Pembrolizumab in Locally Advanced Sinonasal Carcinoma
ConditionSinonasal Undifferentiated Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
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).
Trial design
Treatments tested in this trial
- Pembrolizumab
- Cisplatin
- Docetaxel
- Carboplatin
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov