Recruiting

Pembrolizumab with or without Cetuximab for Platinum Refractory Head and Neck Cancer

What is being tested

Biospecimen Collection

+ Computed Tomography

+ Magnetic Resonance Imaging

ProcedureBiological

Who is being recruted

Squamous Cell Carcinoma of Head and Neck+17

+ Carcinoma

+ Carcinoma, Squamous Cell

Over 18 Years

+33 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: March 2025

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)

Last updated: March 25, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 27, 2025

Actual date on which the first participant was enrolled.

This study is exploring treatment options for people with head and neck squamous cell carcinoma that has either come back or spread, and is no longer responding to standard platinum-based chemotherapy. The aim is to determine if combining two drugs, pembrolizumab and cetuximab, can help patients live longer compared to using pembrolizumab alone. This research is important because it could lead to more effective treatments for patients who have limited options once their cancer stops responding to the usual chemotherapy. Participants in the study are split into two groups. One group receives pembrolizumab by IV every 42 days for up to 18 cycles, while the other group receives both pembrolizumab and cetuximab on a similar schedule. Throughout the study, medical imaging tests like CT, PET/CT, or MRI are used to monitor the cancer. Blood samples may also be collected to monitor changes in the disease. The study evaluates how long the treatment keeps the cancer from worsening and checks for side effects. After treatments are completed, patients are followed up regularly for several years to track their progress.

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

NCT06589804

Principal SponsorNational Cancer Institute (NCI)

Last updated: March 25, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

158 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Squamous Cell Carcinoma of Head and NeckCarcinomaCarcinoma, Squamous CellHead and Neck NeoplasmsHypopharyngeal NeoplasmsLaryngeal DiseasesLaryngeal NeoplasmsStomatognathic DiseasesMouth DiseasesMouth NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPharyngeal DiseasesPharyngeal NeoplasmsRespiratory Tract DiseasesRespiratory Tract Neoplasms

Criteria

24 inclusion criteria required to participate

Absolute neutrophil count (ANC) ≥ 1,500/mm^3.

Platelet count ≥ 100,000/mm^3.

Hemoglobin (Hgb) ≥ 9 g/dL (if < 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL).

Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula for participant with creatinine levels > 1.5 x institutional ULN.

Show More Criteria

9 exclusion criteria prevent from participating

Patient must not have received any prior treatment in the recurrent or metastatic setting.

Patient must not have received a live vaccine within 30 days prior to registration.

Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen should be excluded.

Patient must not have a history of any contraindication or have a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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.

Group II

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 175 locations

Recruiting

University of Arkansas for Medical Sciences

Little Rock, United StatesOpen University of Arkansas for Medical Sciences in Google Maps

Recruiting

Fremont - Rideout Cancer Center

Marysville, United States

Recruiting

UCHealth Memorial Hospital Central

Colorado Springs, United States

Recruiting

Memorial Hospital North

Colorado Springs, United States

Recruiting

175 Study Centers