A Randomized Phase III Trial of Carboplatin, Paclitaxel, Pembrolizumab Versus Carboplatin, Paclitaxel, Bevacizumab Versus Carboplatin, Paclitaxel, Pembrolizumab, Bevacizumab in the Treatment of pMMR, TP53 Mutated Advanced or Recurrent Endometrial Cancer
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: III
Principal Investigator: McAlarnen, Lindsey
Contact Information:
Evelyn Cantril, CRA
402-559-7507
ecantril@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07198074?term=NCT07198074&rank=1&tab=study#participation-criteria
Summary
Primary Objective
-To demonstrate that bevacizumab, an anti-VEGF antibody therapy, (or an anti-VEGF antibody biosimilar) in combination with carboplatin, paclitaxel, and pembrolizumab is superior to carboplatin, paclitaxel, and pembrolizumab (the control arm) or carboplatin, paclitaxel, and bevacizumab in prolonging PFS in patients with pMMR, TP53 mutated advanced stage (III or IV) or recurrent endometrial cancer.
Secondary Objectives
-To demonstrate that bevacizumab in combination with carboplatin, paclitaxel, and pembrolizumab is superior to carboplatin, paclitaxel, and pembrolizumab or carboplatin, paclitaxel, and bevacizumab in prolonging OS in patients with pMMR, TP53 mutated advanced stage (III or IV) or recurrent endometrial cancer.
-To examine the impact of the addition of bevacizumab in combination with carboplatin and paclitaxel or with carboplatin, paclitaxel, and pembrolizumab on PFS and OS based on type of p53 IHC aberrancy (over expression/cytoplasmic expression versus null [complete absence of staining]) and mutation type.
-To evaluate toxicity on treatment with bevacizumab when combined with carboplatin, paclitaxel, and/or pembrolizumab as assessed by CTCAE v.5.0.
-To explore the anti-tumor activity in each treatment arm as assessed by objective response rate in the subset of patients with measurable disease by RECIST 1.1.