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

ConditionsAdvanced Clear Cell Renal Cell CarcinomaAdvanced Renal Cell CarcinomaAdvanced Sarcomatoid Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMetastatic Renal Cell CarcinomaMetastatic Sarcomatoid Renal Cell CarcinomaRecurrent Renal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Received a live vaccine within 28 days before the first dose of study treatment

Note: Seasonal influenza vaccines for injection or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are generally inactivated vaccines and are allowed. Live/attenuated vaccines (such as the intranasal influenza vaccines) are not allowed

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment

Note: Patients who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo tumor biopsies

  • Biospecimen Collection

    Procedure/Surgery

    Undergo urine and blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Sturlimogene Erparepvec

    Biological/Vaccine

    Given intratumorally

  • Tivozanib

    Drug

    Given PO

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Treatment (RP2, tivozanib)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Objective response rate

Will be defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per the Response Evaluation Criteria in Solid Tumors version (v) 1.1. Will be calculated as the number of patients with CR or PR divided by the total number of treated and evaluable subjects. Will be summarized with 80% confidence intervals.

Time frame
Up to 2 years

Secondary outcomes

1

Progression-free survival (PFS)

Will be analyzed using Kaplan-Meier survival methods. Median PFS and corresponding 80% confidence intervals will be reported. Cox proportional hazards modeling may be used to estimate hazard ratios and corresponding confidence intervals, though formal comparisons are not powered. Results will be interpreted in an exploratory context.

Time frame
From start of treatment to progression or death, whichever occurs first, assessed up to 2 years
2

Overall survival (OS)

Will be analyzed using Kaplan-Meier methods. Median OS and associated 80% confidence intervals will be reported. Cox proportional hazards modeling may be used to estimate hazard ratios. Findings will be considered descriptive and interpreted cautiously due to the single-arm nature of the trial.

Time frame
From start of treatment to death from any cause, assessed up to 2 years
3

Incidence of adverse events (AEs)

AEs including grade 3 or greater AEs, serious AEs, and treatment-related AEs , immune-related AEs (irAEs), and AEs leading to treatment discontinuation will be assessed per Common Terminology Criteria for Adverse Events v 5.0. Will be summarized using descriptive statistics. Time to onset and resolution of irAEs will also be explored when applicable.

Time frame
Up to 30 days after last dose of study treatment
4

Baseline characteristics

Descriptive statistics and graphical summaries will be used to characterize the baseline demographic and clinical features of the study population, including measures of central tendency (mean, median) and frequency distributions for categorical variables.

Time frame
At baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: