SAFETY EVALUATIONS OF NIVOLUMAB (ANTI-PD-1) ADDED TO CHEMORADIOTHERAPY (CRT) PLATFORMS IN PATIENTS WITH INTERMEDIATE AND HIGH-RISK LOCAL-REGIONALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA
Clinical Trial Information
Trial Contact: Jarquin-Castillo, Katherine ; Quintiliani, Jennifer
IRB No: 16.114.09
Protocol Abbrev: RTOG 3504
Principal Investigator: Justin Mathew Rineer, MD
Sub Investigators: Tseng, Jennifer MD; Johnson, Tirrell MD; Neely, Lindsey ARNP
Phase: Drug: Phase I
Age Group: Adult
Secondary Protocol No: RTOG 3504
Applicable Disease Sites: Head and Neck
Therapies Involved: Nivolumab, Cisplatin and Cetuximab
ClinicalTrials.gov ID: NCT02764593
Primary Objective: To evaluate the safety of the addition of nivolumab to several chemotherapy
platforms with weekly cisplatin, high-dose cisplatin, cetuximab or radiation therapy alone.
Secondary Objective: To evaluate the safety, feasibility and patient compliance with adjuvant
administration of single agent nivolumab to a maximum of 1 year of therapy.
Histologically or cytologically-confirmed diagnosis of HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx; A histological or pathological specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable;
Intermediate-risk Group: Oropharynx cancer that is p16-positive by immunohistochemistry with smoking status
> 10 Pack-years, stage T2 N2b-N3 or T3-4 N0-3 OR
≤ 10 pack-years, stage T4N0-N3 or T2-T3N2c-N3;
High-risk Group: Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer, stage T2 N2a-N3 or T3-4 N0-3 based on the following diagnostic workup:
Mandatory submission of H&E and p16 stained slides and (or punch biopsy of paraffin block) to the Biospecimen Bank at UCSF for central review of p16 staining is required for oropharyngeal patients and for PD-L1 expression analysis for all patients; see Section 10 for details.
History/physical examination within 28 days prior to registration;
Examination by Radiation Oncologist, Medical Oncologist, and ENT or Head & Neck Surgeon within 28 days prior to registration;
Fiberoptic exam with laryngopharyngoscopy within 28 days prior to registration;
Diagnostic quality, cross sectional imaging of the thorax within 28 days prior to registration; 18-F-FDG-PET/CT or conventional CT are acceptable. See “Recommendations for Imaging” in Section 4 for guidance.
RTOG 3504 23 Version Date: 5/19/16
Diagnostic quality CT or MRI of neck, with contrast, within 28 days prior to registration; a 18-F-FDG-PET/CT of the neck only is acceptable as a substitute if the CT is of diagnostic quality and with IV contrast