NRG-GY035

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

Principal Investigator

Amanda N. Fader

Status

Disease Site

Gynecologic [GY] Uterine Corpus

Phase

III

Developmental Therapeutics

Yes

Primary Objective

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.

Patient Population

Patients with stage III and stage IVA RECIST-evaluable disease; Stage IVB (with or without measurable disease), or recurrent (with or without measurable disease) endometrial cancer. Patients must have tumoral mismatch repair proficient (pMMR) disease as assessed by immunohistochemistry (IHC) AND P53 IHC with aberrant staining pattern (aberrant p53 expression is consistent with mutant TP53). TP53 mutation by next-generation sequencing will also be accepted.

Target Accrual

255