This phase II trial tests the effect of toripalimab in combination with carboplatin and docetaxel before surgery (neoadjuvant) in treating patients with stage III-IVB sinonasal cancer. Immunotherapy with monoclonal antibodies, such as toripalimab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Giving neoadjuvant toripalimab with carboplatin and docetaxel may help optimize surgical planning with the hope to improve the chances of preserving surrounding organs such as the orbit (eye socket), palate (roof of mouth) and skull base (bone that supports the brain where other close body parts connect to the brain).
Additional locations may be listed on ClinicalTrials.gov for NCT06940180.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Glenn J. Hanna
Phone: 617-632-3090
Dana-Farber Cancer InstituteStatus: Active
Contact: Glenn J. Hanna
Phone: 617-632-3090
PRIMARY OBJECTIVE:
I. To evaluate the pathologic treatment response (pTR) rate to pre-operative (pre-op) neoadjuvant chemoimmunotherapy.
SECONDARY OBJECTIVES:
I. To evaluate safety and tolerability of neoadjuvant therapy.
II. To estimate disease-free survival (DFS) including rates of local, regional, and/or distant disease control.
III. To estimate overall survival (OS).
IV. To evaluate organ preservation rate (intact orbit, palate, and skull base).
V. To estimate the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 to pre-operative chemoimmunotherapy prior to surgery.
VI. To evaluate the association of tumor PD-L1 combined positive score (CPS) with pTR and survival outcomes.
EXPLORATORY OBJECTIVES:
I. To evaluate changes in tumor and blood immune profiling parameters and their association with response and outcomes.
II. To evaluate patient reported quality of life (PRQoL) using the Sino-Nasal Outcome Test (SNOT)-22 questionnaire results.
OUTLINE:
NEOADJUVANT CHEMOIMMUNOTHERAPY: Patients receive toripalimab intravenously (IV) over 30-60 minutes, carboplatin IV over 30 minutes, and docetaxel IV on day 1 of each cycle. Cycles repeat every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within 35-50 days of cycle 1, day 1, patients undergo surgery (patients with sinonasal undifferentiated carcinoma [SNUC] may undergo endoscopic biopsy).
ADJUVANT THERAPY: Patients with pTR rate of > 10-49% are assigned to Treatment I and patients with pTR rate of ≥ 50% are assigned to Treatment II.
TREATMENT I: Starting at least 21 days after surgery, patients receive toripalimab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy (RT) once daily (QD) Monday-Friday for 6-7 weeks.
TREATMENT II: Starting at least 21 days after surgery, patients receive RT with or without concurrent chemotherapy per treating investigators per standard treatment guidelines.
Additionally, patients undergo blood sample collection and computed tomography (CT) or positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) throughout the study. Patients may also undergo tumor biopsy during screening.
After completion of study treatment, patients are followed up at 30 days then every 12 weeks for up to 1 year.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorGlenn J. Hanna
