NCT06661720|RecruitingPhase 3

Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer

STRIKE

Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

A032201NCI-2024-08233

Study Type

interventional

Target

1,040

Locations

1 country

Sites

399

Timeline

RegisteredOct 2024

StartedMar 2025

CompletionNov 2037

Brief Summary

This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,040

participants targeted

Target at P75+ for phase_3

Timeline

140mo left

Started Mar 2025

Longer than P75 for phase_3

Geographic Reach

1 country

399 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

12.6 years study duration

Study Progress9%

Mar 2025Nov 2037

First Submitted

Initial submission to the registry

October 25, 2024

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed

5 months until next milestone

Study Start

First participant enrolled

March 14, 2025

Completed

12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2037

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2037

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

12.6 years

First QC Date

October 25, 2024

Last Update Submit

March 2, 2026

Conditions

Clear Cell Renal Cell Carcinoma Renal Cell Carcinoma (RCC)Stage II Renal Pelvis Cancer AJCC v8 Stage III Renal Pelvis Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

Disease-free survival (DFS)
The primary analysis will be a comparison of DFS between the two study arms using a stratified log-rank test. The treatment effect will be estimated with a hazard ratio (HR) and corresponding 95% confidence interval obtained from a stratified Cox model with treatment group (experimental group versus control group) as the explanatory variable. Interim analyses: There will be several futility analyses for the trial. These analyses will employ the linear 20% method proposed by Freidlin, Korn and Gray. Based on the current design parameters, the first analysis would be performed at 37% information (99 DFS events), and the trial would be stopped for futility if the observed hazard ratio (experimental versus \[vs.\] control) were worse than 1. Additional analyses will be performed at 50% (133 DFS events), 60% (159 DFS events), and 70% information (186 DFS events), the trial would be stopped for futility if the observed HR were worse than 0.983, 0.971 and 0.959, respectively.
From time of randomization until disease recurrence or death, assessed up to 10 years

Secondary Outcomes (3)

Overall survival (OS)
From time of randomization until death, assessed up to 10 years
Incidence of adverse events (AEs)
From baseline to 10 years after registration
Proportion of patients that tolerate pembrolizumab and tivozanib
From day 1 to 6 months

Other Outcomes (3)

Estimates of treatment effect by sex
Up to 10 years
Estimates of treatment effect by race
Up to 10 years
Estimates of treatment effect by ethnicity
Up to 10 years

Study Arms (2)

Arm 1 (Pembrolizumab)

ACTIVE COMPARATOR

Patients receive pembrolizumab IV on days 1 and 43 of each cycle, or on days 1, 22, 43 and 64 of each cycle. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study.

Biological: PembrolizumabProcedure: Biospecimen CollectionProcedure: MRIProcedure: Computed TomographyProcedure: BiopsyOther: Questionnaire Administration

Arm 2 (pembrolizumab + tivozanib)

EXPERIMENTAL

Patients receive pembrolizumab IV on days 1 and 43 of each cycle and tivozanib PO QD on days 1-21, days 29-49, and days 57-77 of each cycle for up to 6 months. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study.

Biological: PembrolizumabDrug: TivozanibProcedure: Biospecimen CollectionProcedure: MRIProcedure: Computed TomographyProcedure: BiopsyOther: Questionnaire Administration