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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506361-56-00

Acronym

MK-3475-C93

Enrollment

153

Registered

2023-12-13

Start date

2022-04-01

Completion date

Unknown

Last updated

2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial cancer

Brief summary

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), Overall survival (OS)

Detailed description

Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR, Disease Control Rate (DCR) per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, PFS per RECIST 1.1 as Assessed by Investigator, Progression-Free Survival 2 (PFS2) per RECIST 1.1 as Assessed by Investigator, Number of Participants Who Experience at Least One Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) (Item 29) And Quality of Life (QoL) (Item 30) Combined Score

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPACLITAXEL

DRUGDOCETAXEL

DRUGCISPLATIN

DRUGCARBOPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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), Overall survival (OS)	—

Secondary

Measure	Time frame
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR, Disease Control Rate (DCR) per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, PFS per RECIST 1.1 as Assessed by Investigator, Progression-Free Survival 2 (PFS2) per RECIST 1.1 as Assessed by Investigator, Number of Participants Who Experience at Least One Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) (Item 29) And Quality of Life (QoL) (Item 30) Combined Score	—

Measure

Time frame

—

Countries

Belgium, Czechia, Denmark, Finland, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026