Study on Pembrolizumab With or Without Axitinib for Treating Advanced Kidney Cancer in Patients Undergoing Surgery
Sponsor: University of California, San Francisco
ClinicalTrials ID:NCT04370509
This clinical trial is exploring how well the drug pembrolizumab, with or without axitinib, works in treating patients with advanced kidney cancer who are undergoing surgery. The study aims to see if these treatments can better control the cancer and reduce the chance of it returning after surgery compared to the usual treatment.
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Program Overview
This phase II study is investigating the effectiveness of pembrolizumab, an immune therapy drug, with or without axitinib, a targeted therapy drug, in patients with clear cell kidney cancer that has spread locally or to other parts of the body. The trial aims to determine if these treatments can improve cancer control and decrease the likelihood of recurrence after surgery, compared to the standard treatment of surgery followed by chemotherapy or radiation.
Description
The main goal of this study is to see how pembrolizumab affects the immune cells within kidney tumors in patients undergoing surgery to remove the cancer. Researchers also want to evaluate how effective pembrolizumab is when given before and after surgery, and to assess its safety and tolerability.
Patients will be divided into two groups:
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Cohort A: Patients receive pembrolizumab through an IV every 21 days for 3 cycles before surgery. After surgery, patients with no visible disease or only microscopic disease will continue to receive pembrolizumab every 42 days for up to 9 cycles (1 year). Those with visible disease will receive pembrolizumab every 42 days for up to 18 cycles (2 years).
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Cohort B: Patients receive pembrolizumab through an IV and axitinib orally twice daily for 3 cycles before surgery. After surgery, patients with no visible disease or only microscopic disease will continue to receive both pembrolizumab and axitinib every 42 days for up to 9 cycles (1 year). Those with visible disease will receive both drugs every 42 days for up to 18 cycles (2 years).
Follow-up visits will occur after treatment ends, 30 days later, and then every 12 weeks for up to a year. Patients who stop participating due to disease progression will have a safety follow-up visit within 30 days after their last treatment dose.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with clear cell kidney cancer that is locally advanced or has spread to other parts of the body.
- Planning to undergo surgery to remove the kidney tumor or metastases.
- Must have a tumor that can be biopsied before treatment.
- Must have measurable disease according to specific criteria.
- Must be 18 years or older.
- Must have a good performance status and adequate organ function based on specific lab tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 120 days after the last dose.
Exclusion Criteria
- Kidney cancer without a clear cell component.
- Previous systemic therapy for kidney cancer.
- No measurable disease.
- Not eligible for surgery to remove the tumor or metastases.
- Currently participating in another investigational study or have used an investigational device recently.
- Have an active infection or other serious medical conditions.
- Pregnant or breastfeeding women.
- History of severe allergic reactions to pembrolizumab or axitinib.
- Have received certain treatments or have certain medical conditions that could interfere with the study.
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