Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to
evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients
with recurrent/metastatic HNSCC. There will be four patient cohorts, including a PD-1/PD-L1
inhibitor-naïve, cetuximab-naïve arm (Cohort 1), a PD-1/PD-L1 inhibitor-refractory,
cetuximab-naïve arm (Cohort 2), a PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory arm
(Cohort 3), and a cutaneous HNSCC arm (Cohort 4). A total of 83 patients (33 in Cohort 1, 25
in Cohort 2, 15 in Cohort 3, and 10 in Cohort 4) will be eligible to enroll. Patients will be
enrolled at 4 sites: UC San Diego Moores Cancer Center, UC Los Angeles Jonsson Comprehensive
Cancer Center, University of Michigan Comprehensive Cancer Center, and University of
Washington Siteman Cancer Center.