Avelumab and M1774 in ARID1A-mutated Endometrial Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Panagiotis Konstantinopoulos, MD, PhD
Study ID
NCT06518564
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Avelumab — DRUG
    Human IgG1 antibody, 20mL single-use vials, via intravenous (into the vein) infusion per protocol.
  • M1774 — DRUG
    Ataxia Telangiectasia and Rad3-related protein (ATR) inhibitor, 30 and 50 mg capsules, taken orally per protocol.

Study Details

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)

Key Dates

Start date
Nov 14, 2024
Status verified
Jan 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Avelumab and M1774
    25 participants will be enrolled and complete study procedures. The first 6 participants enrolled will take part in a lead-in phase with a dose de-escalation plan for M1744, starting at Dose Level 0 and decreasing to Dose Level -1 and then -2 if applicable per the protocol depending on the occurrence of dose-limiting toxicities. Participants will complete: * Baseline visit with assessments and CT or MRI scan. * CT or MRI scans every 12 weeks * Cycle 1 through End of Treatment: * Days 1 - 14 and 22 - 35 of 42-day Cycle: Predetermined dose of M1774 1x daily. * Days 1, 15, 29 of 42-day Cycle: Predetermined dose of Avelumab 1x daily. * End of Treatment visit with with CT or MRI scan * 30 day post-treatment follow up visit * 90 day post-treatment follow up * Long term follow up every 6 months for up to 3 years.

Primary Outcome Measure

Progression Free Survival at 6 months (PFS6) [ Time Frame: The observation period related to this endpoint is up to 6 months. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Panagiotis Konstantinopoulos, MD, PhD
[email protected]
617-632-5269
Panagiotis Konstantinopoulos, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02115
Panagiotis A Konstantinopoulos, MD, PhD
[email protected]
617-632-5269
Panagiotis A Konstantinopoulos, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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