drugset / Trial / NCT05188118

Rapid Sequencing of Approved Therapies in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma

NCT05188118

Phase 0 Recruiting 20 enrolled Icahn School of Medicine at Mount Sinai
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2023-02-15
Primary completion
2026-09
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabozantinib Small molecule 60 mg Oral
Subject Everolimus Small molecule 5 mg Oral
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Lenvatinib Small molecule 18 mg Oral
Subject Nivolumab Monoclonal antibody 480 mg Intravenous

Indications