RECRUITING

Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer

Conditions

Head and Neck Squamous Cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma Metastatic Head-and-neck Squamous-cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.

Official Title

Pilot Phase II Study to Evaluate Effect of Cetuximab Given as Single Agent After Immunotherapy With PD-1 Inhibitors in Patients With Head and Neck Squamous Cell Carcinoma

Quick Facts

Study Start:2020-07-01

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04375384

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma. * Measurable disease by scans- at least one measurable lesion. * Patients must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy. * Patients must have a Performance Status of 0-2. * Patients must be greater than or equal to 18 years old. * Willing to provide consent for collection of samples of blood and saliva as scheduled through the treatment. * Subject is willing and able to comply with the protocol for the duration of the study. * Willingness to donate 2 tablespoons of blood and one teaspoon of saliva for research before treatment, 3 more times during the first 5 weeks of treatment and then at cancer progression. * Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.	* Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway. * Prior allergic reaction to Cetuximab. * History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of Cetuximab. * Patients receiving any other investigational agents. * Patient is on medications that need to be continued and that might interact with Cetuximab. * Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study treatment and procedures. * Subject with a history of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest imaging. * Serious or non-healing wound, ulcer, or bone fracture at the discretion of treating physician * history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment * history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study enrollment * history of myocardial infarction, ventricular arrhythmia, stable/unstable angina, -symptomatic congestive heart failure, coronary/peripheral artery bypass graft or stenting or other significant cardiac disease within 6 months prior to study enrollment * history of arterial or venous thrombosis/thromboembolic event, including pulmonary embolism within 6 months of study enrollment * any condition requiring the use of immunosuppression, excluding rheumatologic conditions treated with stable doses of corticosteroids.

Inclusion Criteria

Exclusion Criteria

* Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma.
* Measurable disease by scans- at least one measurable lesion.
* Patients must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy.
* Patients must have a Performance Status of 0-2.
* Patients must be greater than or equal to 18 years old.
* Willing to provide consent for collection of samples of blood and saliva as scheduled through the treatment.
* Subject is willing and able to comply with the protocol for the duration of the study.
* Willingness to donate 2 tablespoons of blood and one teaspoon of saliva for research before treatment, 3 more times during the first 5 weeks of treatment and then at cancer progression.
* Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.

* Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway.
* Prior allergic reaction to Cetuximab.
* History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of Cetuximab.
* Patients receiving any other investigational agents.
* Patient is on medications that need to be continued and that might interact with Cetuximab.
* Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study treatment and procedures.
* Subject with a history of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest imaging.
* Serious or non-healing wound, ulcer, or bone fracture at the discretion of treating physician
* history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment
* history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study enrollment
* history of myocardial infarction, ventricular arrhythmia, stable/unstable angina, -symptomatic congestive heart failure, coronary/peripheral artery bypass graft or stenting or other significant cardiac disease within 6 months prior to study enrollment
* history of arterial or venous thrombosis/thromboembolic event, including pulmonary embolism within 6 months of study enrollment
* any condition requiring the use of immunosuppression, excluding rheumatologic conditions treated with stable doses of corticosteroids.

Contacts and Locations

Study Contact

Study Nurse

CONTACT

336-713-7748

saverill@wakehealth.edu

Principal Investigator

Mercedes Porosnicu, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Mercedes Porosnicu, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-01

Study Completion Date2025-12

Study Record Updates

Study Start Date2020-07-01

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Metastatic Head-and-neck Squamous-cell Carcinoma