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

Conditions

• Metastatic Head and Neck Squamous Cell Carcinoma
• Metastatic Hypopharyngeal Squamous Cell Carcinoma
• Metastatic Laryngeal Squamous Cell Carcinoma
• Metastatic Oral Cavity Squamous Cell Carcinoma
• Metastatic Oropharyngeal Squamous Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma
• Recurrent Hypopharyngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Squamous Cell Carcinoma
• Recurrent Neck Squamous Cell Carcinoma of Unknown Primary
• Recurrent Oral Cavity Squamous Cell Carcinoma
• Recurrent Oropharyngeal Squamous Cell Carcinoma
• Refractory Head and Neck Squamous Cell Carcinoma
• Refractory Hypopharyngeal Squamous Cell Carcinoma
• Refractory Laryngeal Squamous Cell Carcinoma
• Refractory Oral Cavity Squamous Cell Carcinoma
• Refractory Oropharyngeal Squamous Cell Carcinoma
• Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
• Stage IV Hypopharyngeal Carcinoma AJCC v8
• Stage IV Laryngeal Cancer AJCC v8
• Stage IV Lip and Oral Cavity Cancer AJCC v8
• Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Mar 27, 2025

Status verified

Mar 2026

Primary completion

Nov 30, 2029

Completion

Nov 30, 2029

Study Design

Enrollment

158 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1 (pembrolizumab)
  Patients receive 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.
• Experimental: Arm 2 (cetuximab, pembrolizumab)
  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.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Time from randomization to death from any cause, assessed up to 5 years ]

Locations (177)

Find similar trials in Little Rock, AR

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