Dostarlimab
BiologicalParticipants will be administered dostarlimab
Other names: TSR-042
NCT Number: NCT03981796
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Interventional
Phase 3
GSK Investigational Site, Grodno, Belarus
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Part 1 and Part 2:
Part 2 only:
Exclusion criteria
Part 1 and Part 2:
Part 2 only:
Participants will be administered dostarlimab
Other names: TSR-042
Participants will be administered placebo matching dostarlimab
Participants will be administered carboplatin
Participants will be administered paclitaxel
Participants will be administered niraparib
Participants will be administered placebo matching Niraparib
Time frame: Up to 6 years
Time frame: Up to 6 years
Time frame: Up to 6 years
Time frame: Up to 6 years
Time frame: Up to 6 years
Time frame: Up to 6 years
Time frame: Up to 6 years
Time frame: Up to 6 years
EQ-5D-5L is a validated questionnaire to assess the overall health-related quality of life in participants across diseases.
Time frame: Up to 6 years
EORTC QLQ-C30 is validated questionnaire to assess overall health-related quality of life in participants with cancer.
Time frame: Up to 6 years
EORTC QLQ-EN24 is a validated questionnaire to assess the overall health-related quality of life in participants with all stages of endometrial cancer.
Time frame: Up to 6 years
Time frame: Up to 6 years
Time frame: Up to 6 years
Time frame: Baseline and up to 6 Years
Time frame: Baseline and up to 6 Years
Time frame: Baseline and up to 6 Years
Time frame: Baseline and up to 6 Years
Time frame: Up to 6 years
Performance status will be assessed using the ECOG scale, with status score ranging from 0 to 5.
Time frame: Predose (Day 1) and postdose (Day 1) of Cycles 1, 2, 6, 7, 10, 15, and 20 (Cycle 1, 2, 6 is 21 days and Cycle 7, 10, 15, 20 is 42 days)
Time frame: Predose (Day 1) and postdose (Day 1) of Cycles 1, 2, 6, 7, 10, 15, and 20 (Cycle 1, 2, 6 is 21 days and Cycle 7, 10, 15, 20 is 42 days)
Time frame: Predose (Day 1) and 3 hours postdose (Day 1) of Cycles 7 and 8 and Predose (Day 1) of Cycles 10 and 14 (each cycle is 42 days)
Time frame: Predose (Day 1) and 3 hours postdose (Day 1) of Cycles 7 and 8 and Predose (Day 1) of Cycles 10 and 14 (each cycle is 42 days)
Time frame: Predose (Day 1)
Tesaro, Inc.
Industry
A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer (RUBY)
Acronym: RUBY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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