Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Running, not enrolling · Phase 2

Conditions studied: 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 Oropharyngeal Squamous Cell Carcinoma, 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 Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Unknown Primary, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVC Hypopharyngeal Carcinoma AJCC v8, Stage IVC Laryngeal Cancer AJCC v8, Stage IVC Lip and Oral Cavity Cancer AJCC v8

In brief

This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.

Key facts

Study ID

NCT04862650

Run by

Marcelo Bonomi

People needed

46

Starts

2021-11-30

Expected to finish

2026-12-31

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recurrent/metastatic (R/M) SCCHN of the oral cavity, oropharynx, larynx and hypopharynx
• No prior systemic therapy for treatment of R/M disease
• Patients with squamous cell carcinoma of an unknown primary are eligible provided their tumor tested positive for p-16 and they have previously received treatment for locoregional head and neck cancer
• Must be at least four weeks since prior radiation and/or surgery
• Must be at least four weeks from curative intent systemic therapy. Of note: patients who have received up to two courses of chemoradiotherapy (CRT) for locoregionally advanced disease are eligible. Induction chemotherapy will not be considered a separate line of therapy
• At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI)
• 18 years of age and older
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• White blood cell (WBC) count > 2,500 cells/uL
• Absolute neutrophil count (ANC) >1,500 cells/uL
• Platelet count >= 100,000 cells/uL
• Hemoglobin >= 9 g/dL
• Creatinine =< 1.6 mg/dL
• Total bilirubin =< 1.6 mg/dL
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]), serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x upper limit of normal (ULN)
• Potassium >= lower limit of normal (LLN)
• Willingness to use medically acceptable contraception throughout the study period and four months after the final administration of treatment
• For female subjects with reproductive potential: a negative serum pregnancy test at baseline
• Ability and willingness to provide written informed consent and to comply with the study visits and assessment schedule

You may not qualify if…

• Disease amenable to curative local therapy
• Nasopharyngeal, salivary gland, lip, or sinonasal carcinoma
• Disease that requires corticosteroids or other ongoing immunosuppressive treatment
• Previous treatment with mAb-based immunotherapy for treatment of prior oncologic treatment
• Previous treatment with PI3K inhibitors
• Known brain metastases, unless stable for at least 21 days prior to registration
• Known infection human immunodeficiency virus (HIV), hepatitis B or C
• Clinically significant cardiac disease (e.g., congestive heart failure, unstable or uncontrolled angina, myocardial infarction) within the past six months
• History of pneumonitis within the past five years
• Recipient of live vaccines (including attenuated) within 30 days of planned study treatment
• Female patients who are pregnant or breast-feeding
• Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements or otherwise compromise the study's objectives in the opinion of the Principal Investigator

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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