Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas
Public ClinicalTrials.gov record NCT07455032. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas (LA-HNSCC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07455032
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 22 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 7, 2026
- Primary completion
- Nov 29, 2027
- Completion
- Jan 30, 2028
- Last update posted
- Apr 14, 2026
2026 – 2028
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | Recruiting |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07455032, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 14, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07455032 live on ClinicalTrials.gov.