Recruiting
Phase 2

Toripalimab, Carboplatin, Docetaxel

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06940180

Conditions

Sinonasal Cancer

Paranasal Sinus Neoplasms

Squamous Cell Carcinoma

Sinonasal Undifferentiated Carcinoma

Locally Advanced Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Toripalimab

Carboplatin

Docetaxel

Radiation Therapy

Cisplatin

Study Details

Brief 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)

Conditions

Sinonasal Cancer

Paranasal Sinus Neoplasms

Squamous Cell Carcinoma

Sinonasal Undifferentiated Carcinoma

Locally Advanced Head and Neck Cancer

Study ID

NCT06940180

Start date

Jun 17, 2025

Status verified date

Aug, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

Exclusion Criteria:

  • Participants with nasal cavity or paranasal sinus malignancies demonstrating histologies other than SCC or SNUC in the opinion of the reviewing pathologist. Excluded subtypes include: angiosarcomas, rhabdomyosarcomas, lymphomas, olfactory neuroblastomas (esthesioneuroblastomas), melanomas, and meningiomas among others. SNEC or sinonasal neuroendocrine carcinoma is not permitted.
  • Participants with unresectable or inoperable disease as judged by the treating surgical oncologist(s).
  • Participants with known distant metastatic disease (M1 or IVC).
  • Has received prior therapy with an anti-PD-1/L1 agent or any other agent directed to another stimulatory or co-inhibitory T-cell receptor.
  • Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Non-live vaccines are permitted.
  • Carries a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Exceptions may be permitted at the discretion of the overall Sponsor-Investigator.
  • Has an active autoimmune disease that has required systemic treatment in past 6 months (with use of a disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.
  • Has a history of (non-infectious) pneumonitis or interstitial lung disease that required steroids or has current pneumonitis or interstitial lung disease.
  • Has a known history of human immunodeficiency virus (HIV) infection that is uncontrolled. No HIV testing is required unless mandated by local health authority. Patients with well controlled HIV may be eligible if their CD4 T cell count is favorable and their HIV viral load is undetectable.
  • Has a known history of active Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
  • Has a history of allogeneic tissue or solid organ transplant.
  • Women who are pregnant or breastfeeding.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Toripalimab

An anti-PD-1 monoclonal antibody, single-use vial, via intravenous (into the vein) infusion per protocol.

Carboplatin

An antineoplastic agent, multi-dose vials, via intravenous (into the vein) infusion per standard of care.

Docetaxel

A taxoid antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.

Radiation Therapy

per standard of care

Cisplatin

An antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.

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 and Locations

Central contacts

Kartik Sehgal, MD

617-582-7322kartik_sehgal@dfci.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kartik Sehgal, MD

617-582-7322kartik_sehgal@dfci.harvard.edu

Principal Investigator:

Kartik Sehgal, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Kartik Sehgal, MD

617-582-7322kartik_sehgal@dfci.harvard.edu

Principal Investigator:

Kartik Sehgal, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-08-31.