A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
Start Date
10/20/2021
Completion Date
10/1/2027
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.
Detailed Description
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 participants with recurrent and/or persistent endometrial cancer. This biomarker-driven study provides a platform whereby participants with persistent/recurrent endometrial cancer will be placed into study cohorts evaluating targeted agents selected on the basis of the tumor's specific genomic profile. Prospective participants with persistent and/or recurrent endometrial cancer will be prescreened within 60 days of treatment assignment to have a tumor tissue sample submitted for next-generation sequencing (NGS) using FoundationOne® companion diagnostic (CDx) testing prior to entering screening. If a participant has FoundationOne® CDx testing within five years of enrollment, the previous tumor tissue may be re-analyzed for use in the study. Non-FMI NGS testing may be submitted if approved. Depending on the cohort assignment per the tumor's biomarker profile, participants will be assigned to the AFT-50A Protocol (atezolizumab+targeted agent) or the AFT-50B Protocol (non-atezolizumab targeted agents). The current study cohorts are as follows: AFT-50A Cohorts * Atezolizumab + Bevacizumab doublet - Closed to Accrual * Atezolizumab + Ipatasertib doublet - Closed to Accrual * Atezolizumab + Talazoparib doublet * Atezolizumab + Trastuzumab emtansine (TDM-1) doublet - Closed to Accrual * Atezolizumab + Tiragolumab doublet - Closed to Accrual AFT-50B Cohorts * Inavolisib + Letrozole doublet * Giredestrant + Abemaciclib doublet It is anticipated that approximately 20 participants will be enrolled in each study cohort in AFT-50A and 24 participants in each study cohort in AFT-50B, unless otherwise specified for a given cohort due to statistical considerations. Each study cohort will open/close independently of other study cohorts. Once a study cohort reaches the prespecified number of participants, it will be closed to further enrollment, unless an expansion phase is planned. The study is structured to allow for additional cohorts to be added as the study progresses. These additional study cohorts may be proposed by investigators, but requires approval by the Steering Committee in order to be added to the protocol.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Atezolizumab - 28 Day Cycle
Bevacizumab
Ipatasertib
Talazoparib
Trastuzumab emtansine
Tiragolumab
Atezolizumab - 21 Day Cycle
Inavolisib
Letrozole
Giredestrant
Abemaciclib
Conditions
Locations
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94143
United States
Medstar Georgetown Cancer Institute
Washington D.C., District of Columbia 20007
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United States
University of Chicago
Chicago, Illinois 60637
United States
University of Kansas Cancer Center
Westwood, Kansas 66205
United States
Maine Medical Center
Scarborough, Maine 04074
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02125
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri 63110
United States
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United States
Englewood Health
Englewood, New Jersey 07631
United States
Atlantic Health Systems/Morristown Medical Center
Morristown, New Jersey 07960
United States
Roswell Park
Buffalo, New York 14263
United States
Weill Cornell Medicine
New York, New York 10065
United States
Duke University Cancer Center
Durham, North Carolina 27710
United States
University of Oklahoma Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Providence Portland Cancer Institute
Portland, Oregon 97213
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15261
United States
Lifespan - Rhode Island Hospital
Providence, Rhode Island 02903
United States
Baptist Memorial Hospital
Memphis, Tennessee 38120
United States