Axitinib + Anti-OX40 Antibody for Kidney Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you should avoid using strong CYP3A4/5 inhibitors (a type of enzyme blocker) and certain steroids, as they may interfere with the study drugs. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug Axitinib + Anti-OX40 Antibody for kidney cancer?
Axitinib has been shown to be effective in treating advanced kidney cancer, especially in patients who have already tried other treatments. It works by blocking certain proteins that help cancer cells grow, and has been used successfully in combination with other drugs to improve patient outcomes.12345
Is the combination of Axitinib and Anti-OX40 Antibody safe for humans?
Axitinib, also known as Inlyta, has been studied for safety in patients with advanced kidney cancer. Common side effects include diarrhea, high blood pressure, fatigue, decreased appetite, nausea, voice changes, hand-foot syndrome, and low thyroid function. The safety of the Anti-OX40 Antibody in combination with Axitinib specifically is not detailed in the provided research.13456
What makes the drug Axitinib + Anti-OX40 Antibody unique for kidney cancer?
This treatment combines Axitinib, a drug that blocks specific proteins (VEGF receptors) to stop cancer growth, with an Anti-OX40 Antibody, which may enhance the immune system's ability to fight cancer. This combination is unique because it targets both the cancer cells directly and boosts the body's immune response, offering a potentially more effective approach than using either component alone.13578
What is the purpose of this trial?
This randomized phase II trial studies how well axitinib with or without anti-OX40 antibody PF-04518600 work in treating patients with kidney cancer that has spread to other parts of the body. Biological therapies, such as anti-OX40 antibody PF-04518600, use substances made from living organisms that may may stimulate the immune system in different ways and stop tumor cells from growing. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib with or without anti-OX40 antibody PF-04518600 may work better in treating patients with kidney cancer.
Research Team
Sarmad Sadeghi
Principal Investigator
University of Southern California
Eligibility Criteria
This trial is for adults with metastatic kidney cancer who've had a nephrectomy, have measurable disease, and proper organ function. They must not be pregnant or breastfeeding, use effective contraception, and can't have brain metastases requiring steroids, active autoimmune diseases, recent major surgeries or certain medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive axitinib orally twice daily and either anti-OX40 antibody PF-04518600 or placebo intravenously, with courses repeating every 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Anti-OX40 Antibody PF-04518600
- Axitinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
National Cancer Institute (NCI)
Collaborator