The aim of this research study is to evaluate the effectiveness and safety of a combination of immunotherapy, using a drug called toripalimab, with chemotherapy drugs, Carboplatin and Docetaxel, as a possible treatment before surgery for sinonasal cancers.
The names of the study drugs used in this research study are:
* Toripalimab (a type of monoclonal antibody) * Carboplatin (a type of antineoplastic agent) * Docetaxel (a type of antineoplastic agent) * Cisplatin (a type of antineoplastic agent)
Participants must have histologically or cytologically confirmed locoregionally advanced nasal cavity or paranasal sinus cancer including the following histologic subtypes: squamous cell carcinoma (SCC) of any morphologic variation: verrucous, papillary, basaloid, spindle cell, and adenosquamous; or sinonasal undifferentiated carcinoma (SNUC).
Participants with SCC should have resectable disease at baseline per the discretion of the treating surgical oncologist(s). *Participants with SNUC can have operable or borderline resectable (definition: resection would been morbid requiring extensive surgery and would have chances of incomplete gross total resection) disease as judged by the treating surgical oncologist(s).
T2, N1-3 III
T3, any N III, IVA, IVB
Participants with nasal cavity or paranasal sinus malignancies demonstrating histologies other than SCC or SNUC in the opinion of the reviewing pathologist. Excluded subtypes include: angiosarcomas, rhabdomyosarcomas, lymphomas, olfactory neuroblastomas (esthesioneuroblastomas), melanomas, and meningiomas among others. SNEC or sinonasal neuroendocrine carcinoma is not permitted.
Participants with unresectable or inoperable disease as judged by the treating surgical oncologist(s).
Participants with known distant metastatic disease (M1 or IVC).
Has received prior therapy with an anti-PD-1/L1 agent or any other agent directed to another stimulatory or co-inhibitory T-cell receptor.
Sequential
Toripalimab
DrugAn anti-PD-1 monoclonal antibody, single-use vial, via intravenous (into the vein) infusion per protocol.
Carboplatin
DrugAn antineoplastic agent, multi-dose vials, via intravenous (into the vein) infusion per standard of care.
Docetaxel
DrugA taxoid antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.
Radiation Therapy
Radiationper standard of care
Cisplatin
DrugAn antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.
Pathologic Treatment Response Rate (pTRR)
pTRR is defined as the proportion of participants that experience a complete pathologic response or partial pathologic response during treatment, as defined in the RECIST criteria.
Incidence of Adverse Events [Safety and Tolerability]
Safety and tolerability assessed by CTCAE v5.0 and summarized descriptively.
Median Disease-free Survival (DFS)
Disease-free survival (PFS) is defined as the time from the date of study registration to first invasive local, regional, distant recurrence, or death due to any cause. Participants alive without disease are censored at date of last disease evaluation.
Median Overall Survival (OS)
OS is Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.
Organ Preservation Rate
Defined as the percentage of patients with an intact orbit, palate, and skull base immediately post-op from definitive oncologic resection among the study cohort.
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
Coherus Oncology, Inc.
Collaborator