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New treatment option for Sinonasal Cancer
Official title Toripalimab With Chemotherapy for Sinus Cancer
ClinicalTrials.gov ID: NCT06940180
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sinonasal cancer.
Also referred to as TAB-001, JS001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or cytologically confirmed locoregionally advanced nasal cavity or paranasal sinus cancer including the...
- Participants with SCC should have resectable disease at baseline per the discretion of the treating surgical oncologist(s). \ Participants with SNUC...
- Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by...
- T2, N1-3 III
- T3, any N III, IVA, IVB
You likely can't join if
- Participants with nasal cavity or paranasal sinus malignancies demonstrating histologies other than SCC or SNUC in the opinion of the reviewing...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Has a history of allogeneic tissue or solid organ transplant.
- Women who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.