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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: 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

Study ID: NCT02912572

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Chicago, Chicago, Illinois, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Contact Details

Name: Panagiotis Konstantinopoulos, MD, PhD

Affiliation: Dana-Farber Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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