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)

Official 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)

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).

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
• Overall Survival

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
• Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
• Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
• Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Investigator
• Progression-Free Survival 2 (PFS2) per Response Evaluation Criteria in Solid Tumours Version 1.1 (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 Adverse Event (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
• Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Combined Score
• Time to Deterioration (TTD) 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
• Time to Deterioration (TTD) in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Combined Score

View this trial on ClinicalTrials.gov