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

Head and Neck Cancer Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03646461
Study type Interventional
Source University of California, San Diego
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 17, 2018
Completion date May 30, 2025
View Details
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