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A Study of Targeted Agents for Recurrent or Persistent Endometrial Cancer

This study is for women with endometrial cancer that has come back or continued after at least one, but no more than two, previous treatments. It aims to test how well different targeted drugs work, either alone or with atezolizumab, which is a type of immunotherapy. The drugs being tested include atezolizumab, bevacizumab, ipatasertib, talazoparib, and trastuzumab emtansine. Before joining, your tumor tissue will be checked to see which drugs might work best for you. Researchers will look at how many participants respond to the treatment and how many stay alive without their cancer getting worse for at least 6 months. This study plans to enroll 148 participants.

Study design
This is a Phase IB/II multi-cohort study that will assign participants to different treatment groups based on their tumor's genetic profile. It is an interventional study with a planned enrollment of 148 participants.
What's involved
Participants will receive study drugs intravenously or orally in cycles lasting 21 or 28 days. Tumor tissue samples will be submitted for genetic testing before treatment assignment.
Compensation
Not stated in the trial record.
Follow-up
Researchers will assess how participants respond to treatment over 48 months and track how many remain alive and progression-free for at least 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04486352

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Alliance Foundation Trials, LLC.
~148 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Atezolizumab - 28 Day CycleBevacizumabIpatasertibTalazoparibTrastuzumab emtansineTiragolumab

At a glance

Recruiting sites
1 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Investigator-assessed overall response rate (ORR) of each biomarker cohort
Measured over 48 Months
+1 more outcome measured

Conditions

Endometrial Cancer

Explore related trials

Endometrial Carcinoma

Where it's being run

21 sites across 18 states
California2
New Jersey2
New York2
District of Columbia1
Florida1
Illinois1
Kansas1
Maine1

Who to contact

Quality Management and Compliance
[email protected]
617-732-8727
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Investigator-assessed overall response rate (ORR) of each biomarker cohort48 Months

    AFT-50A Protocol: Overall response rate for each biomarker cohort is defined as the proportion of participants achieving a complete (CR) or partial (PR) response on two consecutive occasions at least 4 weeks apart, as determined by the investigator from AFT50A Protocol: Tumor assessments per RECIST v1.1.

  • The proportion of participants in each biomarker cohort who remain alive and progression-free for at least 6 months6 Months

    AFT-50B Protocol: Progression free survival rate at 6 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months, as determined by the investigator according to RECIST v1.1