Trials / Recruiting

RecruitingNCT06589804

Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease

Status: Recruiting
Phase: Phase 3
Study type: Interventional
Enrollment: 158 (estimated)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed 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 evaluate pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1) with respect to duration of response (DOR) per RECIST 1.1. IV. To assess the safety and tolerability of pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1). V. To assess the patient-reported toxicity using Patient Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) of pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1). EXPLORATORY OBJECTIVES: I. To identify specific mutational changes that may be indicative of clinical response to pembrolizumab + cetuximab and pembrolizumab alone. II. To evaluate circulating tumor-derived deoxyribonucleic acid (ctDNA) kinetics over the course of treatment in response to pembrolizumab + cetuximab and pembrolizumab alone. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment. ARM 2: Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1, 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment. After completion of study treatment, patients are followed up within 4 weeks and then every 3 and/or 6 months for up to 5 years.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
BIOLOGICAL	Cetuximab	Given IV
PROCEDURE	Computed Tomography	Undergo CT or PET/CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
BIOLOGICAL	Pembrolizumab	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

Start date: 2025-03-27
Primary completion: 2029-11-30
Completion: 2029-11-30
First posted: 2024-09-19
Last updated: 2026-04-17

Locations

176 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06589804. Inclusion in this directory is not an endorsement.