Perioperative Chemoimmunotherapy With Toripalimab for Sinonasal Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

• Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):

‣ T2, N1-3 III

⁃ T3, any N III, IVA, IVB

⁃ T4, any N IVA, IVB

• Participants must be willing to provide blood and tissue pre-treatment and at the time of surgery for pathologic and correlative analyses.

• Age 18 years or older at the time of informed consent.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Participants must have adequate organ and marrow function as defined below:

‣ Absolute neutrophil count ≥1000/mcL

⁃ Platelets ≥100

⁃ Total bilirubin ≤institutional upper limit of normal (ULN)

⁃ AST(SGOT) / ALT (SGPT) ≤3x ULN

⁃ Creatinine ≤institutional ULN or GFR of ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2

• Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Contraception use should be maintained until at least 6 months after the last dose of chemotherapy for females and 3 months for males. In addition, contraception use should continue until 4 months after last dose of toripalimab for both males and females.

• Ability to understand and the willingness to sign a written informed consent document.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Glenn J Hanna, MD
glenn_hanna@dfci.harvard.edu
617-632-3090
Time Frame
Start Date: 2025-06-17
Estimated Completion Date: 2029-02-01
Participants
Target number of participants: 20
Treatments
Experimental: Arm 1: Toripalimab and Docetaxel Plus Carboplatin (TCD)
* Baseline visit with imaging~* Cycles 1 and 2 (21 day cycles)~ * Day 1: Predetermined dose of Toripalimab 1x daily~ * Day 1: Chemotherapy: predetermined dose of Docetaxel 1x daily and Carboplatin 1x daily~* Tumor assessment by imaging~* Surgical resection of tumor
Experimental: Arm 2: Post Operative Radiation Therapy + Toripalimab
After pathology assessment, participants with a pathological treatment response of 2 will be assigned radiation therapy per standard practice guidelines and predetermined dose of Toripalimab 1x every 3 weeks for up to 8 cycles (21 day cycles).~-Follow up: every 3 months for 1 year. Imaging at 3 months
Experimental: Arm 3: Post Operative Radiation Therapy With or Without Chemotherapy
After pathology assessment, participants with a pathological treatment response of 2 or less will be assigned standard radiation therapy with or without standard of care Cisplatin-based chemotherapy as recommended per treatment team and standard practice guidelines.~-Follow up: every 3 months for 1 year. Imaging at 3 months
Related Therapeutic Areas
Sponsors
Leads: Glenn J. Hanna
Collaborators: Coherus Oncology, Inc.

This content was sourced from clinicaltrials.gov

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