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

Musculoskeletal Diseases

Paranasal Sinus Neoplasms

Nose Neoplasms

Nose Diseases

Paranasal Sinus Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Pyrazole

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients receive celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.

Patients receive placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.

Placebo

Quality-of-Life Assessment

Questionnaire Administration

Richard Cannon, MD

This phase II trial studies how well celecoxib works through surgery and radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced). Celecoxib is Food and Drug Administration approved to treat arthritis, acute pain, and painful menstrual periods. Adding celecoxib to standard of care treatment may help to decrease the amount of time between surgery and radiation therapy.

PRIMARY OBJECTIVE:

I. To assess the number of days from surgery to initiation of radiation with the addition of celecoxib compared to placebo.

SECONDARY OBJECTIVES:

I. To assess overall pain control and management for patients on celecoxib compared to placebo.

II. To assess functional outcomes for patients on celecoxib compared to placebo.

III. To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo.

IV. To assess the average number of treatment days missed during adjuvant radiation for patients on celecoxib compared to placebo.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive celecoxib orally (PO) or via feeding tube twice daily (BID) starting 5 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO or via feeding tube BID starting 5 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.

Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

RESILIENCE: Effect of Comprehensive Celecoxib Through Treatment for Advanced-Stage Head and Neck Cancer: A Randomized, Double-Blinded, Placebo-Controlled Trial

The day of surgery will be considered day 0 and the number of days will be counted until the first dose of adjuvant radiation. A Gaussian mixed effects regression model will be used to compare the average number of days from surgery to the initiation of radiation and adjuvant therapy between treatment and control groups. The model will contain fixed effects for treatment arm and provider and a nested random effect for patient within provider. The mean difference between treatment groups, two-sided p-value and 95% confidence interval will be calculated from the model.

Assessment of subjective pain scores on the visual analog scale of pain intensity averaged over a week at rest, with a swallow, and with a cough. Pain intensity scale is a range from 0-10. 0= No Pain, 5= Moderate pain, 10= Unbearable paining

Assessment of current activity level and swallowing capabilities, including food and liquid variety and assessment of G tube utilization.

Completion of quality of life questionnaire EORTC QLQ-H\&N43 as per the protocol described schedule.

Assess the number of treatment days missed or delayed during adjuvant radiation.

Narcotic consumption will be assessed in daily total morphine equivalents averaged over a week

Patient satisfaction will be assessed with pain control questionnaire.

Completion of quality of life questionnaire MDASI-HN as per the protocol described schedule.

National Cancer Institute (NCI)

University of Utah

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer	NCT04162873	Clinical Stage ... Clinical Stage ... Nasal Cavity an... Oral Cavity Car... Pathologic Stag... Pathologic Stag... Recurrent Hypop... Recurrent Laryn... Recurrent Nasal... Recurrent Oral ... Recurrent Oroph... Stage III Hypop... Stage III Laryn... Stage III Oroph... Stage IV Hypoph... Stage IV Laryng... Stage IV Oropha... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Oroph... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Oroph... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Oroph...	Celecoxib Placebo Quality-of-Life... Questionnaire A...	18 Years -	University of Utah
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 hypopharyngeal carcinoma ajcc v8