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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,402

Participants

Timeline

Start Date

October 11, 2018

Primary Completion Date

October 31, 2024

Study Completion Date

June 22, 2026

Conditions
Ovarian NeoplasmsOvarian, Fallopian Tube and Primary Peritoneal Carcinoma
Interventions
DRUG

Niraparib

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

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

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-Placebo

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

Trial Locations (180)

1000

GSK Investigational Site, Windsor

2730

GSK Investigational Site, Herlev

2930

GSK Investigational Site, Brasschaat

4000

GSK Investigational Site, Roskilde

4632

GSK Investigational Site, Kristiansand

8000

GSK Investigational Site, Bruges

9019

GSK Investigational Site, Tromsø

10016

GSK Investigational Site, New York

10029

GSK Investigational Site, New York

10065

GSK Investigational Site, New York

10532

GSK Investigational Site, Hawthorne

11528

GSK Investigational Site, Athens

11794

GSK Investigational Site, Stony Brook

12462

GSK Investigational Site, Athens

GSK Investigational Site, Haidari - Athens

13125

GSK Investigational Site, Berlin

13210

GSK Investigational Site, Syracuse

13273

GSK Investigational Site, Marseille

14000

GSK Investigational Site, Caen

14029

GSK Investigational Site, Chernihiv

15123

GSK Investigational Site, Marousi

15224

GSK Investigational Site, Pittsburgh

15232

GSK Investigational Site, Pittsburgh

15706

GSK Investigational Site, Santiago de Compostela

17007

GSK Investigational Site, Girona

19096

GSK Investigational Site, Wynnewood

19111

GSK Investigational Site, Philadelphia

19301

GSK Investigational Site, Paoli

20520

GSK Investigational Site, Turku

20910

GSK Investigational Site, Silver Spring

21079

GSK Investigational Site, Dijon

21201

GSK Investigational Site, Baltimore

22190

GSK Investigational Site, Plerin-sur-mer

22457

GSK Investigational Site, Hamburg

22903

GSK Investigational Site, Charlottesville

23007

GSK Investigational Site, Jaén

23502

GSK Investigational Site, Norfolk

25030

GSK Investigational Site, Besançon

28046

GSK Investigational Site, Madrid

28204

GSK Investigational Site, Charlotte

28702

GSK Investigational Site, Madrid

29425

GSK Investigational Site, Charleston

30029

GSK Investigational Site, Nîmes

31059

GSK Investigational Site, Toulouse

32256

GSK Investigational Site, Jacksonville

32608

GSK Investigational Site, Gainesville

33000

GSK Investigational Site, Bordeaux

33520

GSK Investigational Site, Tampere

34070

GSK Investigational Site, Montpellier

34298

GSK Investigational Site, Montpellier

35042

GSK Investigational Site, Rennes

37044

GSK Investigational Site, Tours

37203

GSK Investigational Site, Nashville

37205

GSK Investigational Site, Nashville

37920

GSK Investigational Site, Knoxville

38000

GSK Investigational Site, Grenoble

38440

GSK Investigational Site, Wolfsburg

38700

GSK Investigational Site, Grenoble

40138

GSK Investigational Site, Bologna

42271

GSK Investigational Site, Saint-Priest-en-Jarez

44227

GSK Investigational Site, Nantes

44710

GSK Investigational Site, Canton

45007

GSK Investigational Site, Toledo

45219

GSK Investigational Site, Cincinnati

46010

GSK Investigational Site, Valencia

47014

GSK Investigational Site, Meldola FC

48018

GSK Investigational Site, Faenza

GSK Investigational Site, Lugo RA

48149

GSK Investigational Site, Münster

49055

GSK Investigational Site, Angers

51056

GSK Investigational Site, Reims

54100

GSK Investigational Site, Nancy

55109

GSK Investigational Site, Maplewood

55404

GSK Investigational Site, Minneapolis

55455

GSK Investigational Site, Minneapolis

57105

GSK Investigational Site, Sioux Falls

59000

GSK Investigational Site, Lille

59101

GSK Investigational Site, Billings

60099

GSK Investigational Site, Zion

60555

GSK Investigational Site, Geneva

GSK Investigational Site, Warrenville

63011

GSK Investigational Site, Clermont-Ferrand

67091

GSK Investigational Site, Strasbourg

69008

GSK Investigational Site, Lyon

69373

