A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Tesaro, Inc.
Study ID
NCT03981796
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Neoplasms

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — BIOLOGICAL
    Participants will be administered dostarlimab
  • Placebo matching dostarlimab — DRUG
    Participants will be administered placebo matching dostarlimab
  • Carboplatin — DRUG
    Participants will be administered carboplatin
  • Paclitaxel — DRUG
    Participants will be administered paclitaxel
  • Niraparib — DRUG
    Participants will be administered niraparib
  • Placebo matching Niraparib — DRUG
    Participants will be administered placebo matching Niraparib

Study Details

This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo; and Part 2 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced (Stage III or IV) endometrial cancer.

Key Dates

Start date
Jul 18, 2019
Status verified
Sep 2025
Primary completion
Nov 26, 2026
Completion
Nov 26, 2026

Study Design

Enrollment
785 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab
  • Placebo Comparator: Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
  • Active Comparator: Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
  • Placebo Comparator: Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo

Primary Outcome Measure

Parts 1 and 2: Progression-Free Survival (PFS) - investigator assessment [ Time Frame: Up to 6 years ]

Locations (59)

FacilityCityStateZIPSite coordinators
GSK Investigational SitePhoenixArizona85016-
GSK Investigational SiteScottsdaleArizona85016-
GSK Investigational SiteTucsonArizona85704-
GSK Investigational SiteTucsonArizona85710-
GSK Investigational SiteNewport BeachCalifornia92663-
GSK Investigational SitePalo AltoCalifornia94304-
GSK Investigational SiteDeerfield BeachFlorida33442-
GSK Investigational SiteJacksonvilleFlorida32207-
GSK Investigational SiteMiamiFlorida33136-
GSK Investigational SiteMiamiFlorida33176-
GSK Investigational SiteOrlandoFlorida32804-
GSK Investigational SiteAtlantaGeorgia30342-
GSK Investigational SiteAugustaGeorgia30912-
GSK Investigational SiteSavannahGeorgia31405-
GSK Investigational SiteHinsdaleIllinois60521-
GSK Investigational SiteZionIllinois60099-
GSK Investigational SiteFort WayneIndiana46845-
GSK Investigational SiteIndianapolisIndiana46202-
GSK Investigational SiteIndianapolisIndiana46260-
GSK Investigational SiteIowa CityIowa52242-
GSK Investigational SiteLexingtonKentucky40536-
GSK Investigational SiteCovingtonLouisiana70433-
GSK Investigational SiteNew OrleansLouisiana70121-
GSK Investigational SiteShreveportLouisiana71103-
GSK Investigational SiteBostonMassachusetts02114-
GSK Investigational SiteSpringfieldMassachusetts01199-
GSK Investigational SiteDetroitMichigan48201-
GSK Investigational SiteSt LouisMissouri63108-
GSK Investigational SiteLebanonNew Hampshire03756-
GSK Investigational SiteAlbuquerqueNew Mexico87131-
GSK Investigational SiteRio RanchoNew Mexico87124-
GSK Investigational SiteAlbanyNew York12208-
GSK Investigational SiteMineolaNew York10016-
GSK Investigational SiteNew YorkNew York10016-
GSK Investigational SiteThe BronxNew York10461-
GSK Investigational SiteCharlotteNorth Carolina28204-
GSK Investigational SiteDurhamNorth Carolina27710-
GSK Investigational SiteKernersvilleNorth Carolina27284-
GSK Investigational SiteMount AiryNorth Carolina27030-
GSK Investigational SiteWinston-SalemNorth Carolina27103-
GSK Investigational SiteCincinnatiOhio45219-
GSK Investigational SiteCincinnatiOhio45220-
GSK Investigational SiteClevelandOhio44106-
GSK Investigational SiteColumbusOhio43210-
GSK Investigational SiteHilliardOhio43026-
GSK Investigational SiteHilliardOhio43210-
GSK Investigational SiteTulsaOklahoma74146-
GSK Investigational SitePhiladelphiaPennsylvania19111-
GSK Investigational SitePittsburghPennsylvania15224-
GSK Investigational SiteWillow GrovePennsylvania19090-
GSK Investigational SiteProvidenceRhode Island02905-
GSK Investigational SiteKnoxvilleTennessee37920-
GSK Investigational SiteAustinTexas78731-
GSK Investigational SiteAustinTexas78758-
GSK Investigational SiteDallasTexas75246-
GSK Investigational SiteDallasTexas76104-
GSK Investigational SiteCharlottesvilleVirginia22903-
GSK Investigational SiteRoanokeVirginia24016-
GSK Investigational SiteSeattleWashington98109-

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