Panagiotis Konstantinopoulos, MD, PhD
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)
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…
Inclusion Criteria: * Participants must have endometrial cancer that is ARID1A-mutated \[loss of function (LOF) mutations\] determined by any CLIA-certified next-generation sequencing assay. ARID1A LOF mutation status must be confirmed by the principal investigator prior to participant enrollment. * Participants must have measurable disease per RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions). Each lesion must be \>= 10 mm when measured by CT, MRI or cal…
Human IgG1 antibody, 20mL single-use vials, via intravenous (into the vein) infusion per protocol.
Ataxia Telangiectasia and Rad3-related protein (ATR) inhibitor, 30 and 50 mg capsules, taken orally per protocol.
Arctuva estimate
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