De-Escalation Therapy for Human Papillomavirus Negative Disease (NCT03944915) | Clinical Trial Compass
CompletedPhase 2
De-Escalation Therapy for Human Papillomavirus Negative Disease
United States35 participantsStarted 2019-08-26
Plain-language summary
This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the subject's cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have pathologically confirmed locally advanced, non-metastatic, HPV-negative head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses.
✓. Stage IV disease with the exception of nasopharyngeal tumor-3, node-2 (stage III) based of American Joint Committee on Cancer staging 8th edition
✓. If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry.
✓. Availability of ≥10 unstained 5 micron slides. Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.
✓. Patients must be at least 18 years of age.
✓. Measurable disease (either primary site and/or nodal disease) by RECIST criteria.
✓. No previous radiation or chemotherapy for a head and neck cancer.
✓. No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual measurable disease is acceptable.) No surgical procedures or biopsies will occur after baseline scans are performed and measurable lesions are identified.
Exclusion criteria
✕. Unequivocal demonstration of distant metastatic disease (M1 disease).
✕. Inter-current medical illnesses which would impair patient tolerance to therapy or limit survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance. Patients with clinically stable and/or chronically managed medical illnesses that are not symptomatic and/or are not expected to impact treatment on protocol are still eligible (conditions to be reviewed by the PI to confirm eligibility)
✕. Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.
✕. Patients receiving other investigational agents.
✕. Diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of physiologic dose or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
✕. Known history of active tuberculosis (Bacillus Tuberculosis infection).
✕. Hypersensitivity to nivolumab or any other drug used in this protocol.