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

NCT07455032 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

BIOLOGICAL

intradermal injection of CADI-05

CADI-05 will be administered intradermally. Participants will receive 0.2 mL on Day 1 of Week 1, followed by 0.1 mL on Day 1 of Weeks 2, 3, 4, and 5. If needed for safety, the CADI-05 dose will be reduced, and only be administered at 0.1ml on Day 1 of Weeks 2, 3, and 5.

BIOLOGICAL

Pembrolizumab

Pembrolizumab (standard of care treatment) will be administered intravenously at a dose of 200 mg on Day 1 of Week 1 and Day 1 of Week 4.

Sponsors & Collaborators

  • Cadila Pharnmaceuticals

    collaborator INDUSTRY

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Parth Desai · Fox Chase Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2027-11-30
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07455032 on ClinicalTrials.gov