OncoMatch/Clinical Trials/NCT06518564
Avelumab and M1774 in ARID1A-mutated Endometrial Cancer
Is NCT06518564 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Avelumab and M1774 for endometrial cancer.
Treatment: Avelumab · M1774 — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: ARID1A loss of function mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — for management of endometrial carcinoma
patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma
Cannot have received: chemotherapy, immunotherapy, other investigational therapy, or radiotherapy (nitrosoureas, mitomycin C)
Exception: hormonal therapy (no washout required)
Participants who have had chemotherapy, immunotherapy, other investigational therapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. There is no required washout period for hormonal therapy.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Hemoglobin ≥ 9.0 g/dL (no erythropoietin or RBC transfusion within last 14 days); Platelets ≥ 100,000/mcL
Kidney function
Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault or institutional standard) OR GFR ≥ 60 mL/min (24-hour urine collection)
Liver function
Total bilirubin ≤ 1.5 institutional ULN (≤3 x ULN if Gilbert's syndrome); AST(SGOT)/ALT(SGPT) ≤ 2.5 × ULN (≤5 x ULN if hepatic involvement)
Cardiac function
QTc average (Fridericia) ≤ 470 msec (must resolve with correction of electrolyte abnormalities)
Participants must meet the following organ and marrow function as defined below: Absolute neutrophil count ≥ 1,500/mcL; Hemoglobin ≥ 9.0 g/dL (with no erythropoietin or red blood cell transfusion within the last 14 days); Platelets ≥ 100,000/mcL; Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) in the case of documented Gilbert's syndrome, total bilirubin ≤3 x ULN is allowed; AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN in patients with documented hepatic involvement, AST/ALT ≤ 5 x ULN is allowed; Creatinine clearance ≥ 60 mL/min as estimated by the Cockcroft-Gault formula or institutional standard method OR Glomerular filtration rate (GFR) ≥ 60 mL/min by measured 24-hour urine collection; Calculated QTc average (using the Fridericia correction calculation) of > 470 msec that does not resolve with correction of electrolyte abnormalities [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Brigham and Women's Hospital · Boston, Massachusetts
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