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Targeted treatments for recurrent 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

Phase1; Phase2 Interventional Alliance Foundation Trials, LLC. · NCT04486352

This study is testing different targeted treatments, with or without an immune therapy, to see if they can help people with recurrent endometrial cancer based on their tumor's genetic makeup.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment148 (estimated)
Ages18 Years and up
SexFemale
SponsorAlliance Foundation Trials, LLC. Academic / other
Drugs / interventionsChemotherapy, atezolizumab, Bevacizumab, Trastuzumab, Tiragolumab
Locations21 sites (Duarte, California and 20 other locations)
Trial IDNCT04486352 on ClinicalTrials.gov

What this trial studies

This Phase IB/II multi-cohort study evaluates the efficacy and safety of targeted agents, with or without the immune checkpoint therapy atezolizumab, in patients with recurrent or persistent endometrial cancer. Participants will undergo genomic screening to match them with specific biomarker-driven cohorts for targeted treatment. The study includes various combinations of therapies, allowing for personalized treatment based on the tumor's genomic profile. Patients will be prescreened to ensure eligibility and appropriate treatment assignment.

Who should consider this trial

Good fit: Ideal candidates are patients with recurrent or persistent endometrial carcinoma who have progressed after one or two prior lines of therapy.

Not a fit: Patients with endometrial cancer that has not recurred or progressed after initial treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide personalized treatment options that improve outcomes for patients with recurrent endometrial cancer.

How similar studies have performed: Other studies using biomarker-driven approaches in cancer treatment have shown promising results, indicating potential success for this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion 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

Key Exclusion Criteria:

* 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

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.

Where this trial is running

Duarte, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Endometrial Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.