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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07218692
Phase
PHASE2
Status
Not Yet Recruiting

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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsies
  • Biospecimen Collection — PROCEDURE
    Undergo urine and blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Sturlimogene Erparepvec — BIOLOGICAL
    Given intratumorally
  • Tivozanib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Aug 11, 2026
Status verified
Oct 2025
Primary completion
Aug 11, 2027
Completion
Aug 11, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (RP2, tivozanib)
    Patients receive RP2 intratumorally on days 1, 15, 29, 43, 64, 85, 106, and 127. Treatment repeats every 2 weeks for the first 4 doses and then every 3 weeks for subsequent doses for up to 8 doses in the absence of disease progression or unacceptable toxicity. After completion of the first course of treatment, patients who meet criteria may receive another course of RP2 intratumorally every 3 weeks for up to an additional 8 doses. Patients also receive tivozanib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and urine and blood sample collection throughout the study. Additionally, patients may undergo tumor biopsies throughout the study.

Primary Outcome Measure

Objective response rate [ Time Frame: Up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Charles B. Nguyen
[email protected]
Charles B. Nguyen (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618
Charles B. Nguyen
[email protected]
Charles B. Nguyen (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

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By specialty
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By research site
City of Hope Medical Center· Duarte, CACity of Hope at Irvine Lennar· Irvine, CA

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