What this study is
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.
What's being tested
- Atezolizumab - 28 Day Cycle
Intervention · DRUG
Atezolizumab will be given to participants intravenously at a dosage of 1680 mg on day 1 of each 28-day cycle.
- Bevacizumab
Intervention · DRUG
Bevacizumab will be given to participants intravenously at a dosage of 10mg per participant kilogram every 2 weeks of the 28-day cycle.
- Ipatasertib
Intervention · DRUG
Ipatasertib will be given as an orally at a dosage of 400 mg once daily for 21 days of each 28-day cycle.
- Talazoparib
Intervention · DRUG
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
Intervention · DRUG
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
Intervention · DRUG
Tiragolumab will be given to participants intravenously at a dosage of 840 mg on day 1 of each 28-day cycle.
- Atezolizumab - 21 Day Cycle
Intervention · DRUG
Atezolizumab will be given to participants intravenously at a dosage of 1200 mg on day 1 of each 21-day cycle.
- Inavolisib
Intervention · DRUG
Inavolisib will be given in an orally at a dosage of 9 mg once daily for each day of the 28-day cycle.
- Letrozole
Intervention · DRUG
Letrozole will be given orally at a dosage of 2.5 mg once daily for each day of the 28-day cycle.
- Giredestrant
Intervention · DRUG
Giredestrant will be given orally at a dosage of 30 mg once daily for each day of the 28-day cycle.
- Abemaciclib
Intervention · DRUG
Giredestrant will be given orally at a dosage of 150 mg twice daily for each day of the 28-day cycle.
Study details
- Official title
- A Phase IB/II Multi-Cohort Study of Targeted Agents and/or Immunotherapy With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer
- Sponsor
- Alliance Foundation Trials, LLC.
- Conditions
- Endometrial Cancer
- Enrolling
- 148 people
- Starts
- 2021-10-20
- Est. completion
- 2027-10
- Design
- Open-label, non-randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (21)
1 openUniversity of Oklahoma Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
- Debra Richardson, MD · Contact
- Debra Richardson, MD · Principal investigator
RecruitingCity of Hope Comprehensive Cancer Center
Duarte, California, United States
Active, not recruitingUCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Active, not recruitingMedstar Georgetown Cancer Institute
Washington D.C., District of Columbia, United States
Active, not recruitingMount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Active, not recruitingUniversity of Chicago
Chicago, Illinois, United States
Active, not recruitingUniversity of Kansas Cancer Center
Westwood, Kansas, United States
Active, not recruitingMaine Medical Center
Scarborough, Maine, United States
Active, not recruitingDana Farber Cancer Institute
Boston, Massachusetts, United States
Active, not recruitingUniversity of Minnesota
Minneapolis, Minnesota, United States
Active, not recruitingWashington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
WithdrawnNebraska Methodist Hospital
Omaha, Nebraska, United States
Active, not recruitingEnglewood Health
Englewood, New Jersey, United States
Active, not recruitingAtlantic Health Systems/Morristown Medical Center
Morristown, New Jersey, United States
Active, not recruitingRoswell Park
Buffalo, New York, United States
Active, not recruitingWeill Cornell Medicine
New York, New York, United States
Active, not recruitingDuke University Cancer Center
Durham, North Carolina, United States
Active, not recruitingProvidence Portland Cancer Institute
Portland, Oregon, United States
Active, not recruitingUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Active, not recruitingLifespan - Rhode Island Hospital
Providence, Rhode Island, United States
Active, not recruitingBaptist Memorial Hospital
Memphis, Tennessee, United States
Withdrawn
Study team
Sponsor
Alliance Foundation Trials, LLC.
Study ID AFT-50
CONTACT
Quality Management and Compliance
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.