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Sinonasal CancerPhase 2NCT06940180

Toripalimab With Chemotherapy for Sinus Cancer

A Phase 2 study testing Toripalimab, Carboplatin and Docetaxel in people with Sinonasal Cancer and Paranasal Sinus Neoplasms, run by Dana-Farber Cancer Institute at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Toripalimab, Carboplatin and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
17 Jun 2025to 1 Feb 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kartik Sehgal, MD contact

617-582-7322

kartik_sehgal@dfci.harvard.edu

United States2 sites, 2 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Kartik Sehgal, MD, 617-582-7322, kartik_sehgal@dfci.harvard.edu

    Kartik Sehgal, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Kartik Sehgal, MD, 617-582-7322, kartik_sehgal@dfci.harvard.edu

    Kartik Sehgal, MD

    Recruiting

Other trials in United States

About this study

Official title: Perioperative Chemoimmunotherapy With Toripalimab for Sinonasal Cancer

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)
Read the detailed description

This single-arm, open-label, single-center phase II 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.

Toripalimab binds to the PD-1 receptors on T-cells (immune cells) and prevents them from interacting with PD-L1 and PD-L2 on tumor cells. This stimulates the immune system to fight tumor cells.

The U.S. Food and Drug Administration (FDA) has not approved Toripalimab for sinonasal cancers, but it has been approved for another type of head and neck cancer called nasopharyngeal carcinoma (NPC), in the advanced incurable setting when surgery is no longer possible, or when cancer has spread to parts of the body outside the head and neck region.

Carboplatin and Docetaxel have been approved by the FDA in the advanced incurable setting for other types of head and neck cancer.

The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, X-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, and photographic images of tumors.

It is expected that about 20 people will take part in this research study.

Coherus Biosciences, a pharmaceutical company, is funding this research study by providing the study drug and funding for the research study.

Being tested
Toripalimab, Carboplatin, Docetaxel, Radiation Therapy, Cisplatin
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
Medical subject headings
Paranasal Sinus Neoplasms, Carcinoma, Squamous Cell, Sinonasal undifferentiated carcinoma, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToripalimabDrug

    Also called TAB-001, JS001, CHS-007, Loqtorzi

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

  • CarboplatinDrug

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

  • DocetaxelDrug

    Also called Docefrez, Taxotere, C43H53NO14∙3H2O

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

  • Radiation TherapyRadiation

    per standard of care

  • CisplatinDrug

    Also called Cl2H6N2Pt, Platinol, Platinol-AQ

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

Study groups in NCT06940180
Study groupRoleWhat they receive
Arm 1: Toripalimab and Docetaxel Plus Carboplatin (TCD)Experimental* 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
Receives: Drug: Toripalimab; Drug: Carboplatin; Drug: Docetaxel
Arm 2: Post Operative Radiation Therapy + ToripalimabExperimentalAfter 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
Receives: Drug: Toripalimab; Radiation: Radiation Therapy
Arm 3: Post Operative Radiation Therapy With or Without ChemotherapyExperimentalAfter 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
Receives: Radiation: Radiation Therapy; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Treatment Response Rate (pTRR)

    pTRR is defined as the proportion of participants that experience a complete pathologic response or partial pathologic response during treatment, as defined in the RECIST criteria.

    Measured: 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.

Secondary outcomes (7)

  1. Incidence of Adverse Events [Safety and Tolerability]

    Safety and tolerability assessed by CTCAE v5.0 and summarized descriptively.

    Measured: Adverse events are collected every study visit through study completion, an average of 1 year. Treatment duration is not fixed and this observation time is variable, criteria for discontinuation is outlined in protocol section 5.10.

  2. Median Disease-free Survival (DFS)

    Disease-free survival (PFS) is defined as the time from the date of study registration to first invasive local, regional, distant recurrence, or death due to any cause. Participants alive without disease are censored at date of last disease evaluation.

    Measured: 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.

  3. Median Overall Survival (OS)

    OS is Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.

    Measured: Participants will be followed for 1-year (12 months) after completion or removal from protocol therapy or until death, whichever occurs first. Treatment duration is not fixed and this observation time is variable, criteria for discontinuation is outlined

  4. Organ Preservation Rate

    Defined as the percentage of patients with an intact orbit, palate, and skull base immediately post-op from definitive oncologic resection among the study cohort.

    Measured: Up to 42 days.

  5. Overall Response Rate (ORR)

    ORR is the proportion of participants that experience complete response (CR) or partial response (PR) recorded from the start of the TCD treatment to the first imaging just prior to surgery.

    Measured: Up to 42 days.

  6. Correlation between tumor PD-L1 combined positive score (CPS) with pTR

    PD-L1 CPS values range from 0-100. Higher scores are considered positive.

    Measured: 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

  7. Correlation between tumor PD-L1 combined positive score (CPS) with survival outcomes

    PD-L1 CPS values range from 0-100. Higher scores are considered positive.

    Measured: Participants will be followed for 1-year (12 months) after completion or removal from protocol therapy or until death, whichever occurs first. Treatment duration is not fixed and this observation time is variable per protocol.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2025
  2. Study start17 Jun 2025
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06940180
Sponsor's protocol ID
25-121
Status last verified
Aug 2026
First submitted
9 Apr 2025
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab, Carboplatin and Docetaxel in people with Sinonasal Cancer and Paranasal Sinus Neoplasms, run by Dana-Farber Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kartik Sehgal, MD (617-582-7322, kartik_sehgal@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06940180.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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