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

A032201: Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE

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Renal cell carcinoma
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Overview
Principal Investigator: Paul Matthew, MD

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.

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Latoya Marshall

Study details
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).
  • Hematemesis, hematochezia or other gastrointestinal bleeding grade 3 or higher
  • Hemoptysis of pulmonary bleeding grade 3 or higher
Exclusion Criteria
  • History of myocarditis
  • History of clinically significant pneumonitis
  • Uncontrolled hypertension (systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg) documented on 2 consecutive measurements taken at least 2 hours apart.
Study Requirements

Active Comparator: Arm 1 (Pembrolizumab)
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.
Interventions:
Biological: Pembrolizumab
Procedure: Biospecimen Collection
Procedure: MRI
Procedure: Computed Tomography
Procedure: Biopsy
Other: Questionnaire Administration
Experimental: Arm 2 (pembrolizumab + tivozanib)
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.
Interventions:
Biological: Pembrolizumab
Drug: Tivozanib
Procedure: Biospecimen Collection
Procedure: MRI
Procedure: Computed Tomography
Procedure: Biopsy
Other: Questionnaire Administration