antigen reactive) or hepatitis C (example, hepatitis C virus ribonucleic acid [qualitative] is detected).
  • Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or uncontrolled infection.
  • Participant has had investigational therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
  • Participant has received a live vaccine within 14 days of planned start of study therapy. Seasonal influenza vaccines that do not contain live viruses are allowed.
  • Participant has a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, dostarlimab, or their excipients.
  • Prior treatment for high-grade nonmucinous epithelial ovarian, fallopian tube, or peritoneal cancer (immunotherapy, anti-cancer therapy, radiation therapy).
  • Participant has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (example, thyroid hormone or insulin).
  • Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Participants receiving SOC+placebo
Participants in this arm will receive SOC (carboplatin+paclitaxel+/-bevacizumab) in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment with dostarlimab placebo from cycles 2 to 6 and maintenance treatment of +/-bevacizumab along with niraparib placebo and dostarlimab placebo
Drug: Standard of care
Participants will receive SOC that includes paclitaxel 175 milligrams per square meter (mg/m^2) on day 1 every 21 days + carboplatin area under the curve (AUC) of 5 to 6 milligrams per milliliter per minute (mg/mL/min) on day 1 every 21 days +/- bevacizumab 7.5 milligrams per kilograms (mg/kg) every 21 days or 15 mg/kg every 21 days for a total of 15 months.
Drug: Niraparib-Placebo
Participants will receive oral capsules of niraparib-placebo as a unit dosage strength of 100 mg.
Drug: Dostarlimab-Placebo
Participants will receive 500 mg of dostarlimab-placebo on day 1 every 3 weeks from cycle 2 to 6 followed by 1000 mg of dostarlimab-placebo on day 1 every 6 weeks to continue up to 3 years in the absence of disease progression, unacceptable toxicity, participant withdrawal, or investigator decision
Active Comparator: Participants receiving SOC+niraparib
Participants in this arm will receive SOC in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment dostarlimab placebo from cycles 2 to 6 and maintenance treatment of +/- bevacizumab with niraparib and dostarlimab placebo
Drug: Standard of care
Participants will receive SOC that includes paclitaxel 175 milligrams per square meter (mg/m^2) on day 1 every 21 days + carboplatin area under the curve (AUC) of 5 to 6 milligrams per milliliter per minute (mg/mL/min) on day 1 every 21 days +/- bevacizumab 7.5 milligrams per kilograms (mg/kg) every 21 days or 15 mg/kg every 21 days for a total of 15 months.
Drug: Dostarlimab-Placebo
Participants will receive 500 mg of dostarlimab-placebo on day 1 every 3 weeks from cycle 2 to 6 followed by 1000 mg of dostarlimab-placebo on day 1 every 6 weeks to continue up to 3 years in the absence of disease progression, unacceptable toxicity, participant withdrawal, or investigator decision
Drug: Niraparib
Participants will receive oral capsules of niraparib as a unit dosage strength of 100 milligrams (mg)
Other Names:
  • ZEJULA
Experimental: Participants receiving SOC+dostarlimab+niraparib
Participants in this arm will receive SOC in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment dostarlimab, and maintenance treatment of +/-bevacizumab with niraparib and dostarlimab
Drug: Standard of care
Participants will receive SOC that includes paclitaxel 175 milligrams per square meter (mg/m^2) on day 1 every 21 days + carboplatin area under the curve (AUC) of 5 to 6 milligrams per milliliter per minute (mg/mL/min) on day 1 every 21 days +/- bevacizumab 7.5 milligrams per kilograms (mg/kg) every 21 days or 15 mg/kg every 21 days for a total of 15 months.
Drug: Niraparib
Participants will receive oral capsules of niraparib as a unit dosage strength of 100 milligrams (mg)
Other Names:
  • ZEJULA
Drug: Dostarlimab (TSR-042)
Participants will receive 500 mg dostarlimab on day 1 every 3 weeks from cycle 2 to 6 followed by 1000mg of dostarlimab on day 1 every 6 weeks to continue up to 3 years in the absence of disease progression, unacceptable toxicity, participant withdrawal, or investigator decision

