Trial Details 87 Total Sites

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

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. Part 1 has completed enrollment, and Part 2 is open for enrollment. Both Parts consist of a Screening Period, Treatment Period, an End of Treatment (EOT) Visit, a Safety Follow-up Visit, and a Survival Assessment Period. In Part 2, participants will be randomized 1:2 to receive either carboplatin/paclitaxel/placebo or Dostarlimab/carboplatin/paclitaxel followed by Dostarlimab/niraparib or placebo iv/oral maintenance.

phase

Phase 3

status

Recruiting

enrollment

740

score

49

start date

2019-07-18

last updated

2021-11-04

biomarkers

N/A

New York City, New York
facility
GSK Investigational Site
1 facility
Recruiting
Philadelphia, Pennsylvania
facility
GSK Investigational Site
1 facility
Recruiting
Phoenix, Arizona
facility
GSK Investigational Site
1 facility
Recruiting
Dallas, Texas
facility
GSK Investigational Site
1 facility
Recruiting
Austin, Texas
facility
GSK Investigational Site
1 facility
Recruiting
Jacksonville, Florida
facility
GSK Investigational Site
1 facility
Recruiting
Columbus, Ohio
facility
GSK Investigational Site
1 facility
Recruiting
Fort Worth, Texas
facility
GSK Investigational Site
1 facility
Recruiting
Indianapolis, Indiana
facility
GSK Investigational Site
facility
GSK Investigational Site
2 facilities
Recruiting
Charlotte, North Carolina
facility
GSK Investigational Site
1 facility
Recruiting
Seattle, Washington
facility
GSK Investigational Site
1 facility
Recruiting
Detroit, Michigan
facility
GSK Investigational Site
1 facility
Recruiting