Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease
National Cancer Institute (NCI)
Summary
This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.
Description
PRIMARY OBJECTIVE: I. To assess whether the combination of cetuximab and pembrolizumab (arm 2) compared to pembrolizumab alone (arm 1) results in improved overall survival (OS) in subjects with platinum refractory HNSCC. SECONDARY OBJECTIVES: I. To compare pembrolizumab + cetuximab (arm 2) versus (vs.) pembrolizumab alone (arm 1) with respect to objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. II. To compare pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1) with respect to progression free survival (PFS) per RECIST 1.1. III. To evaluat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC). * Previously untreated for recurrent and/or metastatic disease incurable by local therapies. * Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx. * Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair. * Measurable disease. * Must have platinum-refractory disease defined as disease progressi…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- BiologicalCetuximab
Given IV
- ProcedureComputed Tomography
Undergo CT or PET/CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- BiologicalPembrolizumab
Given IV
- ProcedurePositron Emission Tomography
Undergo PET/CT
Locations (177)
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Fremont - Rideout Cancer CenterMarysville, California
- VA Palo Alto Health Care SystemPalo Alto, California
- UCHealth Memorial Hospital CentralColorado Springs, Colorado
- Memorial Hospital NorthColorado Springs, Colorado
- Poudre Valley HospitalFort Collins, Colorado