Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer (NCT03383094) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer
United States126 participantsStarted 2018-03-15
Plain-language summary
The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* p16-positive squamous cell carcinoma of the pharynx, larynx or oral cavity
* High-Intermediate Risk Disease, defined as:
* T1-T3 N2 M0 or T3 N1 M0 or any stage III (T4 or N3) p16+ squamous cell carcinoma of the oropharynx (AJCC 8th edition staging system)
* T1-2 N1-3 M0 or T3-4 N0-3 M0 (stage III-IVB) p16+ squamous cell carcinoma of the hypopharynx or larynx
* T1-2 N2-3 M0 or T3-4 N0-3 M0 (stage III-IVB) p16+ squamous cell carcinoma of the nasopharynx
* Inoperable T4 N0-3 M0 (stage IVA-IVB) p16+ squamous cell carcinoma of the oral cavity
* Measurable disease based on RECIST 1.1
* Adequate hematologic function within 28 days prior to registration
* Adequate renal and hepatic function
* Female subject of childbearing potential should have a negative pregnancy test
* Female subjects of childbearing potential must agree to use an adequate method of contraception for the course of the study
* Male subjects must agree to use an adequate method of contraception for the course of the study
Exclusion Criteria:
* Prior malignancy within the past 3 years (except non-melanomatous skin cancer and early stage treated prostate cancer);
* Prior head and neck radiation, chemotherapy, or immunotherapy;
* Prior oncologic (radical) surgery to the primary site;
* Documented evidence of distant metastases;
* Severe, active co-morbidity defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
* T…