Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

March 28, 2017

Primary Completion Date

November 19, 2025

Study Completion Date

May 31, 2026

Conditions
HNSCCLip SCCOral Cavity CancerOropharynx CancerLarynx CancerHypopharynx CancerNasopharynx CancerSinonasal CarcinomaCutaneous Squamous Cell CarcinomaHead and Neck NeoplasmsHead and Neck CancerHead and Neck Squamous Cell Carcinoma
Interventions
DRUG

Pembrolizumab, Cetuximab

"Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection.~Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR."

Trial Locations (4)

48109

University of Michigan Cancer Center, Ann Arbor

63110

Washington School of Medicine Cancer Center, St Louis

90095

University of California Los Angeles Cancer Center, Los Angeles

92093

UCSD Moores Cancer Center, La Jolla

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

University of California, San Diego

OTHER