Icahn School of Medicine at Mount Sinai
This is a pilot, single-center, single-arm study where 20 patients with metastatic or unresectable clear cell renal cell carcinoma will receive same sequential treatment strategy (Cabozantinib for 12 weeks, then proceed with Ipilimumab plus Nivolumab immunotherapy x4 over 12 weeks, then subsequent therapies depending on treatment response for another 12 weeks \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).
Multi-targeted tyrosine kinase inhibitors (TKI) and immune checkpoint inhibitors represent two systemic modalities that has improved outcomes in patient with metastatic clear cell renal cell carcinoma (ccRCC). However, as an increasing number of treatment approaches has been sequentially approved in the front line setting, the optimal treatment selection and sequence have yet to be clearly defined. First line combination immunotherapy with nivolumab (PD-1 inhibitor) plus ipilimumab (CTLA-4 Inhibitor) has demonstrated improved overall survival and patient quality of life compared to Sunitinib…
Inclusion Criteria: * Age ≥ 18 years at the time of study entry * Capable of understanding and complying with the protocol requirements and must have signed the informed consent document * ECOG performance status of 0 or 1 or KPS of at least 80% * Life expectancy ≥ 12 weeks * Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (stage IV) RCC with predominantly clear cell component (sarcomatoid differentiation \<50%) a. Patients with localized RCC who develop metastatic disease post definitive nephrectomy, with or without systemic therapy…
60mg oral once daily for 12 weeks
1mg/kg intravenous once every 3 weeks over 12 weeks
3mg/kg intravenous once every 3 weeks over 12 weeks, then 480mg once every 4 weeks after
18mg oral once daily for 12 weeks
5mg oral once daily for 12 weeks
Arctuva estimate
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