Clinical Trial Details

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

Categories (click each to see list of all clinical trials associated with that category): Gynecology (GYN)

Current Status: Open to accrual

Phase: III

Principal Investigator: Rodabaugh, Kerry

Contact Information:
Pamela Nielsen
pnielsen@nebraskamed.com

Eligibility: https://clinicaltrials.gov/ct2/show/NCT03914612?cond=NCT03914612&draw=2&rank=1#eligibility

Summary
Primary Objective 1.1.1 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) as assessed by RECIST 1.1 in two distinct populations referred to as proficient and deficient mismatch repair (pMMR and dMMR). Secondary Objectives (07/03/2019) 1.2.1 To determine the nature, frequency and degree of toxicity as assessed by CTCAE for each treatment arm. 1.2.2 To evaluate BICR assessed or investigator assessed objective response rate (ORR) as assessed by RECIST 1.1 by treatment arm and by MMR status in patients who enter the study with measurable disease. 1.2.3 To evaluate BICR assessed or investigator assessed duration of response (DOR) by treatment arm and by MMR status in patients who enter the study with measurable disease. 1.2.4 To evaluate the effect of pembrolizumab on OS in patients with pMMR or dMMR. 1.2.5 To determine whether the addition of pembrolizumab to standard combination chemotherapy is associated with improved patient reported physical function as measured with the PROMIS-physical function scale (short form), quality of life as measured with the FACT-En TOI and worsened fatigue as measured with the PROMIS-Fatigue scale (short form) in the pMMR patients. 1.2.6 To determine concordance between institutional MMR IHC testing and centralized MMR IHC.