ENGOT-en15/ KEYNOTE-C93-00/ GOG-3064

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.

Patient Profile

Key Eligibility Criteria:
• Stage III or IV, persistent/recurrent, or metastatic EC
• Measurable/nonmeasurable disease (radiological apparent)
• dMMR
• 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.

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For more detailed information

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Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	ENGOT-en15/ KEYNOTE-C93-00/ GOG-3064
Number:	22-02
Full Title:	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
Type:	Industry Sponsored
Sponsor:	MSD
Recruitment Started:	Global: FPFV achieved Feb 3rd, 2022 Ireland: 2nd September 2022

Global Recruitment Target:	350
Ireland Recruitment Target:	6