Kelly Fitzgerald, MD
This is a single-institution, phase 2 trial of zanzalintinib plus investigator-choice bone-strengthening agent in patients with metastatic renal cell carcinoma (RCC) with bone metastases whose disease has advanced on 1-3 prior lines of therapy, including at least one immune oncology-based (IO) therapy in the adjuvant or first-line metastatic setting.
PRIMARY OBJECTIVE: I. To evaluate progression-free survival (PFS) at 12 months in participants with RECIST-measurable metastatic RCC and bone metastases at baseline, and who have been previously treated with contemporary IO-based therapy. SECONDARY OBJECTIVES: I. To determine the rate of skeletal-related events (SRE). II. To determine the rate of osteonecrosis of the jaw (ONJ). III. To determine the rate of systemic toxicity. IV. To determine median overall PFS. V. To determine median overall survival (OS) in participants. VI. To evaluate the objective response rate (ORR) in participan…
Inclusion Criteria: 1. Participants must have unresectable advanced or metastatic RCC with a predominant clear cell histologic component . 2. At least three bone metastases are present and detectable on bone scan, and at least one bone metastasis is NOT planned to be treated with radiation therapy. 3. Previously treated with 1-3 prior lines of therapy in at least one of the following settings: 1. Metastatic setting; must have received combination therapy containing either programmed cell death protein 1 (PD-1) inhibitor/cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor or PD-…
Given orally (PO)
One BSA will be chosen, at the discretion of the investigator and given intravenously (IV)
Non-investigational RT is permitted for symptomatic bone metastases.
Undergo Bone Scan
Undergo Imaging
Arctuva estimate
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