A Phase 2 Study of RP2 With Tivozanib in Patients With Metastatic Renal Carcinoma After Progression to Immunotherapy
City of Hope Medical Center
Summary
This phase II trial tests the effect of RP2 and tivozanib in treating patients with renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that is growing, spreading, or getting worse (progressive) after receiving immunotherapy with immune checkpoint inhibitors (ICIs). RP2 is a herpes simplex virus (a viral infection commonly known as the "cold sore virus") that has been changed to infect and destroy tumor cells and to activate (turn on) the human immune system to attack the tumor cells. Tivozanib hydrochloride blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Tivozanib hydrochloride is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Giving RP2 and tivozanib may be safe, tolerable, and/or effective in treating patients with metastatic renal cell cancer that has progressed after receiving immunotherapy with ICIs.
Description
PRIMARY OBJECTIVE: I. To assess the overall response rate (ORR) of the combination of sturlimogene erparepvec (RP2) with tivozanib in patients with metastatic clear cell renal carcinoma after immediate progression to first-line immunotherapy with an anti-PD1 antibody. SECONDARY OBJECTIVES: I. To characterize the safety and toxicity associated with the combination therapy of RP2 with tivozanib in patients with metastatic clear cell renal carcinoma after immediate progression to first-line immunotherapy with an anti-PD1 antibody. II. To characterize the population of patients that receive RP…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Must be willing to consent to provide fresh tumor biopsy sample or archival tumor biopsy sample obtained within 90 days before the first dose of study treatment * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Male or female who is 18 years of age or older at the time of signed informed consent * Eastern Cooperative Oncology Group (ECOG) 0 or 1 * Histologicall…
Interventions
- ProcedureBiopsy Procedure
Undergo tumor biopsies
- ProcedureBiospecimen Collection
Undergo urine and blood sample collection
- ProcedureComputed Tomography
Undergo CT
- BiologicalSturlimogene Erparepvec
Given intratumorally
- DrugTivozanib
Given PO
Locations (2)
- City of Hope Medical CenterDuarte, California
- City of Hope at Irvine LennarIrvine, California