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

• Status: Recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of targeted agents plus cancer immune checkpoint therapy with atezolizumab for patients 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 subjects into biomarker-matched study cohorts consisting of testing targeted agents with atezolizumab.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance Foundation Trials, LLC.
• Collaborators: Foundation Medicine; Genentech, Inc.; Pfizer
• Treatments: Atezolizumab; Bevacizumab; Talazoparib

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

• Formalin-fixed, paraffin-embedded tumor tissue, a specimen as proximal to the current recurrence as possible, must be submitted to the Central Lab for molecular testing (FoundationOne® assay).

• 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

• localized breast cancer with previous adjuvant chemotherapy treatment for breast cancer completed > 5 years ago

• Have 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

• Have active tuberculosis

• Have 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

• 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

• Have 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

• Have 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 patients 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