RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy

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.

NCT Number	NCT07218692
Lead Sponsor	City of Hope Medical Center Collaborators: National Cancer Institute (NCI)
Conditions	Advanced Clear Cell Renal Cell Carcinoma, Advanced Renal Cell Carcinoma, Advanced Sarcomatoid Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Metastatic Sarcomatoid Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8 +1 more
Enrollment	35 participants
Start Date	2026-08-11
Primary Completion	2027-08-11 (estimated)
Study Completion	2027-08-11 (estimated)
Updated on ClinicalTrials.gov	2025-10-20