RecruitingPhase 1Phase 2NCT04486352

A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

A Phase IB/II Multi-Cohort Study of Targeted Agents and/or Immunotherapy With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer


Sponsor

Alliance Foundation Trials, LLC.

Enrollment

148 participants

Start Date

Oct 20, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of targeted agents with or without cancer immune checkpoint therapy with atezolizumab in participant with recurrent and/or persistent endometrial cancer. The main protocol provides a platform for genomic screening with homogeneous basic eligibility criteria in order to direct study participants into biomarker-matched study cohorts consisting of testing targeted agents.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests targeted therapies matched to specific genetic features in tumors of women with recurrent or persistent endometrial (uterine) cancer that has returned after treatment. Rather than using standard one-size-fits-all chemotherapy, the treatment is selected based on the unique molecular profile of each patient's tumor. **You may be eligible if...** - You have endometrial cancer that has come back or not gone away after 1–2 prior lines of treatment - Your tumor has measurable disease visible on imaging - A tissue sample from your tumor is available (or you had a recent genomic test called F1CDx) - You are 18 or older with adequate organ function **You may NOT be eligible if...** - You have received more than 2 prior treatment regimens - You have had prior treatment with the specific targeted therapy being tested - You have significant heart disease or poorly controlled other illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab - 28 Day Cycle

Atezolizumab will be given to participants intravenously at a dosage of 1680 mg on day 1 of each 28-day cycle.

DRUGBevacizumab

Bevacizumab will be given to participants intravenously at a dosage of 10mg per participant kilogram every 2 weeks of the 28-day cycle.

DRUGIpatasertib

Ipatasertib will be given as an orally at a dosage of 400 mg once daily for 21 days of each 28-day cycle.

DRUGTalazoparib

Talazoparib will be given in an orally at a dosage of 1 mg once daily for each day of the 28-day cycle.

DRUGTrastuzumab emtansine

Trastuzumab emtansine be given to participants intravenously at a dosage of 3.6 mg per participant kilogram, on day 1 of each 21-day cycle.

DRUGTiragolumab

Tiragolumab will be given to participants intravenously at a dosage of 840 mg on day 1 of each 28-day cycle.

DRUGAtezolizumab - 21 Day Cycle

Atezolizumab will be given to participants intravenously at a dosage of 1200 mg on day 1 of each 21-day cycle.

DRUGInavolisib

Inavolisib will be given in an orally at a dosage of 9 mg once daily for each day of the 28-day cycle.

DRUGLetrozole

Letrozole will be given orally at a dosage of 2.5 mg once daily for each day of the 28-day cycle.

DRUGGiredestrant

Giredestrant will be given orally at a dosage of 30 mg once daily for each day of the 28-day cycle.

DRUGAbemaciclib

Giredestrant will be given orally at a dosage of 150 mg twice daily for each day of the 28-day cycle.


Locations(21)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Medstar Georgetown Cancer Institute

Washington D.C., District of Columbia, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

University of Chicago

Chicago, Illinois, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Maine Medical Center

Scarborough, Maine, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Englewood Health

Englewood, New Jersey, United States

Atlantic Health Systems/Morristown Medical Center

Morristown, New Jersey, United States

Roswell Park

Buffalo, New York, United States

Weill Cornell Medicine

New York, New York, United States

Duke University Cancer Center

Durham, North Carolina, United States

University of Oklahoma Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Providence Portland Cancer Institute

Portland, Oregon, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Lifespan - Rhode Island Hospital

Providence, Rhode Island, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT04486352


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