Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE
Alliance for Clinical Trials in Oncology
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.
Description
PRIMARY OBJECTIVE: I. To compare disease free survival (DFS) as assessed by the investigator for high-risk renal cell carcinoma patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone. SECONDARY OBJECTIVES: I. To compare overall survival (OS) for patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone. II. To assess adverse events in each study arm by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. BIOBANKING OBJECTIVE: I. To bank specimens for future unspecified research. QUALITY OF…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy) * Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted * Intermediate-high risk RCC: * pT2 grade 4 or sarcomatoid features, N0M0 * pT3 any grade N0, M0 * High-risk RCC * pT4, any grade, N0, M0 * pT, any stage., any grade, N+, M0 * cM1 no evidence of disease (NED) RCC *…
Interventions
- BiologicalPembrolizumab
Given intravenously
- DrugTivozanib
Given orally
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureMRI
Undergo MRI
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureBiopsy
Undergo biopsy
- OtherQuestionnaire Administration
Ancillary studies
Locations (410)
- Cancer Center at Saint Joseph'sPhoenix, Arizona
- Banner University Medical Center - TucsonTucson, Arizona
- University of Arizona Cancer Center-North CampusTucson, Arizona
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, Arkansas
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Sutter Auburn Faith HospitalAuburn, California