Trials / Active Not Recruiting
Active Not RecruitingNCT05173987
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)
A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pembrolizumab | Intravenous (IV) infusion |
| DRUG | carboplatin | IV infusion |
| DRUG | paclitaxel | IV infusion |
| DRUG | docetaxel | IV infusion |
| DRUG | cisplatin | IV infusion |
Timeline
- Start date
- 2022-02-03
- Primary completion
- 2027-05-27
- Completion
- 2027-05-27
- First posted
- 2021-12-30
- Last updated
- 2024-11-21
Locations
195 sites across 27 countries: United States, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, Germany, Hungary, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05173987. Inclusion in this directory is not an endorsement.