Actively Recruiting
Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas
Led by Fox Chase Cancer Center · Updated on 2026-04-15
22
Participants Needed
2
Research Sites
94 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
C
Cadila Pharnmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed new diagnosis of resectable, non-metastatic squamous cell carcinoma of head and neck as specified (Stage III HPV positive oropharyngeal T4 N0-2 M0; Stage III/IVA HPV negative oropharyngeal; Stage III/IVA larynx/hypopharynx/oral cavity with PD-L1 CPS 21).
- Planned definitive surgical resection determined by a multidisciplinary tumor board.
- Patients with recurrent or metachronous head and neck SCC allowed if surgery and pembrolizumab planned.
- Archival biopsy from primary tumor or lymph node with sufficient tumor tissue available.
- Age 18 years or older.
- ECOG performance status of 0 to 2.
- Consent to provide pre-treatment tissue biopsy and post-operative tissue for research.
- Adequate bone marrow, liver, and kidney function as demonstrated by specified laboratory values.
- Female patients must be surgically sterile, postmenopausal, or use effective contraception during treatment.
- Ability to understand and willingness to sign informed consent and HIPAA documents.
You will not qualify if you...
- Candidates for organ preservation via upfront chemoradiation therapy.
- