Cabozantinib + Atezolizumab for Prostate Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial tests whether cabozantinib and atezolizumab work to shrink tumors in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and atezolizumab may kill more tumor cells in patients with metastatic castrate-resistant prostate cancer.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have received certain treatments like chemotherapy, immunotherapy, or kinase inhibitors shortly before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What data supports the effectiveness of the drug combination of Cabozantinib and Atezolizumab for prostate cancer?
Research shows that Cabozantinib, when combined with Atezolizumab, has shown promising results in treating metastatic castration-resistant prostate cancer, especially in patients who have limited options after other hormone therapies. Cabozantinib is known to enhance the immune response, which may improve the effectiveness of Atezolizumab, an immune checkpoint inhibitor.12345
Is the combination of Cabozantinib and Atezolizumab generally safe for humans?
Atezolizumab has been used in various cancer treatments and is generally considered to have a manageable safety profile. Common side effects include fatigue, decreased appetite, and nausea, while more serious effects can include lung inflammation, liver inflammation, and thyroid issues. The safety of Cabozantinib in combination with Atezolizumab specifically for prostate cancer may not be fully established, but both drugs have been used safely in other cancer treatments.678910
How is the drug combination of Cabozantinib and Atezolizumab unique for treating prostate cancer?
The combination of Cabozantinib and Atezolizumab is unique because Cabozantinib, a drug that blocks certain proteins involved in cancer growth, works with Atezolizumab, an immune system booster, to potentially enhance the body's ability to fight prostate cancer. This approach is being tested for patients with advanced prostate cancer who have limited treatment options after other therapies.123411
Research Team
Umang Swami, MD
Principal Investigator
Huntsman Cancer Institute/ University of Utah
Eligibility Criteria
Men aged 18+ with metastatic castration-resistant prostate cancer that has spread and progressed despite hormone therapy. They must have certain blood, liver, and kidney function levels, agree to contraception use, not have had certain recent treatments or other cancers within 3 years, no severe illnesses or infections, and be able to follow the study plan.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cabozantinib orally once daily on days 1-21 and atezolizumab intravenously on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 3 months until disease progression or start of another therapy.
Treatment Details
Interventions
- Atezolizumab
- Cabozantinib S-malate
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
National Cancer Institute (NCI)
Collaborator