GSK Investigational Site, Cholet

GSK Investigational Site, Lyon

69495

GSK Investigational Site, Bron

GSK Investigational Site, Lyon

GSK Investigational Site, Pierre-Bénite

70121

GSK Investigational Site, New Orleans

70210

GSK Investigational Site, Kuopio

70433

GSK Investigational Site, Covington

71103

GSK Investigational Site, Shreveport

72000

GSK Investigational Site, Le Mans

73104

GSK Investigational Site, Oklahoma City

75014

GSK Investigational Site, Paris

75020

GSK Investigational Site, Paris

75246

GSK Investigational Site, Dallas

75248

GSK Investigational Site, Paris

GSK Investigational Site, Saint-Cloud

75702

GSK Investigational Site, Tyler

75908

GSK Investigational Site, Paris

75970

GSK Investigational Site, Paris

76100

GSK Investigational Site, Rehovot

76104

GSK Investigational Site, Fort Worth

77030

GSK Investigational Site, Houston

77380

GSK Investigational Site, The Woodlands

78240

GSK Investigational Site, San Antonio

78731

GSK Investigational Site, Austin

79031

GSK Investigational Site, Lviv

80131

GSK Investigational Site, Napoli

84405

GSK Investigational Site, Ogden

84918

GSK Investigational Site, Avignon

85016

GSK Investigational Site, Phoenix

85711

GSK Investigational Site, Tucson

86021

GSK Investigational Site, Poitiers

88212

GSK Investigational Site, Ravensburg

90027

GSK Investigational Site, Los Angeles

90048

GSK Investigational Site, Los Angeles

92663

GSK Investigational Site, Newport Beach

94805

GSK Investigational Site, Villejuif

97227

GSK Investigational Site, Portland

97401

GSK Investigational Site, Eugene

98104

GSK Investigational Site, Seattle

98109

GSK Investigational Site, Seattle

99336

GSK Investigational Site, Kennewick

99508

GSK Investigational Site, Anchorage

200347

GSK Investigational Site, Craiova

223040

GSK Investigational Site, Minsk

300239

GSK Investigational Site, Timișoara

400015

GSK Investigational Site, Cluj-Napoca

400051

GSK Investigational Site, Cluj-Napoca

900591

GSK Investigational Site, Constanța

3109601

GSK Investigational Site, Haifa

3436212

GSK Investigational Site, Haifa

4941492

GSK Investigational Site, Petah Tikva

5822012

GSK Investigational Site, Holon

8410101

GSK Investigational Site, Beersheba

06030

GSK Investigational Site, Farmington

06102

GSK Investigational Site, Hartford

04074

GSK Investigational Site, Scarborough

02215

GSK Investigational Site, Boston

01199

GSK Investigational Site, Springfield

01605

GSK Investigational Site, Worcester

07753

GSK Investigational Site, Neptune City

07666

GSK Investigational Site, Teaneck

14620-4159

GSK Investigational Site, Rochester

19001-3788

GSK Investigational Site, Willow Grove

02905

GSK Investigational Site, Providence

V5Z 4E6

GSK Investigational Site, Vancouver

N6A 4L6

GSK Investigational Site, London

M4N 3M5

GSK Investigational Site, Toronto

H2X 3E4

GSK Investigational Site, Montreal

H4A 3J1

GSK Investigational Site, Montreal

J1H 5N4

GSK Investigational Site, Sherbrooke

128 51

GSK Investigational Site, Prague

180 81

GSK Investigational Site, Prague

DK- 2100

GSK Investigational Site, Copenhagen

00029

GSK Investigational Site, Helsinki

06189

GSK Investigational Site, Nice

115 28

GSK Investigational Site, Athens

1081 HV

GSK Investigational Site, Amsterdam

9700 RB

GSK Investigational Site, Groningen

6229 HX

GSK Investigational Site, Maastricht

6525 GA

GSK Investigational Site, Nijmegen

3015 GD

GSK Investigational Site, Rotterdam

3584 CX

GSK Investigational Site, Utrecht

0310

GSK Investigational Site, Oslo

10-228

GSK Investigational Site, Olsztyn

70-111

GSK Investigational Site, Szczecin

02-781

GSK Investigational Site, Warsaw

022328

GSK Investigational Site, Bucharest

05071

GSK Investigational Site, Ávila

08916

GSK Investigational Site, Badalona

08036

GSK Investigational Site, Barcelona

G12 0YN

GSK Investigational Site, Glasgow

CH63 4JY

GSK Investigational Site, Metropolitan Borough of Wirral

PO6 3LY

GSK Investigational Site, Portsmouth

SM2 5PT

GSK Investigational Site, Sutton

TR1 3LJ

GSK Investigational Site, Truro

All Listed Sponsors
collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

lead

Tesaro, Inc.

INDUSTRY