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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
785
Participants will be administered dostarlimab
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
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Newport Beach, California, United States
Parts 1 and 2: Progression-Free Survival (PFS) - investigator assessment
Time frame: Up to 6 years
Part 1: Overall survival
Time frame: Up to 6 years
Part 2: Overall survival
Time frame: Up to 6 years
Parts 1 and 2: Progression free survival (PFS) blinded independent central review (BICR)
Time frame: Up to 6 years
Parts 1 and 2: Objective response rate (ORR) - BICR and Investigator assessment
Time frame: Up to 6 years
Parts 1 and 2: Duration of response (DOR) - BICR and Investigator assessment
Time frame: Up to 6 years
Parts 1 and 2: Disease control rate (DCR) - BICR and Investigator assessment
Time frame: Up to 6 years
Parts 1 and 2: Patient-reported outcomes (PROs) in the European Quality of Life scale, 5-Dimensions, 5-Levels (EQ-5D-5L)
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
Parts 1 and 2: PROs in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30 [Core])
EORTC QLQ-C30 is validated questionnaire to assess overall health-related quality of life in participants with cancer.
Time frame: Up to 6 years
Parts 1 and 2: PROs in the EORTC Quality of Life Questionnaire (Endometrial Cancer Module [QLQ-EN24])
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
Parts 1 and 2: Progression-free survival 2 (PFS2)
Time frame: Up to 6 years
Parts 1 and 2: Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Time frame: Up to 6 years
Parts 1 and 2: Number of participants with clinically significant changes in clinical laboratory parameters, physical examination, electrocardiogram (ECG) and participants reporting the intake of concomitant medication
Time frame: Up to 6 years
Parts 1 and 2: Change from Baseline in vital sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury)
Time frame: Baseline and up to 6 Years
Parts 1 and 2: Change from Baseline in vital sign: Heart Rate
Time frame: Baseline and up to 6 Years
Parts 1 and 2: Change from Baseline in vital sign: Respiratory rate
Time frame: Baseline and up to 6 Years
Parts 1 and 2: Change from Baseline in vital sign: Body temperature
Time frame: Baseline and up to 6 Years
Parts 1 and 2: Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
Performance status will be assessed using the ECOG scale, with status score ranging from 0 to 5.
Time frame: Up to 6 years
Parts 1 and 2: Minimum observed concentration (Cmin) and maximum observed concentration (Cmax) of dostarlimab (micrograms per milliliter)
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)
Parts 1 and 2: Cmin and Cmax at steady state of dostarlimab (micrograms per milliliter)
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)
Part 2: Cmin and Cmax of niraparib (nanograms per milliliter)
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)
Part 2: Cmin and Cmax at steady state of niraparib (nanograms per milliliter)
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)
Parts 1 and 2: Number of participants with anti-drug antibodies (ADA) against dostarlimab
Time frame: Predose (Day 1)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Palo Alto, California, United States
GSK Investigational Site
Deerfield Beach, Florida, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
...and 159 more locations