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AzTrials

Ovarian NeoplasmsPhase 3FIRSTNCT03602859

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

A Phase 3 study testing Niraparib and Dostarlimab (TSR-042) in people with Ovarian Neoplasms and Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma, run by Tesaro, Inc. at 182 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Niraparib and Dostarlimab (TSR-042)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,400 participants
Where
182 sitesin 19 countries
Study dates
11 Oct 2018to 30 Apr 2029
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

182 sites in 19 countries.

182 sites in 19 countries

United States65 sites

  • GSK Investigational Site

    Anchorage, Alaska, 99508

  • GSK Investigational Site

    Austin, Texas, 78731

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Billings, Montana, 59101

  • GSK Investigational Site

    Boston, Massachusetts, 02215

  • GSK Investigational Site

    Canton, Ohio, 44710

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Charlottesville, Virginia, 22903

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Covington, Louisiana, 70433

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Eugene, Oregon, 97401

  • GSK Investigational Site

    Farmington, Connecticut, 06030

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Gainesville, Florida, 32608

  • GSK Investigational Site

    Geneva, Illinois, 60555

  • GSK Investigational Site

    Hartford, Connecticut, 06102

  • GSK Investigational Site

    Hawthorne, New York, 10532

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Jacksonville, Florida, 32256

  • GSK Investigational Site

    Kennewick, Washington, 99336

  • GSK Investigational Site

    Knoxville, Tennessee, 37920

  • GSK Investigational Site

    Los Angeles, California, 90027

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Minneapolis, Minnesota, 55404

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Nashville, Tennessee, 37205

  • GSK Investigational Site

    Neptune City, New Jersey, 07753

  • GSK Investigational Site

    New Orleans, Louisiana, 70121

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    New York, New York, 10065

