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NCT04486352RecruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
148 (estimated)
First submitted
22 Jul 2020
Start date
20 Oct 2021
Primary completion date
1 Oct 2026
Lead sponsor
Alliance Foundation Trials, LLC.
NCT number
NCT04486352

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 148
  • From 20 Oct 2021 to the primary completion date, 1 Oct 2026
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Have received therapeutic oral or IV antibiotic medication within 2 weeks, except prophylactic antibiotic medication
  • 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
    • AFT-50A Specific Exclusion Criteria:
    • ● Prior treatment with T-cell costimulating or immune checkpoint blockade therapies including, but not limited to, CD137 agonists, anti-PD-1, anti-PD-L1, and anti-CTLA-4 therapeutic antibodies
    • Note: Additional study cohort specific inclusion and exclusion criteria may apply based on cohort assignment.

Other illness

  • 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 significant cardiovascular disease

Other

  • Endometrial tumors with the following histologies: squamous carcinomas, sarcomas

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesActive, not recruiting
Roswell Park
Coordinator of this site? Confirm its status
BuffaloUnited StatesActive, not recruiting
University of Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesActive, not recruiting
City of Hope Comprehensive Cancer Center
Coordinator of this site? Confirm its status
DuarteUnited StatesActive, not recruiting
Duke University Cancer Center
Coordinator of this site? Confirm its status
DurhamUnited StatesActive, not recruiting
Englewood Health
Coordinator of this site? Confirm its status
EnglewoodUnited StatesActive, not recruiting
Baptist Memorial Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesWithdrawn
Mount Sinai Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Miami BeachUnited StatesActive, not recruiting
University of Minnesota
Coordinator of this site? Confirm its status
MinneapolisUnited StatesActive, not recruiting
Atlantic Health Systems/Morristown Medical Center
Coordinator of this site? Confirm its status
MorristownUnited StatesActive, not recruiting
Weill Cornell Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesActive, not recruiting
University of Oklahoma Health Stephenson Cancer Center
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesRecruiting
Nebraska Methodist Hospital
Coordinator of this site? Confirm its status
OmahaUnited StatesActive, not recruiting
University of Pittsburgh Medical Center
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PittsburghUnited StatesActive, not recruiting
Providence Portland Cancer Institute
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PortlandUnited StatesActive, not recruiting
Lifespan / Rhode Island Hospital
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ProvidenceUnited StatesActive, not recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
Coordinator of this site? Confirm its status
San FranciscoUnited StatesActive, not recruiting
Maine Medical Center
Coordinator of this site? Confirm its status
ScarboroughUnited StatesActive, not recruiting
Washington University School of Medicine - Siteman Cancer Center
Coordinator of this site? Confirm its status
St LouisUnited StatesWithdrawn
Medstar Georgetown Cancer Institute
Coordinator of this site? Confirm its status
Washington D.C.United StatesActive, not recruiting
University of Kansas Cancer Center
Coordinator of this site? Confirm its status
WestwoodUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.