Toripalimab With Chemotherapy for Sinus Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Glenn J. Hanna
Study ID
NCT06940180
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Locally Advanced Head and Neck Cancer
  • Paranasal Sinus Neoplasms
  • Sinonasal Cancer
  • Sinonasal Undifferentiated Carcinoma
  • Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Toripalimab — DRUG
    An anti-PD-1 monoclonal antibody, single-use vial, via intravenous (into the vein) infusion per protocol.
  • Carboplatin — DRUG
    An antineoplastic agent, multi-dose vials, via intravenous (into the vein) infusion per standard of care.
  • Docetaxel — DRUG
    A taxoid antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.
  • Radiation Therapy — RADIATION
    per standard of care
  • Cisplatin — DRUG
    An antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.

Study Details

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)

Key Dates

Start date
Jun 17, 2025
Status verified
Jun 2025
Primary completion
Feb 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Pathologic Treatment Response Rate (pTRR) [ Time Frame: Tumor assessments or scans will be obtained at baseline and 3-months following the end of treatment. Treatment duration is not fixed and this observation time is variable, criteria for discontinuation is outlined in protocol section 5.10. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Glenn J Hanna, MD
[email protected]
617-632-3090
Glenn J Hanna, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Glenn J Hanna, MD
[email protected]
617-632-3090
Glenn J Hanna, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

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By specialty
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By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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