Actively Recruiting
Avelumab and M1774 in ARID1A-mutated Endometrial Cancer
Led by Panagiotis Konstantinopoulos, MD, PhD · Updated on 2026-01-07
25
Participants Needed
2
Research Sites
250 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
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)
CONDITIONS
Official 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 certified testing
- Presence of measurable disease according to RECIST 1.1 criteria
- Must have received at least one prior chemotherapy regimen for endometrial carcinoma
- Prior immunotherapy targeting PD-1/PD-L1 pathway received, with up to 50% allowed without this prior treatment
- ECOG performance status of 0, 1, or 2
- Availability of tumor tissue sample for testing
- Adequate organ and marrow function as defined by specific blood counts and liver and kidney function
- Negative pregnancy test for women of child-bearing potential and agreement to use contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Chemotherapy, immunotherapy, investigational therapy, or radiotherapy within 4 weeks prior to study entry (6 weeks for specific drugs)
- Unresolved adverse events from prior cancer therapy above grade 1 unless stable and not a safety risk
- Current use of other investigational agents
- Presence of meningeal carcinomatosis or uncontrolled brain metastases
- Known severe hypersensitivity to avelumab, M1774, or related monoclonal antibodies
- Active or uncontrolled infections except controlled HIV, HBV, or treated HCV infections
- Use of immunosuppressive medication within 7 days prior to enrollment with specific exceptions
- Active autoimmune diseases that may worsen with immunotherapy, except certain controlled conditions
- History of organ transplantation
- Severe gastrointestinal conditions such as recent bowel obstruction or uncontrolled diarrhea
- Psychiatric or social conditions that may interfere with study participation
- Uncontrolled cardiovascular conditions within 180 days prior to treatment
- Known alcohol or drug abuse
- History of other malignancies unless disease-free for 5 years or low risk of recurrence
- Severe acute or chronic medical conditions increasing study risk
- Vaccination with live vaccines within 4 weeks of treatment initiation
- Use of herbal or prohibited medications that may interact with study drugs
- Pregnant or breastfeeding women
- QTc interval over 470 msec not correctable with electrolyte management
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here