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.
- Diseases
- Endometrial cancer
- 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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Active, not recruiting |
| Roswell Park Coordinator of this site? Confirm its status | Buffalo | United States | Active, not recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Active, not recruiting |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Active, not recruiting |
| Duke University Cancer Center Coordinator of this site? Confirm its status | Durham | United States | Active, not recruiting |
| Englewood Health Coordinator of this site? Confirm its status | Englewood | United States | Active, not recruiting |
| Baptist Memorial Hospital Coordinator of this site? Confirm its status | Memphis | United States | Withdrawn |
| Mount Sinai Comprehensive Cancer Center Coordinator of this site? Confirm its status | Miami Beach | United States | Active, not recruiting |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Active, not recruiting |
| Atlantic Health Systems/Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Active, not recruiting |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
| University of Oklahoma Health Stephenson Cancer Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Nebraska Methodist Hospital Coordinator of this site? Confirm its status | Omaha | United States | Active, not recruiting |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Active, not recruiting |
| Providence Portland Cancer Institute Coordinator of this site? Confirm its status | Portland | United States | Active, not recruiting |
| Lifespan / Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Active, not recruiting |
| UCSF Helen Diller Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | San Francisco | United States | Active, not recruiting |
| Maine Medical Center Coordinator of this site? Confirm its status | Scarborough | United States | Active, not recruiting |
| Washington University School of Medicine - Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Withdrawn |
| Medstar Georgetown Cancer Institute Coordinator of this site? Confirm its status | Washington D.C. | United States | Active, not recruiting |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.