Avelumab and M1774 in ARID1A-mutated Endometrial Cancer (Prior IO)
NCT Number: NCT06518564
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Endometrial Cancer|ARID1A Gene Mutation|Recurrent Endometrial Carcinoma
Interventions: DRUG: Avelumab|DRUG: M1774
Sponsor: Panagiotis Konstantinopoulos, MD, PhD
Collaborators: EMD Serono|The Applebaum Foundation
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2029-08-31
Locations: Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States

Summary:
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)

Primary Outcome Measures: Progression Free Survival at 6 months (PFS6), PFS6 is the percent probability estimate at 6 months based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated., The observation period related to this endpoint is up to 6 months.|Objective Response Rate (ORR), ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions., The observation period related to this endpoint is up to 2 years.
Secondary Outcome Measures: Median Progression Free Survival (PFS), PFS based on Kaplan-Meier methodology was defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated., The observation period related to this endpoint is up to 2 years.|Median Overall Survival (OS), Overall survival based on the Kaplan-Meier method is defined as the time from registration to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant., The observation period related to this endpoint is up to 5 years.|Immune-Related Overall Response Rate(irORR), irORR was defined as the percentage of participants achieving immune-related complete response (irCR) or immune-related partial response (irPR) on treatment based on irRECIST criteria., The observation period related to this endpoint is up to 2 years.|Median Immune-related Progression-free Survival (irPFS), Immune-related progression-free survival (irPFS) rate is defined as time from treatment assignment to death or to immune-related progression of disease (irPD). Per ir RECIST, irPD was defined as Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases \>= 20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented, at the investigator's discretion., The observation period related to this endpoint is up to 2 years.|Grade 3-5 Treatment-Related Toxicity Rate, The percentage of participants who experienced a maximum grade 3-5 treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv4) as reported on case report forms., The observation period related to this endpoint is up to 2 years.