NCT06518564

Avelumab and M1774 in ARID1A-mutated Endometrial Cancer

A Phase 2 Study of Avelumab in Combination With ATR Inhibitor M1774 in Patients With ARID1A-mutated Recurrent Endometrial Cancer Who Have Received Prior Immunotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Panagiotis Konstantinopoulos, MD, PhD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to see if the combination of study drugs avelumab and M1774 is effective and safe for participants with endometrial cancer. The names of the study drugs involved in this study are: * Avelumab (a type of human IgG1 antibody) * M1774 (a type of ATR inhibitor)

Detailed description

This is a non-randomized, open-label, two-stage, phase 2 trial of avelumab in combination with ATR inhibitor (ATRi) M1774 in participants with ARID1A-mutated endometrial cancers who have received prior immunotherapy. The U.S. Food and Drug Administration (FDA) has not approved avelumab for ARID1A-mutated recurrent endometrial cancer but it has been approved for other uses. The FDA has not approved M1774 as a treatment for any disease. The research study procedures including screening for eligibility, in-clinic treatment visits, blood tests, urine tests, Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans, and electrocardiograms (ECGs). Participants will receive study treatment for up to 2 years and will be followed for up to 3 years until the study is complete. It is expected that about 25 people will take part in this research study. EMD Serono is supporting this research study by providing the study drugs avelumab and M1774.

Conditions

• Endometrial Cancer
• ARID1A Gene Mutation
• Recurrent Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	Avelumab	Human IgG1 antibody, 20mL single-use vials, via intravenous (into the vein) infusion per protocol.
DRUG	M1774	Ataxia Telangiectasia and Rad3-related protein (ATR) inhibitor, 30 and 50 mg capsules, taken orally per protocol.

Timeline

• Start date: 2024-11-14
• Primary completion: 2027-08-31
• Completion: 2029-08-31
• First posted: 2024-07-24
• Last updated: 2026-01-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study