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

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 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.

Conditions

Endometrial Cancer

Study Overview

Study Details

Study overview

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.

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

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

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Comprehensive Cancer Center, Duarte, California, United States, 91010

San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States, 94143

Washington

Medstar Georgetown Cancer Institute, Washington, District of Columbia, United States, 20007

Miami Beach

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States, 33140

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Westwood

University of Kansas Cancer Center, Westwood, Kansas, United States, 66205

Scarborough

Maine Medical Center, Scarborough, Maine, United States, 04074

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02125

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Saint Louis

Washington University School of Medicine Siteman Cancer Center, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Endometrial tumors with the following histologies: squamous carcinomas, sarcomas
  • * Other invasive malignancies within the last 5 years, except for non-melanoma skin cancer with no evidence of disease within the past 5 years AND localized breast cancer with previous adjuvant chemotherapy treatment for breast cancer completed \> 5 years ago
  • * Synchronous primary invasive ovarian or cervical cancer
  • * Have an active or history of autoimmune disease or immune deficiency
  • * Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis based on a screening chest computed tomography (CT) scan
  • * Active tuberculosis
  • * Severe infections within 4 weeks
  • * Have received therapeutic oral or IV antibiotic medication within 2 weeks, except prophylactic antibiotic medication
  • * Have significant cardiovascular disease
  • * Are administered treatment with a live attenuated vaccine within 4 weeks, or anticipation of need for such a vaccine during the course of the study
  • * Have prior allogeneic bone marrow transplantation or solid organ transplant
  • * History of treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment
  • * History of treatment with systemic immunosuppressive medications within 2 weeks except acute, low-dose, systemic immunosuppressant medications, corticosteroids for chronic obstructive pulmonary disease and asthma, or mineralocorticoids and low-dose corticosteroids for participants with orthostatic hypotension or adrenocortical insufficiency
  • * Have a history or clinical evidence of any untreated CNS disease, seizures not controlled with standard medical therapy, or history of cerebrovascular accident (stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alliance Foundation Trials, LLC.,

Study Record Dates

2026-10