Chemotherapy for Advanced Head and Neck Cancer

Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer

Recruiting Phase 2 Interventional Study
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Locally Recurrent Head and Neck Squamous Cell Carcinoma Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma Locally Recurrent Laryngeal Squamous Cell Carcinoma Locally Recurrent Oral Cavity Squamous Cell Carcinoma Locally Recurrent Oropharyngeal Squamous Cell Carcinoma Stage II Laryngeal Cancer AJCC v8 Stage II Lip and Oral Cavity Cancer AJCC v8 Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage III Laryngeal Cancer AJCC v8 Stage III Lip and Oral Cavity Cancer AJCC v8 Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IVA Laryngeal Cancer AJCC v8 Stage IVA Lip and Oral Cavity Cancer AJCC v8 Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IVB Laryngeal Cancer AJCC v8 Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for people with certain types of head and neck cancer that have come back or not gone away after treatment. Participants may receive chemotherapy or a combination of chemotherapy and immunotherapy after surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with locally recurrent or persistent head and neck cancer.
  • I have a PD-L1 score of 1 or higher.
  • I have measurable disease.
  • I am at least 18 years old.
  • I have good physical health, rated 0-2 on ECOG scale.
  • I have an adequate blood count and kidney function.
  • I have not had any cancer treatment in the last 4 weeks.

You may not be able to join if

  • I have distant metastatic disease.
  • I have major vascular involvement that prevents surgery.
  • I have a history of heart disease or heart failure.
  • I have an active infection needing IV treatment.
  • I have severe peripheral neuropathy.
  • I have a history of interstitial lung disease.
  • I have a solid organ transplant other than a corneal transplant.
  • I have had a severe allergic reaction to study drugs.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tiss…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx * PD-L1 combined positive score (CPS) ≥ 1 using a Clinical L…
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