← Back to Search

Monoclonal Antibodies

Avelumab and M1774 for Endometrial Cancer

Phase 2
Waitlist Available
Research Sponsored by Panagiotis Konstantinopoulos, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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 caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the observation period related to this endpoint is up to 5 years.
Awards & highlights

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)

Eligible Conditions
  • Endometrial Cancer
  • ARID1A Mutation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the observation period related to this endpoint is up to 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the observation period related to this endpoint is up to 5 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR)
Progression Free Survival at 6 months (PFS6)
Secondary study objectives
Grade 3-5 Treatment-Related Toxicity Rate
Immune-Related Overall Response Rate(irORR)
Median Immune-related Progression-free Survival (irPFS)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Avelumab and M1774Experimental Treatment2 Interventions
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 3 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

The Applebaum FoundationUNKNOWN
1 Previous Clinical Trials
306 Total Patients Enrolled
Panagiotis Konstantinopoulos, MD, PhDLead Sponsor
EMD SeronoIndustry Sponsor
144 Previous Clinical Trials
27,203 Total Patients Enrolled
~17 spots leftby Aug 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top