The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with cancer.
Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8
Prior therapy: None for NPC permitted
Life expectancy: 3 months at least
Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose.
Prior systemic anticancer treatment for NPC
Prior radiation to head and neck region or regions necessitating overlapping fields
Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
History of allergic reactions to any agents in this study
Single group
Toripalimab
DrugToripalimab will be administered 240 mg intravenously every three weeks in combination with the induction chemotherapy regimen for 3 cycles, and for 9 cycles as adjuvant treatment following radiation as specified in the overall sequential treatment plan.
Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation
RadiationRadiation treatment will be initiated 3-6 weeks following day 1 of the last induction cycle using institutional standards of care and support as follows: Intensity modulated radiotherapy, 70 Gy in 33 fractions M-F once daily plus cisplatin 40 mg/m2 IV weekly for up to 7 doses. Following the completion of concurrent chemoradiation, capecitabine will be administered using institutional standards of care as follows: Capecitabine 650 mg/m2 PO BID x 12 months beginning 12 to 16 weeks following the end of radiation treatment. Dose reductions and discontinuance of capecitabine will be according to the standard of care applied at the treating institution. Adjuvant Toripalimab 240 mg IV q 21d x 9 maximum doses will be initiated concurrently with the initiation of adjuvant capecitabine, beginning 12-16 weeks following the end of radiation.
Induction chemotherapy completion rate
Induction chemotherapy completion rate, defined as the proportion of patients who complete three cycles of chemoimmunotherapy within 12 weeks of initiation. Completion is defined for induction as receiving all 3 cycles as planned, including protocol specified dose reduction and delays. .
Radiation completion rate
Radiation completion rate, defined as the proportion of patients who complete specified radiation within 8 weeks of radiation initiation. Radiation completion is defined as completion of planned doses of radiation.
Overall Response (ORD) rate following induction
OR rate following induction, defined as the proportion of patients who achieve at least a RECIST defined PR within 12 weeks of induction chemotherapy initiation.
Complete Response (CR) rate following radiation
CR rate following radiation, defined as the proportion of patients who achieve a RECIST defined CR within 16 weeks following the end of radiation therapy.
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