Study on Avelumab and M1774 for Treating Endometrial Cancer with ARID1A Mutation

Sponsor: Panagiotis Konstantinopoulos, MD, PhD

Sponsor score: 0

ClinicalTrials ID:NCT06518564

Provider View

This clinical trial is testing a combination of two drugs, avelumab and M1774, to see if they are safe and effective for patients with endometrial cancer that has a specific genetic mutation. The study involves various medical tests and treatments over a period of up to 3 years.

Patient Parameters

Program Overview

The purpose of this study is to find out if the combination of two drugs, avelumab and M1774, is safe and effective for treating endometrial cancer with a specific genetic mutation called ARID1A. Avelumab is a type of antibody, and M1774 is an ATR inhibitor. The study will involve about 25 participants who will receive these drugs for up to 2 years and be monitored for up to 3 years. Participants will undergo various medical tests, including blood and urine tests, scans, and heart monitoring, to ensure the treatment is safe and effective. EMD Serono is providing the study drugs for this research.

Description

This study is a phase 2 trial that is not randomized, meaning all participants will receive the same treatment. It is open-label, so both the researchers and participants know what treatment is being given. The trial is for patients with endometrial cancer that has a specific mutation (ARID1A) and who have already received some form of immunotherapy. The U.S. FDA has approved avelumab for other uses but not specifically for this type of cancer, and M1774 is not yet approved for any disease. Participants will be screened for eligibility and will undergo various tests and treatments, including blood and urine tests, CT or MRI scans, and ECGs. The study will last up to 3 years, with treatment given for up to 2 years. Participants will be closely monitored throughout the study to ensure their safety and to evaluate the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have endometrial cancer with a specific ARID1A mutation, confirmed by a certified lab test.
  • Must have measurable cancer that can be tracked by scans or exams.
  • Must have had at least one previous chemotherapy treatment for endometrial cancer.
  • Must have received prior immunotherapy targeting the PD-1/PD-L1 pathway.
  • Must be 18 years or older.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must provide a sample of cancer tissue from a previous surgery or biopsy.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a specified period after treatment.
  • Must be able to understand and sign a written informed consent document.

Exclusion Criteria

  • Recent chemotherapy or radiotherapy within 4 weeks before starting the study.
  • Unresolved side effects from previous cancer treatments, unless they are stable and not a safety risk.
  • Currently taking other investigational drugs.
  • Uncontrolled brain metastases or meningeal carcinomatosis.
  • Severe allergies to avelumab, M1774, or similar drugs.
  • Active or uncontrolled infections, unless well-managed and not expected to interact with study drugs.
  • Use of immunosuppressive medication within 7 days before starting the study, with some exceptions.
  • Active autoimmune diseases that could worsen with treatment.
  • History of organ transplantation.
  • Severe gastrointestinal conditions or uncontrolled diarrhea.
  • Psychiatric conditions that could interfere with study participation.
  • Uncontrolled high blood pressure or serious heart conditions.
  • History of alcohol or drug abuse.
  • Recent history of other cancers, unless disease-free for at least 5 years or considered low risk.
  • Severe medical conditions that could increase risk or interfere with the study.
  • Recent vaccination with live vaccines.
  • Use of certain herbal products or medications that could interact with study drugs.
  • Pregnant or breastfeeding women, due to potential risks to the baby.
  • Abnormal heart rhythm that does not improve with treatment.

Locations

FACILITYZIPCITYSTATE
Dana-Farber Cancer Institute02115BostonMassachusetts
Brigham and Women's Hospital02215BostonMassachusetts

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