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

NCT03981796 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 785

Last updated 2025-09-03

No results posted yet for this study

Summary

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.

Conditions

  • Neoplasms

Interventions

BIOLOGICAL

Dostarlimab

Participants will be administered dostarlimab

DRUG

Placebo matching dostarlimab

Participants will be administered placebo matching dostarlimab

DRUG

Carboplatin

Participants will be administered carboplatin

DRUG

Paclitaxel

Participants will be administered paclitaxel

DRUG

Niraparib

Participants will be administered niraparib

DRUG

Placebo matching Niraparib

Participants will be administered placebo matching Niraparib

Sponsors & Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • GOG Foundation

    collaborator NETWORK

  • Tesaro, Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2026-11-26
Completion
2026-11-26
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03981796 on ClinicalTrials.gov