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New drug cocktail shows promise in battle against advanced ovarian cancer

NCT ID NCT03602859

Disease control Sponsor: Tesaro, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding two newer drugs (dostarlimab and niraparib) to standard chemotherapy helps people with advanced ovarian cancer live longer without their cancer growing. About 1,400 participants with stage III or IV ovarian cancer will receive either the standard treatment or the standard treatment plus the two extra drugs. The goal is to see if the new combination delays cancer progression better than current care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,400 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fallopian tube serous adenocarcinoma ovarian cancer ovarian carcinoma ovarian neoplasm primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian neoplasms Ovarian, fallopian tube and primary peritoneal carcinoma

Contacts and locations

Locations

  • GSK Investigational Site

    Anchorage, Alaska, 99508, United States

  • GSK Investigational Site

    Phoenix, Arizona, 85016, United States

  • GSK Investigational Site

    Tucson, Arizona, 85711, United States

  • GSK Investigational Site

    Los Angeles, California, 90027, United States

  • GSK Investigational Site

    Los Angeles, California, 90048, United States

  • GSK Investigational Site

    Newport Beach, California, 92663, United States

  • GSK Investigational Site

    Farmington, Connecticut, 06030, United States

  • GSK Investigational Site

    Hartford, Connecticut, 06102, United States

  • GSK Investigational Site

    Gainesville, Florida, 32608, United States

  • GSK Investigational Site

    Jacksonville, Florida, 32256, United States

  • GSK Investigational Site

    Geneva, Illinois, 60555, United States

  • GSK Investigational Site

    Warrenville, Illinois, 60555, United States

  • GSK Investigational Site

    Zion, Illinois, 60099, United States

  • GSK Investigational Site

    Covington, Louisiana, 70433, United States

  • GSK Investigational Site

    New Orleans, Louisiana, 70121, United States

  • GSK Investigational Site

    Shreveport, Louisiana, 71103, United States

  • GSK Investigational Site

    Scarborough, Maine, 04074, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21201, United States

  • GSK Investigational Site

    Silver Spring, Maryland, 20910, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02215, United States

  • GSK Investigational Site

    Springfield, Massachusetts, 01199, United States

  • GSK Investigational Site

    Worcester, Massachusetts, 01605, United States

  • GSK Investigational Site

    Minneapolis, Minnesota, 55404, United States

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455, United States

  • GSK Investigational Site

    Billings, Montana, 59101, United States

  • GSK Investigational Site

    Neptune City, New Jersey, 07753, United States

  • GSK Investigational Site

    Teaneck, New Jersey, 07666, United States

  • GSK Investigational Site

    Hawthorne, New York, 10532, United States

  • GSK Investigational Site

    New York, New York, 10016, United States

  • GSK Investigational Site

    New York, New York, 10029, United States

  • GSK Investigational Site

    New York, New York, 10065, United States

  • GSK Investigational Site

    Rochester, New York, 14620-4159, United States

  • GSK Investigational Site

    Stony Brook, New York, 11794, United States

  • GSK Investigational Site

    Syracuse, New York, 13210, United States

  • GSK Investigational Site

    Charlotte, North Carolina, 28204, United States

  • GSK Investigational Site

    Canton, Ohio, 44710, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45219, United States

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104, United States

  • GSK Investigational Site

    Eugene, Oregon, 97401, United States

  • GSK Investigational Site

    Portland, Oregon, 97227, United States

  • GSK Investigational Site

    Paoli, Pennsylvania, 19301, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15224, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15232, United States

  • GSK Investigational Site

    Willow Grove, Pennsylvania, 19001-3788, United States

  • GSK Investigational Site

    Wynnewood, Pennsylvania, 19096, United States

  • GSK Investigational Site

    Providence, Rhode Island, 02905, United States

  • GSK Investigational Site

    Charleston, South Carolina, 29425, United States

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105, United States

  • GSK Investigational Site

    Knoxville, Tennessee, 37920, United States

  • GSK Investigational Site

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    Nashville, Tennessee, 37205, United States

