NCT03646461

Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC

A Multi-Institutional, Open-Label, Randomized, Phase II Trial Of Ibrutinib In Combination With EGFR Inhibition Or PD-1 Inhibition In Patients With Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, phase II trial to test the efficacy of Ibrutinib in combination with either Nivolumab or Cetuximab in the treatment of recurrent and/or metastatic head an neck squamous cell carcinoma

Detailed description

Open-label, randomized, controlled, clinical trial. Enrollment will be stratified by HPV status and randomized in a 1:1 ratio to either ibrutinib + cetuximab or ibrutinib + nivolumab The study will enroll patients who develop R/M HNSCC have not yet been treated with EGFR inhibitors in the recurrent/metastatic setting. All patients being considered for the study must be ≥ 18 years of age and will receive: i) ibrutinib + cetuximab or ii) ibrutinib + nivolumab. To determine the clinical efficacy of ibrutinib in combination with cetuximab or nivolumab in patients with R/M HNSCC. Ibrutinib will be supplied by Pharmacyclics as 140 mg hard gelatin capsules for oral (PO) administration. Cetuximab will be supplied as a clear, colorless liquid formulated for intravenous administration. Nivolumab will be supplied as a clear, colorless liquid formulated for intravenous administration.

Conditions

• Head and Neck Cancer
• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Ibrutinib 560mg PO daily (Imbruvica)	BTK inhibitor combined with PD-1 inhibitor
DRUG	Cetuximab	Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
DRUG	Nivolumab	Nivolumab 3mg/kg biweekly 28 day cycle

Timeline

• Start date: 2018-10-17
• Primary completion: 2025-12-11
• Completion: 2025-12-30
• First posted: 2018-08-24
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study