A PHASE III RANDOMIZED, PLACEBO-CONTROLLED STUDY OF PEMBROLIZUMAB (MK-3475, NSC #776864) IN ADDITION TO PACLITAXEL AND CARBOPLATIN FOR MEASURABLE STAGE III OR IVA, STAGE IVB OR RECURRENT ENDOMETRIAL CANCER
Principal Investigator
Ramez Eskander, MD
Status
Closed to Accrual
Date Opened To Accrual
July 01 2019
Date Closed to Accrual
December 06 2022
Disease Site
Gynecologic [GY]
Uterine Corpus
Phase
III
Developmental Therapeutics
No
Primary Objective
To evaluate the efficacy of pembrolizumab in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer. Efficacy will be determined via investigator assessed progression free survival (PFS) in two distinct populations referred to as proficient and deficient mismatch repair (pMMR and dMMR).
Protocol and Other Documents:
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website
Patient Population
Women with measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer who have undergone institutional MMR IHC testing.
Target Accrual
810
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.