  • GSK Investigational Site

    Austin, Texas, 78731, United States

  • GSK Investigational Site

    Dallas, Texas, 75246, United States

  • GSK Investigational Site

    Fort Worth, Texas, 76104, United States

  • GSK Investigational Site

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    San Antonio, Texas, 78240, United States

  • GSK Investigational Site

    The Woodlands, Texas, 77380, United States

  • GSK Investigational Site

    Tyler, Texas, 75702, United States

  • GSK Investigational Site

    Ogden, Utah, 84405, United States

  • GSK Investigational Site

    Charlottesville, Virginia, 22903, United States

  • GSK Investigational Site

    Norfolk, Virginia, 23502, United States

  • GSK Investigational Site

    Kennewick, Washington, 99336, United States

  • GSK Investigational Site

    Seattle, Washington, 98104, United States

  • GSK Investigational Site

    Seattle, Washington, 98109, United States

  • GSK Investigational Site

    Minsk, 223040, Belarus

  • GSK Investigational Site

    Brasschaat, 2930, Belgium

  • GSK Investigational Site

    Bruges, 8000, Belgium

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 4E6, Canada

  • GSK Investigational Site

    London, Ontario, N6A 4L6, Canada

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2X 3E4, Canada

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4, Canada

  • GSK Investigational Site

    Windsor, 1000, Canada

  • GSK Investigational Site

    Prague, 128 51, Czechia

  • GSK Investigational Site

    Prague, 180 81, Czechia

  • GSK Investigational Site

    Copenhagen, DK- 2100, Denmark

  • GSK Investigational Site

    Herlev, 2730, Denmark

  • GSK Investigational Site

    Roskilde, 4000, Denmark

  • GSK Investigational Site

    Helsinki, 00029, Finland

  • GSK Investigational Site

    Kuopio, 70210, Finland

  • GSK Investigational Site

    Tampere, 33520, Finland

  • GSK Investigational Site

    Turku, 20520, Finland

  • GSK Investigational Site

    Angers, 49055, France

  • GSK Investigational Site

    Avignon, 84918, France

  • GSK Investigational Site

    Besançon, 25030, France

  • GSK Investigational Site

    Bordeaux, 33000, France

  • GSK Investigational Site

    Bron, 69495, France

  • GSK Investigational Site

    Caen, 14000, France

  • GSK Investigational Site

    Cholet, 69373, France

  • GSK Investigational Site

    Clermont-Ferrand, 63011, France

  • GSK Investigational Site

    Dijon, 21079, France

  • GSK Investigational Site

    Grenoble, 38000, France

  • GSK Investigational Site

    Grenoble, 38700, France

  • GSK Investigational Site

    Le Mans, 72000, France

  • GSK Investigational Site

    Lille, 59000, France

  • GSK Investigational Site

    Lyon, 69008, France

  • GSK Investigational Site

    Lyon, 69373, France

  • GSK Investigational Site

    Lyon, 69495, France

  • GSK Investigational Site

    Marseille, 13273, France

  • GSK Investigational Site

    Montpellier, 34070, France

  • GSK Investigational Site

    Montpellier, 34298, France

  • GSK Investigational Site

    Nancy, 54100, France

  • GSK Investigational Site

    Nantes, 44227, France

  • GSK Investigational Site

    Nice, 06189, France

  • GSK Investigational Site

    Nîmes, 30029, France

  • GSK Investigational Site

    Paris, 75014, France

  • GSK Investigational Site

    Paris, 75020, France

  • GSK Investigational Site

    Paris, 75248, France

  • GSK Investigational Site

    Paris, 75908, France

  • GSK Investigational Site

    Paris, 75970, France

  • GSK Investigational Site

    Pierre-Bénite, 69495, France

  • GSK Investigational Site

    Plerin-sur-mer, 22190, France

  • GSK Investigational Site

    Poitiers, 86021, France

  • GSK Investigational Site

    Reims, 51056, France

  • GSK Investigational Site

    Rennes, 35042, France

