KEYNOTE-B21 / ENGOT-en11 / GOG-3053
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)
IRAS ID
1003547
Contact name
Robert Orlowski
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2020-003424-17
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3, randomised, double-blind, parallel group, multi-centre study to compare efficacy and safety of pembrolizumab vs placebo in combination with standard of care (SoC) chemotherapy with or without radiotherapy in participants with newly diagnosed high-risk endometrial cancer who have undergone curative intent surgery.
Endometrial cancer is the sixth most common cancer and most frequent gynecological tumour in women worldwide with approximately 380,000 new cases diagnosed and 90,000 deaths resulting in 2018. The study has been designed based on promising data from investigator-initiated studies and the high unmet need in patients with high risk endometrial cancer.
Approximately 990 female participants, at least 18 years of age, will be randomised in a 1:1 ratio between 2 treatment arms:
- Arm 1: Pembrolizumab every 3 weeks for 6 cycles in combination with chemotherapy (Stage 1) followed by pembrolizumab alone every 6 weeks for 6 cycles (Stage 2); or
- Arm 2: Placebo every 3 weeks for 6 cycles in combination with chemotherapy (Stage 1) followed by placebo alone every 6 weeks for 6 cycles (Stage 2).Radiotherapy is optional at the investigator’s discretion within Stage 1 and Stage 2 but must be determined before randomisation.
The study will require approximately 4.5 years from the time the first participant (or their legally acceptable representative) provides documented informed consent until the last participant’s last study-related contact.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0164
Date of REC Opinion
28 May 2021
REC opinion
Favourable Opinion