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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 2, 2026 to Apr 8, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07455032
Lead Sponsor Fox Chase Cancer Center
Collaborators: Cadila Pharnmaceuticals
Conditions
(from sponsor)		 Squamous Cell Carcinoma of Head and Neck
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov