Neoadjuvant Pembrolizumab Plus Chemotherapy in Locally Advanced Sinonasal Carcinoma

Istituti Clinici Scientifici Maugeri SpA2 sites in 1 country28 target enrollmentDecember 24, 2024

ConditionsSinonasal Undifferentiated Carcinoma

InterventionsPembrolizumab Docetaxel Carboplatin Cisplatin

DrugsDocetaxel Pembrolizumab Cisplatin Carboplatin

Overview

Phase: Phase 2
Intervention: Pembrolizumab
Conditions: Sinonasal Undifferentiated Carcinoma
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Enrollment: 28
Locations: 2
Primary Endpoint: Neoadjuvant therapy objective response rate (ORR)
Status: Recruiting
Last Updated: 16 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 24, 2024

End Date

December 1, 2027

Last Updated

16 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Responsible Party

Sponsor

Eligibility Criteria

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.
•A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
•o Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees use contraception during the treatment period and for at least 180 days (corresponding to time needed to eliminate any study treatments plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment.

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•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).
•Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
•Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Administration of killed vaccines is allowed.
•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.
•Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ (eg, breast carcinoma or cervical cancer in situ that have undergone potentially curative therapy are not excluded

Arms & Interventions

Neoadjuvant Pembrolizumab

Patients will receive pembrolizumab 200 mg + cisplatin 75mg/mq (or Carboplatin AUC 5) and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses, followed by standard of care.

Intervention: Pembrolizumab

Neoadjuvant Pembrolizumab

Patients will receive pembrolizumab 200 mg + cisplatin 75mg/mq (or Carboplatin AUC 5) and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses, followed by standard of care.

Intervention: Docetaxel

Neoadjuvant Pembrolizumab

Patients will receive pembrolizumab 200 mg + cisplatin 75mg/mq (or Carboplatin AUC 5) and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses, followed by standard of care.

Intervention: Carboplatin

Neoadjuvant Pembrolizumab

Patients will receive pembrolizumab 200 mg + cisplatin 75mg/mq (or Carboplatin AUC 5) and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses, followed by standard of care.

Intervention: Cisplatin