Pembrolizumab in Locally Advanced Sinonasal Carcinoma
Italy28 participantsStarted 2024-12-24
Plain-language summary
This study will test the Safety and activity of pembrolizumab plus chemotherapy as neoadjuvant treatment in locally advanced sinonasal undifferentiated carcinoma (SNUC).
Activity of neoadjuvant chemotherapy in locally advanced SNUC has been already demonstrated; the primary hypothesis is that the addition of pembrolizumab as neoadjuvant and adjuvant agent might confirm the results obtained with a combined treatment strategy including chemotherapy, decreasing the burden of treatment-related side effects.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have centrally histologically-confirmed, treatment-naïve SNUC that is considered curable by local therapies.
✓. Have locally advanced disease defined as stage III of IV a-b according to American Joint Committee on Cancer (AJCC) cancer staging system VIII edition.
✓. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
✓. Be ≥ 18 years of age on day of signing informed consent.
✓. Have measurable disease based on RECIST 1.1 as determined by the site.
✓. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
✓. Demonstrate adequate organ function.
✓. A male participant must agree to use contraception during the treatment period and for at least 180 days after last dose, corresponding to time needed to eliminate any study treatments plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity. He must refrain from donating sperm during this period, too.
Exclusion criteria
✕. Has disease that is deemed not suitable for local therapy administered with curative intent (e.g. severe brain involvement).
✕. 2\. Have metastatic disease defined as stage IV c according to AJCC cancer staging system VIII edition.
What they're measuring
1
Neoadjuvant therapy objective response rate (ORR)
Timeframe: Up to 24 months after the end of neoadjuvant treatment
✕. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
✕. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
✕. Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
✕. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
✕. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing 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.