Phase 2 Study of Avelumab and ATR Inhibitor M1774 for Women with ARID1A-Mutated Recurrent Endometrial Cancer After Prior Immunotherapy

What this Trial Is About

Researchers are evaluating the combination of two study drugs, avelumab and M1774, in participants with ARID1A-mutated recurrent endometrial cancer who have previously received immunotherapy. This is a phase 2, non-randomized, open-label trial aiming to study the safety and effectiveness of these drugs, which are not yet FDA-approved for this specific condition. The study is supported by EMD Serono and includes participants with measurable disease confirmed by specific genetic testing. Participants will receive avelumab as an intravenous infusion and M1774 as an oral capsule following a specific dosing schedule. The first six participants will undergo a lead-in phase with dose adjustments for M1774 based on tolerance. Treatment cycles last 42 days with M1774 taken daily during specified days and avelumab administered on days 1, 15, and 29. Participants will be treated for up to two years and will undergo regular imaging scans every 12 weeks to monitor disease status. During the study, participants will attend visits for screening, treatment, and follow-up including CT or MRI scans, blood and urine tests, and ECGs. There will be visits after treatment ends at 30 and 90 days, followed by long-term follow-up every six months for up to three years. Researchers will measure outcomes such as progression-free survival at six months and objective response rate over two years, along with safety evaluations. The total participation may last several years to monitor long-term effects and outcomes.

Avelumab and M1774 in ARID1A-mutated Endometrial Cancer