NRG-GY018
Closed to Accrual & Treatment
Protocol Information
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 N. Eskander
Status
Closed to Accrual & Treatment
Open to Accrual
July 16, 2019
Temporarily Closed to Accrual
July 16, 2019
Open to Accrual
July 29, 2019
Temporarily Closed to Accrual
April 6, 2020
Open to Accrual
November 30, 2020
Closed to Accrual
December 6, 2022
Closed to Accrual & Treatment
November 1, 2024
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
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
Patient Study Webpage
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