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
Alliance Foundation Trials, LLC.
148 participants
Oct 20, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria15
- 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
- ● 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
Interventions
Atezolizumab will be given to participants intravenously at a dosage of 1680 mg on day 1 of each 28-day cycle.
Bevacizumab will be given to participants intravenously at a dosage of 10mg per participant kilogram every 2 weeks of the 28-day cycle.
Ipatasertib will be given as an orally at a dosage of 400 mg once daily for 21 days of each 28-day cycle.
Talazoparib will be given in an orally at a dosage of 1 mg once daily for each day of the 28-day cycle.
Trastuzumab emtansine be given to participants intravenously at a dosage of 3.6 mg per participant kilogram, on day 1 of each 21-day cycle.
Tiragolumab will be given to participants intravenously at a dosage of 840 mg on day 1 of each 28-day cycle.
Atezolizumab will be given to participants intravenously at a dosage of 1200 mg on day 1 of each 21-day cycle.
Inavolisib will be given in an orally at a dosage of 9 mg once daily for each day of the 28-day cycle.
Letrozole will be given orally at a dosage of 2.5 mg once daily for each day of the 28-day cycle.
Giredestrant will be given orally at a dosage of 30 mg once daily for each day of the 28-day cycle.
Giredestrant will be given orally at a dosage of 150 mg twice daily for each day of the 28-day cycle.
Locations(21)
View Full Details on ClinicalTrials.gov
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NCT04486352