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Monoclonal Antibodies

Avelumab + 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 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.
ECOG performance status 0, 1, or 2.
Must not have
Participants with certain brain metastases conditions or meningeal carcinomatosis.
Vaccination within 4 weeks of treatment initiation and while on trial is prohibited.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the observation period related to this endpoint is up to 5 years.
Awards & highlights

Summary

This trial aims to determine if a combination of two drugs, avelumab and M1774, is safe and effective for treating endometrial cancer. This trial will test how well these

Who is the study for?
This trial is for individuals with endometrial cancer that has returned and have a specific genetic change called an ARID1A mutation. Details on who can join or reasons why someone might not be able to participate are not provided.
What is being tested?
The study is testing the effectiveness and safety of combining two drugs, Avelumab (an antibody) and M1774 (an ATR inhibitor), in treating endometrial cancer with ARID1A mutations.
What are the potential side effects?
Specific side effects are not listed, but as an antibody, Avelumab may cause immune-related reactions, while M1774 could lead to typical chemotherapy side effects like fatigue, nausea, or blood cell changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My endometrial cancer has a specific genetic change known as ARID1A mutation.
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I can care for myself and perform daily activities.
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I can provide a tissue sample from my cancer surgery or biopsy.
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I have previously received immunotherapy targeting PD-1/PD-L1.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases or meningeal carcinomatosis.
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I have not been vaccinated within the last 4 weeks and won't get vaccinated during the trial.
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My heart's electrical cycle is longer than normal and not corrected by treating mineral imbalances.

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
2017
Completed Phase 2
~2440

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
27,703 Total Patients Enrolled
~17 spots leftby Aug 2027
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