Study on RP2 and Tivozanib for Treating Metastatic Kidney Cancer After Immunotherapy
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT07218692
This clinical trial is exploring a new treatment using RP2, a modified virus, and tivozanib, a medication, to help patients with kidney cancer that has spread and worsened after immunotherapy. The study aims to see if this combination is safe and effective.
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Program Overview
This phase II study is testing the effects of RP2 and tivozanib in patients with kidney cancer that has spread to other parts of the body and has progressed after immunotherapy. RP2 is a modified herpes virus designed to attack cancer cells and boost the immune system. Tivozanib is a drug that blocks proteins to stop cancer growth and prevent new blood vessels from forming. The study will determine if this combination is safe and effective for treating metastatic kidney cancer after immunotherapy.
Description
The main goal of this study is to see how well the combination of RP2 and tivozanib works in shrinking tumors in patients with metastatic kidney cancer that has progressed after immunotherapy. The study will also look at the safety and side effects of this treatment.
Patients will receive RP2 injections directly into the tumor on specific days over several months. Tivozanib will be taken as a daily pill for 21 days in each 28-day cycle. The treatment will continue as long as it is effective and does not cause unacceptable side effects. Patients will have regular CT scans and provide blood and urine samples to monitor their response to the treatment. Tumor biopsies may also be performed.
After finishing the treatment, patients will have follow-up visits at 30 days and then every three months for up to three years to check their health and the long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent to participate.
- Willing to provide a recent or archived tumor biopsy sample.
- Aged 18 or older.
- Good overall health with an ECOG score of 0 or 1.
- Diagnosed with kidney cancer with clear-cell or sarcomatoid features.
- Previously treated with one or two lines of therapy, including an immune checkpoint inhibitor and a tyrosine kinase inhibitor.
- Have tumors that can be injected with RP2 and at least one measurable tumor.
- Recovered from previous cancer treatments.
- Meet specific blood count and organ function requirements.
- Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for a specified time after.
- Men must agree to use birth control and not donate sperm during the study and for a specified time after.
Exclusion Criteria
- Received a live vaccine within 28 days before starting the study.
- Participating in another clinical trial or using an investigational device within four weeks before starting the study.
- Recent systemic cancer treatments or radiotherapy.
- Previous treatment with oncolytic virus therapy.
- Unstable heart conditions or recent heart attack.
- Allergies to study drugs or components.
- Active infections like HIV, hepatitis B, or C.
- Significant uncontrolled illnesses or infections.
- Active herpetic infections or need for antiherpetic medications.
- Recent significant bleeding events.
- Other active cancers that could interfere with the study.
- Brain metastases or certain lung diseases.
- Active tuberculosis or autoimmune diseases requiring treatment.
- Recent major surgery or planning major surgery during the study.
- Pregnant or breastfeeding women.
- Conditions that could interfere with the study or patient safety.
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