Treating Recurrent or Metastatic Endometrial Cancer with an Immunotherapy in Combination with a PARP Inhibitor or a Chemotherapy Drug

About the Study

This study will determine the effectiveness of an immunotherapy called Avelumab, in treating recurrent or metastatic endometrial cancer. Participants will receive Avelumab, either alone or in combination with other drugs. The effectiveness of the study drugs will be measured through tumor biopsies. NOTE: This study is no longer enrolling patients.

What the Study Involves

There will be four treatment groups in this study and participants will be selected based on their tumor type.

Group 1: MSI-H and/or a POLE mutation 
This group will be open to people with one of two tumor types: MSI-H (microsatellite instability-High) and/or a POLE-mutation. MSI-H and POLE mutations are tumor markers found in some endometrial cancers. MSI-H cancers are common in people with Lynch syndrome

• This group will receive Avelumab intravenously for a total of two times per 28-day cycle. 

Group 2: MSS
This group will be open to people with a type of tumor that is MSS (microsatellite stable). 

• This group will receive Avelumab intravenously for a total of two times per 28-day cycle. 

Group 3: MSS

• This group will receive Avelumab intravenously for a total of two times per 28-day cycle.
• This group will also take Talazoparib orally once per day for the 28-day cycle. 

Group 4: MSS

This group will be open to people with a type of tumor that is MSS (microsatellite stable). 

• This group will receive Avelumab intravenously for a total of 2 times per 28-day cycle.
• This group will also take Axitinib orally twice a day for the 28-day cycle. 

All groups will receive the following: 

• Premedication antihistamines (allergy medicine) and acetaminophen (such as Tylenol) will be administered prior to starting the treatment.
• Cycles will continue for up to 2 years.

Study Locations

Illinois

• Chicago
  University of Chicago
  Contact: Gini Fleming, MD 773-702-6721

Massachusetts

• Boston
  Massachusetts General Hospital
  Contact: Richard Penson, MD 617-742-4800
• Boston
  Beth Israel Deaconess Medical Center
  Contact: Page Widick, MD 617-667-2100
• Boston
  Dana Farber Institute
  Contact: Panagiotis A Konstantinopoulos, MD 617-632-5269or  by email 

People with advanced or recurrent endometrial cancer who are 18 years and older and have:

• Group 1 have one or both of the following tumor markers:
  • MSI-H (microsatellite instability-high)
  • POLE mutation 
• Groups 2, 3, and 4 have the following tumor marker:
  • MSS (microsatellite stable)
• received at least one prior chemotherapy treatment for their endometrial cancer.
• prior hormonal therapy is allowed
• available tumor tissue or have tumors that can be biopsied

People with the following are not eligible to participate:

• have received chemotherapy or radiation within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from side effects from prior treatment
• participating in any other clinical trial involving drugs 
• cancer that has spread to the brain 
• history of treatment with an immunotherapy drug
• active infection with HIV, AIDS, Hepatitis B, or Hepatitis C
• severe stomach conditions
• uncontrolled illness including congestive heart failure, unstable chest pain, irregular heartbeat or psychiatric illness/social situations that would limit the ability to follow the study requirements
• pregnant or breastfeeding
• participants in Arms 3:
  • must NOT have received a PARP inhibitor prior to the study
• participants in Arm 4:
  • must NOT have received axitinib prior to the study