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to approximately 316 weeks
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first by the Investigator assessment according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm).
Up to approximately 316 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 316 weeks
Overall Survival (OS) is defined as the time from the date of randomization to the date of death by any cause.
Up to approximately 316 weeks
PFS Determined by Blinded Independent Central Review (BICR) Per RECIST v1.1 Criteria
Time Frame: Up to approximately 316 weeks
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first determined by the BICR according to RECIST version 1.1. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Up to approximately 316 weeks
Time to First Subsequent Therapy (TFST)
Time Frame: Up to approximately 316 weeks
Time to First Subsequent Therapy (TFST) is defined as the time from randomization until the start date of the first subsequent anticancer therapy or death by any cause, whichever occurs first. First subsequent anticancer therapy is defined as the earliest anticancer therapy on the follow-up anticancer therapy form.
Up to approximately 316 weeks
Time to Second Subsequent Therapy (TSST)
Time Frame: Up to approximately 316 weeks
Time to Second Subsequent Therapy (TSST) is defined as the time from the date of randomization to the start date of the second subsequent anticancer therapy or death of any cause, whichever occurs first. Second subsequent anticancer therapy is defined as an anticancer therapy with a start date after the first subsequent anticancer therapy and a recorded PD on first subsequent anticancer therapy, as captured on the follow-up anticancer therapy eCRF form.
Up to approximately 316 weeks
Time to Second Progression (PFS2)
Time Frame: Up to approximately 316 weeks

PFS2 is defined as the time from the date of randomization to the date of first Progressive Disease per Investigator's assessment after initiation of subsequent anticancer therapy or death due to any cause, whichever occurs first.

Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm).
Up to approximately 316 weeks
Objective Response Rate (ORR)
Time Frame: Up to approximately 316 weeks
Objective Response Rate (ORR) is defined as the percentage of participants with measurable disease at baseline achieving a best overall response (BOR) of complete response (CR) or partial response (PR) by Investigator assessment per RECIST v1.1 criteria for participants with measurable disease at baseline. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm.
Up to approximately 316 weeks
Duration of Response (DOR)
Time Frame: Up to approximately 316 weeks
DOR is defined as the time from the first documented response (complete response (CR) OR partial response (PR) ) to the first documented disease progression per Investigator assessed RECIST v1.1 or death by any cause in participants with measurable disease at baseline who responded to treatment. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.
Up to approximately 316 weeks
Disease Control Rate (DCR)
Time Frame: Up to approximately 316 weeks
Disease Control Rate (DCR) is defined as the percentage of participants with measurable disease at baseline achieving a best overall response (BOR) of complete response (CR), partial response (PR) or stable disease (SD) by Investigator assessment per RECIST v1.1 criteria for participants with measurable disease at baseline. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions. SD defined as any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm.
Up to approximately 316 weeks
Number of Participants With Treatment Emergent Positive Antidrug Antibodies (ADAs) of Dostarlimab
Time Frame: Up to approximately 316 weeks
Serum samples were collected for the analysis of Anti-drug antibody (ADAs) of dostarlimab.
Up to approximately 316 weeks
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
Time Frame: Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months)
EQ-5D-5L is a standardized, participant-rated health outcomes questionnaire covering five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each of dimensions, participant self-assigned score: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems); 5 (extreme problems). VAS is collected separately and recorded from 0 (Worst imaginable health state) to 100 (Best imaginable health state). HUI values summarize how good or bad each health state is on a scale of 1 (full health) to 0 (worse health/dead). High HUI value indicates a good HRQoL. Baseline is defined as the latest, non-missing collected value, excluding end of treatment, safety follow-up, long term follow-up visits records and unscheduled visits after end of treatment (EOT).
Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months)
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Time Frame: Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months)
The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology.
Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months)
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
Time Frame: Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months)
The EORTC QLQ-OV28 supplements the QLQ-C30. It includes three functional scales (body image (BI), sexuality (S), attitude to disease/treatment(ATD)) and five symptom scales/items (abdominal/GI symptoms (AS), peripheral neuropathy (PN), hormonal/menopausal symptoms (MS), other chemotherapy side effects (CSE), and hair loss (HS)). Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much). Higher scores represent better functioning (better quality of life). For functional scales: improved (worsened) is defined as >=10 points increase (decrease) from baseline. For symptom scales: improved (worsened) is defined as >=10 points decrease (increase) from baseline. Baseline is defined as the latest, non-missing collected value, excluding end of treatment, safety follow-up, long term follow-up visits records and unscheduled visits after end of treatment.
Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tesaro, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 213350
  • 2024-510605-28 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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