Phase II Study of Atezolizumab and Bevacizumab for Advanced Endometrial Cancer
Sponsor: University of Oklahoma
ClinicalTrials ID:NCT03526432
This clinical trial is testing a combination of two drugs, atezolizumab and bevacizumab, to see if they are safe and effective in treating women with advanced, recurring, or persistent endometrial cancer.
Patient Parameters
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Program Overview
The study aims to find out if the combination of atezolizumab and bevacizumab can help control endometrial cancer that has come back or is not responding to other treatments. Participants will receive these drugs through an IV every 21 days until the cancer progresses, side effects become too severe, or the treatment is no longer beneficial. The study will also involve regular cancer care and additional tests to monitor the effects of the treatment.
Description
This Phase II study is focused on women with endometrial cancer that has returned or is not responding to other treatments. The treatment involves two drugs, atezolizumab and bevacizumab, given through an IV every 21 days. The goal is to see if this combination can shrink tumors and manage the cancer with acceptable side effects. Participants will continue to receive standard cancer care and undergo tests and procedures to track the treatment's impact. The study hopes to show that this drug combination can effectively fight cancer while keeping side effects manageable.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with endometrial cancer, including specific types like endometrioid or serous carcinoma.
- Cancer must be advanced, recurring, or persistent and not responding to standard treatments.
- Have had at least one, but no more than two, previous chemotherapy treatments for endometrial cancer.
- Have at least one tumor that can be measured by scans or exams.
- Female, aged 18 or older.
- In good general health, with an activity level that allows for light work.
- Agree to use birth control or abstain from sex if of childbearing potential.
- Meet specific lab test requirements before starting the study.
- Understand and agree to the study's requirements and sign a consent form.
- Have known MSI status and provide a tumor sample for study purposes.
- Have a life expectancy of more than 12 weeks.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Previous treatment with certain immune therapy drugs.
- History of autoimmune diseases like lupus or rheumatoid arthritis.
- Recent use of systemic steroids.
- Significant nerve damage or neuropathy.
- Untreated or symptomatic brain metastases.
- Serious health conditions that could interfere with the study.
- Recent diagnosis or treatment for another cancer, except for certain skin cancers.
- Previous organ or bone marrow transplants.
- Recent participation in other clinical trials or treatments.
- Severe allergies to similar drugs or components.
- Recent major surgery or serious abdominal issues.
- Immunocompromised individuals or those with active HIV on treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UAB Women and Infants Center | 35233 | Birmingham | Alabama |
| Washington University School of Medicine | 63108 | St Louis | Missouri |
| Stephenson Cancer Center, University of Oklahoma Health Sciences Center | 73117 | Oklahoma City | Oklahoma |
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