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Ogden, Utah, 84405

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Paoli, Pennsylvania, 19301

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111

  • GSK Investigational Site

    Phoenix, Arizona, 85016

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15224

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • GSK Investigational Site

    Portland, Oregon, 97227

  • GSK Investigational Site

    Providence, Rhode Island, 02905

  • GSK Investigational Site

    Rochester, New York, 14620-4159

  • GSK Investigational Site

    San Antonio, Texas, 78240

  • GSK Investigational Site

    Scarborough, Maine, 04074

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Seattle, Washington, 98109

  • GSK Investigational Site

    Shreveport, Louisiana, 71103

  • GSK Investigational Site

    Silver Spring, Maryland, 20910

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105

  • GSK Investigational Site

    Springfield, Massachusetts, 01199

  • GSK Investigational Site

    Stony Brook, New York, 11794

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Teaneck, New Jersey, 07666

  • GSK Investigational Site

    The Woodlands, Texas, 77380

  • GSK Investigational Site

    Tucson, Arizona, 85711

  • GSK Investigational Site

    Tyler, Texas, 75702

  • GSK Investigational Site

    Warrenville, Illinois, 60555

  • GSK Investigational Site

    Willow Grove, Pennsylvania, 19001-3788

  • GSK Investigational Site

    Worcester, Massachusetts, 01605

  • GSK Investigational Site

    Wynnewood, Pennsylvania, 19096

  • GSK Investigational Site

    Zion, Illinois, 60099

Other trials in United States

France39 sites

  • GSK Investigational Site

    Angers, 49055

  • GSK Investigational Site

    Avignon, 84918

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Bordeaux, 33000

  • GSK Investigational Site

    Bron, 69495

  • GSK Investigational Site

    Caen, 14000

  • GSK Investigational Site

    Cholet, 69373

  • GSK Investigational Site

    Clermont-Ferrand, 63011

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Grenoble, 38000

  • GSK Investigational Site

    Grenoble, 38700

  • GSK Investigational Site

    Le Mans, 72000

  • GSK Investigational Site

    Lille, 59000

  • GSK Investigational Site

    Lyon, 69008

  • GSK Investigational Site

    Lyon, 69373

  • GSK Investigational Site

    Lyon, 69495

  • GSK Investigational Site

    Marseille, 13273

  • GSK Investigational Site

    Montpellier, 34070

  • GSK Investigational Site

    Montpellier, 34298

  • GSK Investigational Site

    Nancy, 54100

  • GSK Investigational Site

    Nantes, 44227

  • GSK Investigational Site

    Nice, 06189

  • GSK Investigational Site

    Nîmes, 30029

  • GSK Investigational Site

    Paris, 75014

  • GSK Investigational Site

    Paris, 75020

  • GSK Investigational Site

    Paris, 75248

  • GSK Investigational Site

    Paris, 75908

  • GSK Investigational Site

    Paris, 75970

  • GSK Investigational Site

    Pierre-Bénite, 69495

  • GSK Investigational Site

    Plerin-sur-mer, 22190

  • GSK Investigational Site

    Poitiers, 86021

  • GSK Investigational Site

    Reims, 51056

  • GSK Investigational Site

    Rennes, 35042

  • GSK Investigational Site

    Saint-Cloud, 75248

  • GSK Investigational Site

    Saint-Priest-en-Jarez, 42271

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Tours, 37044

  • GSK Investigational Site

    Villejuif, 94805

Other trials in France

Spain11 sites

  • GSK Investigational Site

    Ávila, 05071

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Girona, 17007

  • GSK Investigational Site

    Jaén, 23007

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid, 28702

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Toledo, 45007

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

Canada7 sites

  • GSK Investigational Site

    London, Ontario, N6A 4L6

  • GSK Investigational Site

    Montreal, Quebec, H2X 3E4

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 4E6

  • GSK Investigational Site

    Windsor, 1000

Other trials in Canada

Germany6 sites

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Hamburg, 22457

  • GSK Investigational Site

    Kiel, 24103

  • GSK Investigational Site

    Münster, 48149

  • GSK Investigational Site

    Ravensburg, 88212

  • GSK Investigational Site

    Wolfsburg, 38440

Other trials in Germany

Israel6 sites

  • GSK Investigational Site

    Beersheba, 8410101

  • GSK Investigational Site

    Haifa, 3109601

  • GSK Investigational Site

    Haifa, 3436212

  • GSK Investigational Site

    Holon, 5822012

  • GSK Investigational Site

    Petah Tikva, 4941492

  • GSK Investigational Site

    Rehovot, 76100

Other trials in Israel

Netherlands6 sites

  • GSK Investigational Site

    Amsterdam, 1081 HV

  • GSK Investigational Site

    Groningen, 9700 RB

  • GSK Investigational Site

    Maastricht, 6229 HX

  • GSK Investigational Site

    Nijmegen, 6525 GA

  • GSK Investigational Site

    Rotterdam, 3015 GD

  • GSK Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

Romania6 sites

  • GSK Investigational Site

    Bucharest, 022328

  • GSK Investigational Site

    Cluj-Napoca, 400015

  • GSK Investigational Site

    Cluj-Napoca, 400051

  • GSK Investigational Site

    Constanța, 900591

  • GSK Investigational Site

    Craiova, 200347

  • GSK Investigational Site

    Timișoara, 300239

Other trials in Romania

Greece5 sites

  • GSK Investigational Site

    Athens, 115 28

  • GSK Investigational Site

    Athens, 11528

  • GSK Investigational Site

    Athens, 12462

  • GSK Investigational Site

    Haidari - Athens, 12462

  • GSK Investigational Site

    Marousi, 15123

Other trials in Greece

Italy5 sites

  • GSK Investigational Site

    Bologna, 40138

  • GSK Investigational Site

    Faenza, 48018

  • GSK Investigational Site

    Lugo RA, 48018

  • GSK Investigational Site

    Meldola FC, 47014

  • GSK Investigational Site

    Naples, 80131

Other trials in Italy

