A Phase II Study of Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases in Patients Previously Treated With Immune Checkpoint Inhibitors
Kelly Fitzgerald, MD
Summary
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.
Description
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…
Eligibility
- Age range