NCT03945773

Study of Cabozantinib as 2nd Line Treatment in Subjects With Locally Advanced or Metastatic Renal Cell Carcinoma (RCC) With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors

A Phase II, Multicentre, Open-label Study of Cabozantinib as 2nd Line Treatment in Subjects With Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to evaluate the efficacy and safety of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic RCC with a clear-cell component, who progressed after prior Checkpoint Inhibitors (CPI) therapy with ipilimumab and nivolumab in combination or CPI combined with Vascular Endothelial Growth Factor (VEGF)-targeted therapy.

Conditions

• Locally Advanced or Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib	Oral tablets of 60mg, 40mg and 20 mg.

Timeline

• Start date: 2020-01-08
• Primary completion: 2023-05-11
• Completion: 2026-02-12
• First posted: 2019-05-10
• Last updated: 2026-03-13
• Results posted: 2024-12-19

Locations

40 sites across 7 countries: Austria, France, Germany, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study