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…