About this trial
The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS).
Each participant will participate in the study from the time that the participant provides documented informed consent through the final protocol-specified contact. After a screening phase of up to 28 days, each participant will be assigned to receive study intervention until one of the conditions for discontinuation of study intervention is met.
After the end of treatment, each participant will be followed for the occurrence of adverse events and spontaneously reported pregnancy.
Key Eligibility Criteria:
• Stage III or IV, persistent/recurrent, or metastatic EC
• Measurable/nonmeasurable disease (radiological apparent)
• No previous chemo for adjuvant or 1L except as part of radiosensitizing
• ECOG 0-1
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
Where’s this trial being run?
Bon Secours Cork and St James’s Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
Why not Print this page and bring it with you. It will help your doctor and research team advise you.Print this page
For more detailed informationClick Here
|Name:||ENGOT-en15/ KEYNOTE-C93-00/ GOG-3064|
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)
|Principal Investigator:||Prof. Karen Cadoo|
Global: FPFV achieved Feb 3rd, 2022
Ireland: 2nd September 2022
|Global Recruitment Target:||350|
|Ireland Recruitment Target:||6|