Immunotherapy-Chemo cocktail shows promise for tough head and neck cancers

NCT ID NCT04862650

First seen Feb 15, 2026 · Last updated Jun 23, 2026 · Updated 20 times

Summary

This phase II trial is testing whether combining the immunotherapy drug cemiplimab with low doses of two chemotherapy drugs (paclitaxel and carboplatin) can shrink tumors in people with head and neck cancer that has come back or spread. The study includes 46 participants who have not had prior systemic therapy for their advanced disease. The main goal is to see how many patients respond to treatment after 12 weeks.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

cemiplimab (immunotherapy) plus paclitaxel and carboplatin (chemotherapy)

What this could lead to

If successful, this combination could offer a new treatment option for people with advanced head and neck cancer that has returned or spread.

What could go wrong

This is a small, early-phase trial (46 people) with no control group, so results may not apply broadly. Side effects from chemo and immunotherapy can be serious.

Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma hypopharynx cancer hypopharynx squamous cell carcinoma laryngeal neoplasm laryngeal squamous cell carcinoma lip and oral cavity squamous cell carcinoma Mouth Neoplasms oral cavity squamous cell carcinoma oropharynx cancer oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CLINICAL STAGE IV HPV-MEDIATED (P16-POSITIVE) OROPHARYNGEAL CARCINOMA AJCC V8 CLINICAL STAGE IV HPV-MEDIATED (P16-POSITIVE) OROPHARYNGEAL CARCINOMA AJCC V8 METASTATIC HEAD-AND-NECK SQUAMOUS-CELL CARCINOMA METASTATIC HYPOPHARYNGEAL SQUAMOUS CELL CARCINOMA METASTATIC LARYNGEAL SQUAMOUS CELL CARCINOMA METASTATIC ORAL CAVITY SQUAMOUS CELL CARCINOMA METASTATIC ORAL CAVITY SQUAMOUS CELL CARCINOMA METASTATIC OROPHARYNGEAL SQUAMOUS CELL CARCINOMA PATHOLOGIC STAGE IV HPV-MEDIATED (P16-POSITIVE) OROPHARYNGEAL CARCINOMA AJCC V8 PATHOLOGIC STAGE IV HPV-MEDIATED (P16-POSITIVE) OROPHARYNGEAL CARCINOMA AJCC V8 RECURRENT HEAD AND NECK SQUAMOUS CELL CARCINOMA RECURRENT HYPOPHARYNGEAL SQUAMOUS CELL CARCINOMA RECURRENT LARYNGEAL SQUAMOUS CELL CARCINOMA RECURRENT ORAL CAVITY SQUAMOUS CELL CARCINOMA RECURRENT ORAL CAVITY SQUAMOUS CELL CARCINOMA RECURRENT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA RECURRENT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA SQUAMOUS CELL CARCINOMA OF UNKNOWN PRIMARY STAGE IV HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IV HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IV LARYNGEAL CANCER AJCC V8 STAGE IV LARYNGEAL CANCER AJCC V8 STAGE IV LIP AND ORAL CAVITY CANCER AJCC V8 STAGE IV LIP AND ORAL CAVITY CANCER AJCC V8 STAGE IVA HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IVA HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IVA LARYNGEAL CANCER AJCC V8 STAGE IVA LARYNGEAL CANCER AJCC V8 STAGE IVA LIP AND ORAL CAVITY CANCER AJCC V8 STAGE IVA LIP AND ORAL CAVITY CANCER AJCC V8 STAGE IVB HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IVB HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IVB LARYNGEAL CANCER AJCC V8 STAGE IVB LARYNGEAL CANCER AJCC V8 STAGE IVB LIP AND ORAL CAVITY CANCER AJCC V8 STAGE IVB LIP AND ORAL CAVITY CANCER AJCC V8 STAGE IVC HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IVC HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IVC LARYNGEAL CANCER AJCC V8 STAGE IVC LARYNGEAL CANCER AJCC V8 STAGE IVC LIP AND ORAL CAVITY CANCER AJCC V8 STAGE IVC LIP AND ORAL CAVITY CANCER AJCC V8