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

NCT07218692 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-10-20

No results posted yet for this study

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.

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
  • Stage IV Renal Cell Cancer AJCC v8

Interventions

PROCEDURE

Biopsy Procedure

Undergo tumor biopsies

PROCEDURE

Biospecimen Collection

Undergo urine and blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Sturlimogene Erparepvec

Given intratumorally

DRUG

Tivozanib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Charles B Nguyen · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-11
Primary Completion
2027-08-11
Completion
2027-08-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07218692 on ClinicalTrials.gov