Perioperative Chemoimmunotherapy With Toripalimab for Sinonasal Cancer
Glenn J. Hanna
Summary
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)
Description
This single-arm, open-label, single-center phase II 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. Toripalimab binds to the PD-1 receptors on T-cells (immune cells) and prevents them from interacting with PD-L1 and PD-L2 on tumor cells. This stimulates the immune system to fight tumor cells. The U.S. Food and Drug Administration (FDA) has not approved Toripalimab for sinonasal cancers, but it has been approved…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 mor…
Interventions
- DrugToripalimab
An anti-PD-1 monoclonal antibody, single-use vial, via intravenous (into the vein) infusion per protocol.
- DrugCarboplatin
An antineoplastic agent, multi-dose vials, via intravenous (into the vein) infusion per standard of care.
- DrugDocetaxel
A taxoid antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.
- RadiationRadiation Therapy
per standard of care
- DrugCisplatin
An antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts