Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases
A Phase II Study of Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases in Patients Previously Treated With Immune Checkpoint Inhibitors
Sponsor: Kelly Fitzgerald, MD + Exelixis
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Proportion of participants who have not progressed at 12 months (PFS12)
Time frame: Up to 12 months
Secondary Endpoints
Percentage of participants with Skeletal Related Events (SRE)
Percentage of participants with osteonecrosis of the jaw (ONJ)
Percentage of participants with reported treatment-related, systemic, adverse events
Eligibility Criteria
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-1 inhibitor/vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitors (TKI). 2. Adjuvant setting; must have received pembrolizumab and have had documented progression of disease within 1 year of the first dose of pembrolizumab . 4. Age ≥18 years. 5. Has seen a dentist within 90 days prior to enrollment and been cleared to receive bone-strengthening agents. 6. Avai…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →