Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
Study NCT ID:
NCT07218692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
A Phase 2 Study of RP2 With Tivozanib in Patients With Metastatic Renal Carcinoma After Progression to Immunotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 RP2 with tivozanib as a subsequent line treatment.
III. To determine the progression-free survival (PFS) 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.
IV. To determine the overall survival (OS) 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.
OUTLINE:
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 orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and urine and blood sample collection throughout the study. Additionally, patients may undergo tumor biopsies throughout the study.
After completion of study treatment, patients are followed up at 30 days then every 3 months for up to 3 years.
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 RP2 with tivozanib as a subsequent line treatment.
III. To determine the progression-free survival (PFS) 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.
IV. To determine the overall survival (OS) 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.
OUTLINE:
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 orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and urine and blood sample collection throughout the study. Additionally, patients may undergo tumor biopsies throughout the study.
After completion of study treatment, patients are followed up at 30 days then every 3 months for up to 3 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-07332 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 25317 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |