A Pilot, Rapid Sequencing of First Line Cabozantinib, Ipilimumab and Nivolumab, and Lenvatinib and Everolimus in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma

Summary

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 \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).

Description

Eligibility

Age range

18–99 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Cabozantinib

  60mg oral once daily for 12 weeks

• Drug
  Ipilimumab

  1mg/kg intravenous once every 3 weeks over 12 weeks

• Drug
  Nivolumab

  3mg/kg intravenous once every 3 weeks over 12 weeks, then 480mg once every 4 weeks after

• Drug
  Lenvatinib

  18mg oral once daily for 12 weeks

• Drug
  Everolimus

  5mg oral once daily for 12 weeks

Location