Treating Recurrent or Metastatic Endometrial Cancer with an Immunotherapy in Combination with a PARP Inhibitor or a Chemotherapy Drug
Clinicaltrials.gov identifier:
NCT02912572
Treatment study for metastatic endometrial cancer
Study Contact Information:
DFCI Clinical Trials Hotline: 887-338-7425
Principal Investigator: Panagiotis A Konstantinopoulos, MD
by phone: 617-632-5269 or by email
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 called Avelumab, in treating recurrent or 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
- 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 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 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 prior to the study
- participants in Arm 4:
- must NOT have received axitinib prior to the study