United Kingdom5 sites

  • GSK Investigational Site

    Glasgow, G12 0YN

  • GSK Investigational Site

    Metropolitan Borough of Wirral, CH63 4JY

  • GSK Investigational Site

    Portsmouth, PO6 3LY

  • GSK Investigational Site

    Sutton, SM2 5PT

  • GSK Investigational Site

    Truro, TR1 3LJ

Other trials in United Kingdom

Finland4 sites

  • GSK Investigational Site

    Helsinki, 00029

  • GSK Investigational Site

    Kuopio, 70210

  • GSK Investigational Site

    Tampere, 33520

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Denmark3 sites

  • GSK Investigational Site

    Copenhagen, DK- 2100

  • GSK Investigational Site

    Herlev, 2730

  • GSK Investigational Site

    Roskilde, 4000

Other trials in Denmark

Norway3 sites

  • GSK Investigational Site

    Kristiansand, 4632

  • GSK Investigational Site

    Oslo, 0310

  • GSK Investigational Site

    Tromsø, 9019

Other trials in Norway

Poland3 sites

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Szczecin, 70-111

  • GSK Investigational Site

    Warsaw, 02-781

Other trials in Poland

Ukraine3 sites

  • GSK Investigational Site

    Chernihiv, 14029

  • GSK Investigational Site

    Kharkiv, 61024

  • GSK Investigational Site

    Lviv, 79031

Other trials in Ukraine

Belgium2 sites

  • GSK Investigational Site

    Brasschaat, 2930

  • GSK Investigational Site

    Bruges, 8000

Other trials in Belgium

Czechia2 sites

  • GSK Investigational Site

    Prague, 128 51

  • GSK Investigational Site

    Prague, 180 81

Other trials in Czechia

Belarus1 site

  • GSK Investigational Site

    Minsk, 223040

Other trials in Belarus

About this study

Official title: 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.

Being tested
Niraparib, Dostarlimab (TSR-042), Standard of care, Dostarlimab-Placebo, Niraparib-Placebo
Keywords
FIRST, FIRST trial, Niraparib, Dostarlimab (TSR-042), Ovarian cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Also called ZEJULA

    Participants will receive oral capsules of niraparib as a unit dosage strength of 100 milligrams (mg)

  • Dostarlimab (TSR-042)Drug

    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

  • Standard of careDrug

    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.

  • Dostarlimab-PlaceboDrug

    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

  • Niraparib-PlaceboDrug

    Participants will receive oral capsules of niraparib-placebo as a unit dosage strength of 100 mg.

Study groups in NCT03602859
Study groupRoleWhat they receive
Participants receiving SOC+placeboPlacebo comparatorParticipants 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
Receives: Drug: Standard of care; Drug: Dostarlimab-Placebo; Drug: Niraparib-Placebo
Participants receiving SOC+niraparibActive comparatorParticipants 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
Receives: Drug: Niraparib; Drug: Standard of care; Drug: Dostarlimab-Placebo
Participants receiving SOC+dostarlimab+niraparibExperimentalParticipants 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
Receives: Drug: Niraparib; Drug: Dostarlimab (TSR-042); Drug: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    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).

    Measured: Up to approximately 316 weeks

Secondary outcomes (12)

  1. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from the date of randomization to the date of death by any cause.

    Measured: Up to approximately 316 weeks

  2. PFS Determined by Blinded Independent Central Review (BICR) Per RECIST v1.1 Criteria

    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.

    Measured: Up to approximately 316 weeks

  3. Time to First Subsequent Therapy (TFST)

    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.

    Measured: Up to approximately 316 weeks

  4. Time to Second Subsequent Therapy (TSST)

    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.

    Measured: Up to approximately 316 weeks

  5. Time to Second Progression (PFS2)

    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).

    Measured: Up to approximately 316 weeks

  6. Objective Response Rate (ORR)

    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.

    Measured: Up to approximately 316 weeks

  7. Duration of Response (DOR)

    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.

    Measured: Up to approximately 316 weeks

  8. Disease Control Rate (DCR)

    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.

    Measured: Up to approximately 316 weeks

  9. Number of Participants With Treatment Emergent Positive Antidrug Antibodies (ADAs) of Dostarlimab

    Serum samples were collected for the analysis of Anti-drug antibody (ADAs) of dostarlimab.

    Measured: Up to approximately 316 weeks

  10. 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

    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).

    Measured: 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)

  11. Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)

    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.

    Measured: 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)

  12. Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire

    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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2018
  2. Study start11 Oct 2018
  3. Primary completion31 Oct 2024
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03602859
Sponsor's protocol ID
213350
Other IDs
2024-510605-28
Acronym
FIRST
Status last verified
Dec 2025
First submitted
28 Jun 2018
Last updated
31 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Niraparib and Dostarlimab (TSR-042) in people with Ovarian Neoplasms and Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma, run by Tesaro, Inc. at 182 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States, France, Spain, Canada, Germany and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to approximately 316 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03602859.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.

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