Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:13 AM
Study NCT ID:
NCT07455032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas (LA-HNSCC)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 25-1040 | OTHER | Fox Chase Cancer Center IRB | View |