NCT02912572

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

A Phase 2, Two-Group, Two-Stage, Open-Label Study of Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer, Avelumab / Talazoparib in Patients With MSS Recurrent or Persistent Endometrial Cancer, and Avelumab / Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved the drug for use in patients, including people with Metastatic Endometrial Cancer. Avelumab is a drug that may stop cancer cells from growing by enabling the activation of the immune system. Avelumab blocks an immune inhibiting signal that can impair the ability of the immune system to attack cancers. Talazoparib is a drug that stops the activity of a protein (called PARP) that's involved in repairing damage to the DNA within your cells. When PARP is turned off by Talazoparib in cancer cells, DNA damage cannot be repaired and leads to the death of the cancer cells. Axitinib is a drug that may stop cancer cells from growing by blocking certain proteins that cancer cells use to form new blood vessels, which the cancer needs in order to grow. In this research study, the investigators are looking to see whether Avelumab, the combination of Avelumab and Talazoparib, or the combination of Avelumab and Axitinib are effective in treating recurrent and Metastatic Endometrial Cancer. Additionally, the investigators are looking to see if participants whose tumors contain a particular genetic make-up will have better response to Avelumab, the combination of Avelumab and Talazoparib, or the combination of Avelumab and Axitinib.

Conditions

• Metastatic Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Avelumab	Avelumab will be administered intravenously twice per cycle Each Cycle lasts 28 days Premedication Antihistamine and Paracetamol will be administered prior to treatment
DRUG	Talazoparib	Talazoparib will be taken one time per day by mouth Each Cycle lasts 28 days
DRUG	Axitinib	Axitinib will be taken twice per day by mouth Each Cycle lasts 28 days

Timeline

• Start date: 2016-11-14
• Primary completion: 2023-11-15
• Completion: 2026-11-01
• First posted: 2016-09-23
• Last updated: 2025-07-10
• Results posted: 2024-07-05

Locations

4 sites across 1 country: United States