Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer

Phase 2 Active not recruiting 106 enrolled Dana-Farber Cancer Institute Pfizer · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This research study is evaluating a drug called Avelumab alone and in combination with Talazoparib or Axitinib as a possible treatment for recurrent or metastatic endometrial cancer.

Timeline

Start: 2016-11-14
Primary completion: 2023-11-15
Completion: 2026-11

Outcome

Met primary endpoint

paper 9 (25.7%) derived clinical benefit after meeting at least 1 of the 2 coprimary end points. PMID 35900726 ↗

paper The results of this nonrandomized controlled trial suggest that treatment with avelumab and talazoparib demonstrated a favorable toxic effect profile and met the predetermined criteria to be considered worthy of further evaluation in MMRP EC. PMID 35900726 ↗

Publications

Konstantinopoulos PA, Gockley AA, Xiong N, Krasner C, Horowitz N, Campos S, Wright AA, Liu JF, Shea M, Yeku O, Castro C, Polak M, Lee EK, Sawyer H, Bowes B, Moroney J, Cheng SC, Tayob N, Bouberhan S, Spriggs D, Penson RT, Fleming GF, Nucci MR, Matulonis UA. Evaluation of Treatment With Talazoparib and Avelumab in Patients With Recurrent Mismatch Repair Proficient Endometrial Cancer. JAMA Oncol. 2022 Sep 1;8(9):1317-1322. doi: 10.1001/jamaoncol.2022.2181.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avelumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Axitinib	Small molecule	—	Oral
Subject	Talazoparib	Small molecule	1 mg	Oral