NCT03667482

Cabozantinib in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

A Phase 1 Study of Concurrent Cabozantinib and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of cabozantinib, at different doses, in combination with cetuximab to find out what effects, if any, this combined treatment has on people with HNSCC.

Conditions

• Head and Neck Squamous Cell Cancer
• Recurrent Head and Neck Squamous Cell Cancer
• Metastatic Head and Neck Squamous Cell Cancer

Interventions

Type	Name	Description
DRUG	Cabozantinib	Cabozantinib will be initiated at 40 mg PO daily, with subsequent 20 mg or 40 mg doses as tolerated per the study design.
DRUG	Cetuximab	Cetuximab will be administered at 500 mg/m\^2 intravenously every other week on Days 1 and 15 of each cycle, with a window of up to 3 days before the scheduled date. In an effort to prevent a hypersensitivity reaction, it is recommended that all patients pre-medications, hydration, and anti-emetics will be given according to institutional guidelines and/or per treating physician discretion.

Timeline

• Start date: 2018-09-07
• Primary completion: 2024-07-17
• Completion: 2024-07-17
• First posted: 2018-09-12
• Last updated: 2024-07-23

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study