Actively Recruiting
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
Led by Panagiotis Konstantinopoulos, MD, PhD · Updated on 2026-01-07
25
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
P
Panagiotis Konstantinopoulos, MD, PhD
Lead Sponsor
E
EMD Serono
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Avelumab and M1774 in ARID1A-mutated Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Diagnosis of endometrial cancer with ARID1A loss of function mutation confirmed by a certified genetic test
- Measurable disease by imaging or clinical exam as defined by RECIST 1.1 criteria
- Prior treatment with at least one chemotherapy regimen for endometrial cancer
- Prior immunotherapy targeting PD-1 or PD-L1 pathway, with up to 50% allowed without this prior immunotherapy
- ECOG performance status 0, 1, or 2
- Availability of cancer tissue samples for study
- Adequate organ and marrow function based on lab tests
- Negative pregnancy test for women of child-bearing potential and agreement to use contraception
- Ability and willingness to provide informed consent
You will not qualify if you...
- Recent chemotherapy, immunotherapy, investigational therapy, or radiotherapy within 4 weeks prior to study start (6 weeks for certain drugs)
- Unresolved adverse events from prior cancer treatments above Grade 1 unless stable or not safety risk
- Use of any other investigational agents
- Presence of meningeal carcinomatosis or uncontrolled brain metastases
- Known severe allergies to study drugs or related antibodies
- Active or uncontrolled infections, except well-controlled HIV, HBV, or treated HCV infections
- Use of immunosuppressive medications within 7 days prior to enrollment except certain steroids
- Active autoimmune diseases likely to worsen with immunotherapy
- History of organ transplantation
- Severe gastrointestinal conditions or uncontrolled diarrhea
- Psychiatric or social conditions making participation inappropriate
- Uncontrolled cardiovascular conditions
- Known alcohol or drug abuse
- Recent other malignancies unless disease-free for 5 years or low risk of recurrence
- Severe medical conditions or lab abnormalities increasing study risk
- Vaccination with live vaccines within 4 weeks before treatment
- Use of herbal or prohibited medications affecting drug metabolism
- Pregnancy or breastfeeding
- Prolonged QTc interval not corrected by electrolytes correction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments including genetic testing and baseline scans.
Duration - Up to 2 years
Participants receive avelumab intravenously and oral M1774 capsules in repeated 42-day cycles for up to 2 years.
Visits on Days 1, 15, and 29 of each 42-day cycle for avelumab infusions and daily M1774 dosing on specified days; CT or MRI scans every 12 weeks.
Duration - Up to 3 years
After treatment ends, participants attend follow-up visits to monitor health and disease status for up to 3 years.
One visit at 30 days post-treatment, one visit at 90 days post-treatment, then visits every 6 months.
Trial Site Locations
Total: 2 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
P
Panagiotis Konstantinopoulos, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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