  • GSK Investigational Site

    Saint-Cloud, 75248, France

  • GSK Investigational Site

    Saint-Priest-en-Jarez, 42271, France

  • GSK Investigational Site

    Strasbourg, 67091, France

  • GSK Investigational Site

    Toulouse, 31059, France

  • GSK Investigational Site

    Tours, 37044, France

  • GSK Investigational Site

    Villejuif, 94805, France

  • GSK Investigational Site

    Berlin, 13125, Germany

  • GSK Investigational Site

    Hamburg, 22457, Germany

  • GSK Investigational Site

    Kiel, 24103, Germany

  • GSK Investigational Site

    Münster, 48149, Germany

  • GSK Investigational Site

    Ravensburg, 88212, Germany

  • GSK Investigational Site

    Wolfsburg, 38440, Germany

  • GSK Investigational Site

    Athens, 115 28, Greece

  • GSK Investigational Site

    Athens, 11528, Greece

  • GSK Investigational Site

    Athens, 12462, Greece

  • GSK Investigational Site

    Haidari - Athens, 12462, Greece

  • GSK Investigational Site

    Marousi, 15123, Greece

  • GSK Investigational Site

    Beersheba, 8410101, Israel

  • GSK Investigational Site

    Haifa, 3109601, Israel

  • GSK Investigational Site

    Haifa, 3436212, Israel

  • GSK Investigational Site

    Holon, 5822012, Israel

  • GSK Investigational Site

    Petah Tikva, 4941492, Israel

  • GSK Investigational Site

    Rehovot, 76100, Israel

  • GSK Investigational Site

    Bologna, 40138, Italy

  • GSK Investigational Site

    Faenza, 48018, Italy

  • GSK Investigational Site

    Lugo RA, 48018, Italy

  • GSK Investigational Site

    Meldola FC, 47014, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Amsterdam, 1081 HV, Netherlands

  • GSK Investigational Site

    Groningen, 9700 RB, Netherlands

  • GSK Investigational Site

    Maastricht, 6229 HX, Netherlands

  • GSK Investigational Site

    Nijmegen, 6525 GA, Netherlands

  • GSK Investigational Site

    Rotterdam, 3015 GD, Netherlands

  • GSK Investigational Site

    Utrecht, 3584 CX, Netherlands

  • GSK Investigational Site

    Kristiansand, 4632, Norway

  • GSK Investigational Site

    Oslo, 0310, Norway

  • GSK Investigational Site

    Tromsø, 9019, Norway

  • GSK Investigational Site

    Olsztyn, 10-228, Poland

  • GSK Investigational Site

    Szczecin, 70-111, Poland

  • GSK Investigational Site

    Warsaw, 02-781, Poland

  • GSK Investigational Site

    Bucharest, 022328, Romania

  • GSK Investigational Site

    Cluj-Napoca, 400015, Romania

  • GSK Investigational Site

    Cluj-Napoca, 400051, Romania

  • GSK Investigational Site

    Constanța, 900591, Romania

  • GSK Investigational Site

    Craiova, 200347, Romania

  • GSK Investigational Site

    Timișoara, 300239, Romania

  • GSK Investigational Site

    Ávila, 05071, Spain

  • GSK Investigational Site

    Badalona, 08916, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Girona, 17007, Spain

  • GSK Investigational Site

    Jaén, 23007, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Madrid, 28702, Spain

  • GSK Investigational Site

    Santiago de Compostela, 15706, Spain

  • GSK Investigational Site

    Toledo, 45007, Spain

  • GSK Investigational Site

    Valencia, 46010, Spain

  • GSK Investigational Site

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    Chernihiv, 14029, Ukraine

  • GSK Investigational Site

    Kharkiv, 61024, Ukraine

  • GSK Investigational Site

    Lviv, 79031, Ukraine

  • GSK Investigational Site

    Glasgow, G12 0YN, United Kingdom

  • GSK Investigational Site

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • GSK Investigational Site

    Portsmouth, PO6 3LY, United Kingdom

  • GSK Investigational Site

    Sutton, SM2 5PT, United Kingdom

  • GSK Investigational Site

    Truro, TR1 3LJ, United Kingdom

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Other studies related to the condition(s) this trial covers.