Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Recurrence

Mouth Neoplasms

Laryngeal Neoplasms

Oropharyngeal Neoplasms

Lip Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Otorhinolaryngologic Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Pharyngeal Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cemiplimab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Patients will be treated with a combination of cemiplimab 350 mg every three weeks, with weekly combination of paclitaxel 25 mg/m2 and carboplatin AUC 1. Treatment will continue for a total of 24 months or until disease progression or unacceptable toxicity. Weekly chemotherapy will stop after six months of treatment (24 weeks). A ten patient safety run-in phase will be initially performed.

The Ohio State University Comprehensive Cancer Center

Marcelo R. Bonomi, MD

Marcelo R Bonomi, MD

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.

PRIMARY OBJECTIVE:

I. To assess the overall response rate (ORR) at 12 weeks of treatment with the treatment combination cemiplimab, paclitaxel, and carboplatin.

SECONDARY OBJECTIVES:

I. To assess toxicity/tolerance to the proposed treatment combination (a safety run-in phase of ten patients will be performed initially).

II. To assess progression-free survival (PFS) and overall survival (OS) at one and two years.

EXPLORATORY OBJECTIVES:

I. Prospectively test the ability of our clinical nomogram to predict median OS in squamous cell carcinoma of the head and neck (SCCHN) patients planning to receive first-line cemiplimab in combination with low-dose weekly paclitaxel and carboplatin. II. To assess the PFS and OS of patients with combined positive score (CPS) \<1%, \>1%, and \> 20%.

III. Compare the predictive power of our nomogram to that of CPS in the prospective cohort, as well as evaluate the combined correlation of nomogram and CPS to median OS.

IV. Perform comprehensive immune analysis including phenotypic analysis of immune cell subsets using high dimensional spectral flow cytometry. T cell functionality and ability to produce cytokines after ex vivo stimulation for all T cells and E6/E7-reactive T cells (P16+ subset patients) and TCR sequencing to determine if clonal T cell populations emerge from the tumor of responding patients in comparison with non-responders.

OUTLINE:

Patients receive cemiplimab intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 104 weeks, and paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes once weekly (QW) for up to 24 weeks. Treatment continuous in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 14 days and then every 12 weeks.

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

A Phase II Trial of the Efficacy and Safety of the Combination of Cemiplimab and Low-Dose Paclitaxel and Carboplatin in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

ORR defined as the proportion of patients with a documented complete response (CR) + partial response (PR) at week 12 of treatment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. An ORR of 40% (percent) or higher will be consider a positive result. Simon two-stage optimal design will be used.

PFS will be calculated based on RECIST criteria.

Toxicity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Marcelo Bonomi

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck	NCT04862650	Clinical Stage ... Metastatic Head... Metastatic Hypo... Metastatic Lary... Metastatic Oral... Metastatic Orop... Pathologic Stag... Recurrent Head ... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph... Squamous Cell C... Stage IV Hypoph... Stage IV Laryng... Stage IV Lip an... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Lip a... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Lip a... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Lip a...	Carboplatin Cemiplimab Paclitaxel	18 Years -	Ohio State University Comprehensive Cancer Center
Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck	NCT04862650	Clinical Stage ... Metastatic Head... Metastatic Hypo... Metastatic Lary... Metastatic Oral... Metastatic Orop... Pathologic Stag... Recurrent Head ... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph... Squamous Cell C... Stage IV Hypoph... Stage IV Laryng... Stage IV Lip an... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Lip a... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Lip a... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Lip a...	Carboplatin Cemiplimab Paclitaxel	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for stage ivc lip and oral cavity cancer ajcc v8