Toripalimab With Chemotherapy for Sinus Cancer

NCT06940180 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25-121
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (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.

  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)

• Incidence of Adverse Events [Safety and Tolerability]

  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.

• Median Disease-free Survival (DFS)

  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.

• Median Overall Survival (OS)

  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

• Organ Preservation Rate

  Up to 42 days.

• Overall Response Rate (ORR)

  Up to 42 days.

Study Arms (3)

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

Drug: Toripalimab; Drug: Carboplatin; Drug: Docetaxel

Arm 2: Post Operative Radiation Therapy + Toripalimab

EXPERIMENTAL

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

Drug: Toripalimab; Radiation: Radiation Therapy

Arm 3: Post Operative Radiation Therapy With or Without Chemotherapy

EXPERIMENTAL

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

Radiation: Radiation Therapy; Drug: Cisplatin

Interventions

Toripalimab DRUG

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

Also known as: TAB-001, JS001, CHS-007, Loqtorzi, Toripalimab-tpzi

Arm 1: Toripalimab and Docetaxel Plus Carboplatin (TCD); Arm 2: Post Operative Radiation Therapy + Toripalimab

Carboplatin DRUG

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

Arm 1: Toripalimab and Docetaxel Plus Carboplatin (TCD)

Docetaxel DRUG

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

Also known as: Docefrez, Taxotere, C43H53NO14∙3H2O

Arm 1: Toripalimab and Docetaxel Plus Carboplatin (TCD)

Radiation Therapy RADIATION

per standard of care

Arm 2: Post Operative Radiation Therapy + Toripalimab; Arm 3: Post Operative Radiation Therapy With or Without Chemotherapy

Cisplatin DRUG

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

Also known as: Cl2H6N2Pt, Platinol, Platinol-AQ

Arm 3: Post Operative Radiation Therapy With or Without Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glenn J. Hanna: lead
• Coherus Oncology, Inc.: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Paranasal Sinus Neoplasms; Carcinoma, Squamous Cell; Sinonasal undifferentiated carcinoma; Head and Neck Neoplasms

Interventions

toripalimab; Carboplatin; Docetaxel; Radiotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Nose Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Nose Diseases; Respiratory Tract Diseases; Paranasal Sinus Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Glenn J Hanna, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glenn J Hanna, MD

CONTACT

617-632-3090; glenn_hanna@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 23, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)