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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

ConditionsMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Neck Squamous Cell Carcinoma of Unknown PrimaryRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRefractory Head and Neck Squamous Cell CarcinomaRefractory Hypopharyngeal Squamous Cell CarcinomaRefractory Laryngeal Squamous Cell CarcinomaRefractory Oral Cavity Squamous Cell CarcinomaRefractory Oropharyngeal Squamous Cell CarcinomaStage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Cetuximab

    Biological/Vaccine

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: Arm 1 (pembrolizumab)Active comparator 5 interventions
Group B: Arm 2 (cetuximab, pembrolizumab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Will be estimated using the Kaplan-Meier method. Will be based on the stratified log-rank test that will compare the distributions across the treatment arms. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well, where the multivariable Cox model will also adjust for other key baseline factors of interest. Hazard ratios and 95% confidence intervals, along with likelihood ratio p-values will be reported from these Cox models. Forest plots will be used to illustrate the comparisons between the arms within subgroups defined by stratification factors and key baseline characteristics.

Time frame
Time from randomization to death from any cause, assessed up to 5 years

Secondary outcomes

1

Confirmed response rate

Will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria if patients have a partial or complete response for 2 consecutive evaluations at least 4 weeks apart, using local review only. The proportion of patients with a confirmed response will be calculated and compared between the 2 arms using a Chi-square or Fisher's Exact test.

Time frame
Up to 5 years
2

Duration of response

Will be defined for all evaluable patients who have achieved an objective response. Will be assessed per RECIST 1.1 criteria. Will be estimated using the Kaplan-Meier method.

Time frame
From the date at which the patient's earliest best objective status is first noted to be either a complete response or partial response to the earliest date progression is documented, assessed up to 5 years
3

Progression free survival

Disease progression will be assessed per RECIST 1.1 criteria. Will be compared between the 2 arms using the Kaplan-Meier method, where the log-rank test will be used to calculate the p-value.

Time frame
Time from randomization to the first of either disease progression or death from any cause, assessed up to 5 years
4

Incidence of adverse events

Will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.

Time frame
Up to 5 years

Other outcomes

1

Estimates of median OS by sex

Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by sex.

Time frame
Up to 5 years
2

Estimates of median OS by race

Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by race.

Time frame
Up to 5 years
3

Estimates of median OS by ethnicity

Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by ethnicity.

Time frame
Up to 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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