A Phase IB/II Multi-Cohort Study of Targeted Agents and/or Immunotherapy With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer
Who is this study for? Patients with Endometrial Cancer
What treatments are being studied? Atezolizumab
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy. Prior hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit. Chemotherapy given in conjunction with radiotherapy as a radiosensitizer will be counted as a systemic therapeutic regimen.
• Measurable disease per RECIST 1.1
• Availability of a representative tumor specimen that is suitable for determination of biomarker status via central testing (F1CDx) OR If a patient has a prior F1CDx report from 1 September 2019 or later, those NGS results can be used to determine biomarker status as long as the tumor tissue used in the report was obtained within 5 years prior to prescreening and appropriate signed consent is obtained from the patient.
• Life expectancy \> 12 weeks
• Recovery from effects of recent radiotherapy, surgery, or chemotherapy
Locations
United States
California
City of Hope Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Duarte
UCSF Helen Diller Family Comprehensive Cancer Center
RECRUITING
San Francisco
Washington, D.c.
Medstar Georgetown Cancer Institute
RECRUITING
Washington D.c.
Florida
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Illinois
University of Chicago
RECRUITING
Chicago
Kansas
University of Kansas Cancer Center
RECRUITING
Westwood
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Maine
Maine Medical Center
RECRUITING
Scarborough
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Missouri
Washington University School of Medicine Siteman Cancer Center
WITHDRAWN
St Louis
North Carolina
Duke University Cancer Center
RECRUITING
Durham
Nebraska
Nebraska Methodist Hospital
RECRUITING
Omaha
New Jersey
Englewood Health
ACTIVE_NOT_RECRUITING
Englewood
Atlantic Health Systems/Morristown Medical Center
RECRUITING
Morristown
New York
Roswell Park
ACTIVE_NOT_RECRUITING
Buffalo
Weill Cornell Medicine
RECRUITING
New York
Oklahoma
University of Oklahoma Health Stephenson Cancer Center
RECRUITING
Oklahoma City
Oregon
Providence Portland Cancer Institute
RECRUITING
Portland
Pennsylvania
University of Pittsburgh Medical Center
ACTIVE_NOT_RECRUITING
Pittsburgh
Rhode Island
Lifespan - Rhode Island Hospital
RECRUITING
Providence
Tennessee
Baptist Memorial Hospital
WITHDRAWN
Memphis
Contact Information
Primary
Quality Management and Compliance
ClinicalTrials.Queries@alliancefoundationtrials.org
617-732-8727
Time Frame
Start Date: 2021-10-20
Estimated Completion Date: 2027-10
Participants
Target number of participants: 148
Treatments
Experimental: Atezolizumab and Bevacizumab Cohort - Closed to Accrual
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with no specified gene signatures will be enrolled in this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Experimental: Atezolizumab and Ipatasertib Cohort - Closed to Accrual
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with PIK3CA/AKT1/PTEN-altered tumors will be enrolled in this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Experimental: Atezolizumab and Talazoparib Cohort
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that have a ≥16%genomic loss of heterozygosity (LOH) will be assigned to this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Experimental: Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort - Closed to Accrual
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that with an amplification of ERBB2/HER2 will be assigned to this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Experimental: Atezolizumab and Tiragolumab Cohort - Closed to Accrual
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumor type MSI-H and/or tTMB \>=10 mut/mb will be assigned to this cohort. Twenty participants will be enrolled initially. Once twenty participants are enrolled, the cohort may be expanded if a positive signal is shown. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Experimental: Inavolisib and Letrozole Cohort
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that with PIK3CA activating mutations in the absence of PTEN loss-of-function alterations or AKT1 activating mutations will be assigned to this cohort. Twenty-four participants will be enrolled. Once twenty-four participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Experimental: Giredestrant and Abemaciclib
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that are RB1 intact with a local grade 1-2 estrogne receptor positive (ER+) are assigned to this cohort. Twenty-four participants will be enrolled. Once twenty-four participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc., Eli Lilly and Company, Pfizer, Foundation Medicine
Leads: Alliance Foundation Trials, LLC.