Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas

The goal of this clinical trial is to learn if drug CADI-05, when used together with pembrolizumab (an FDA approved immunotherapy), can help treat locally advanced head and neck squamous cell carcinoma (LA-HNSCC) in adults. It will also learn about the safety of drug CADI-05. The main questions it aims to answer are: * Does using CADI-05 together with pembrolizumab help the immune system fight cancer better and lead to better results for patients? * What side effects or health problems might happen when people receive these two treatments? Participants will: * Get pembrolizumab by IV (through a vein) once on day 1 of week 1 and again day 1 of week 4. This is standard of care treatment. * Get CADI-05 as a small injection into the skin once a week for 5 weeks. This is the experimental (research) treatment. * Visit the clinic every week for treatments, checkups and tests for 5 weeks. * Have surgery between week 6 and week 7. * Return to the clinic once for a follow-up visit about 30 days after surgery.

NCT Number	NCT07455032
Lead Sponsor	Fox Chase Cancer Center Collaborators: Cadila Pharnmaceuticals
Conditions	Squamous Cell Carcinoma of Head and Neck
Enrollment	22 participants
Start Date	2026-04-08
Primary Completion	2027-11-30 (estimated)
Study Completion	2028-01-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-15