Actively Recruiting
Toripalimab With Chemotherapy for Sinus Cancer
Led by Glenn J. Hanna · Updated on 2025-06-26
20
Participants Needed
2
Research Sites
189 weeks
Total Duration
On this page
Sponsors
G
Glenn J. Hanna
Lead Sponsor
C
Coherus Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Toripalimab With Chemotherapy for Sinus Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locoregionally advanced nasal cavity or paranasal sinus cancer including squamous cell carcinoma (any morphologic variation) or sinonasal undifferentiated carcinoma
- Resectable disease for squamous cell carcinoma or operable/borderline resectable disease for sinonasal undifferentiated carcinoma as judged by the surgical oncologist
- Clinical stage disease T2, N1-3 III; T3, any N III, IVA, IVB; or T4, any N IVA, IVB according to the 8th edition TNM staging system
- Willingness to provide blood and tissue samples before treatment and at surgery for analysis
- Age 18 years or older at informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function as defined by specific blood counts and kidney/liver function
- Agreement to use effective contraception during the study and specified periods after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Malignancies other than squamous cell carcinoma or sinonasal undifferentiated carcinoma (e.g., angiosarcomas, rhabdomyosarcomas, lymphomas, olfactory neuroblastomas, melanomas, meningiomas, sinonasal neuroendocrine carcinoma)
- Unresectable or inoperable disease as judged by the surgical oncologist
- Known distant metastatic disease
- Prior therapy with anti-PD-1/L1 or other T-cell receptor-directed agents
- Receipt of live or live-attenuated vaccine within 30 days before first study drug dose
- Immunodeficiency or ongoing systemic corticosteroid/immunosuppressive therapy exceeding specified doses
- Active malignancy progressing or requiring treatment within past 2 years (with exceptions)
- Active autoimmune disease requiring systemic treatment within past 6 months
- History or current pneumonitis or interstitial lung disease needing steroids
- Uncontrolled HIV infection; well-controlled HIV allowed with criteria
- Active Hepatitis B or C infection
- History of allogeneic tissue or solid organ transplant
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
G
Glenn J Hanna, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here