RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2021-10-20

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04486352

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Quality Management and Compliance

CONTACT

617-732-8727

ClinicalTrials.Queries@alliancefoundationtrials.org

Study Locations (Sites)

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, 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

Saint 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

Collaborators and Investigators

Sponsor: Alliance Foundation Trials, LLC.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-20

Study Completion Date2026-10

Study Record Updates

Study Start Date2021-10-20

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

Endometrial Cancer