Toripalimab plus carboplatin and docetaxel before surgery for sinonasal cancer
Perioperative Chemoimmunotherapy With Toripalimab for Sinonasal Cancer
This study tests whether giving toripalimab with carboplatin and docetaxel before surgery helps people with locally advanced sinonasal cancers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | toripalimab, chemotherapy, prednisone, immunotherapy |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06940180 on ClinicalTrials.gov |
What this trial studies
This single-arm, open-label phase II study gives toripalimab together with carboplatin and docetaxel as neoadjuvant therapy to people with resectable or borderline resectable sinonasal cancers. Participants will undergo screening, imaging (CT/MRI/PET), blood and urine tests, and tumor photography before and after treatment, followed by planned surgery. About 20 participants will be enrolled at Brigham and Women's Hospital/Dana‑Farber Cancer Institute, with study drug and funding provided by Coherus Biosciences. Toripalimab is a PD-1 monoclonal antibody intended to enhance immune response against tumors while carboplatin and docetaxel are chemotherapy agents aimed at shrinking the tumor.
Who should consider this trial
Good fit: Adults with histologically confirmed resectable squamous cell carcinoma or operable/borderline resectable sinonasal undifferentiated carcinoma of the nasal cavity or paranasal sinuses, staged per AJCC 8th edition, are the intended participants.
Not a fit: Patients with metastatic or clearly unresectable disease, other histologic tumor types outside SCC or SNUC, or those unable to travel to the study site are unlikely to benefit from this specific protocol.
Why it matters
Potential benefit: If successful, the treatment could shrink tumors before surgery, potentially allowing less extensive operations and improving outcomes.
How similar studies have performed: Similar approaches combining PD-1 inhibitors with chemotherapy have shown promise in other head and neck cancers and toripalimab is approved for nasopharyngeal carcinoma, but its use in sinonasal cancers is not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Glenn J Hanna, MD — Dana-Farber Cancer Institute
- Study coordinator: Glenn J Hanna, MD
- Email: glenn_hanna@dfci.harvard.edu
- Phone: 617-632-3090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.