Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)
This is a single arm phase II study that will evaluate the combination of pembrolizumab, docetaxel, and cisplatin or carboplatin (PDC) as single treatment modality in patients with stage II-IVb (T2-4, any N, M0) squamous cell carcinoma of the nasal cavity/paranasal sinuses (PNS SCC).
⁃ Male/female participants who are at least 18 years of age on the day of signing informed consent with newly diagnosed, previously untreated, histologically and/or cytologically confirmed diagnosis of Stage II-IVb PNS SCC will be enrolled in this study.
⁃ Male participants:
⁃ A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 150 days after the last dose of study treatment and refrain from donating sperm during this period.
• Female participants:
⁃ A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
‣ Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
‣ A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.
• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
∙ Have measurable disease based on RECIST 1.1.
∙ Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
∙ Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Have adequate organ function as defined in the following table (Table 1). Blood must be collected within 14 days prior to the start of study treatment.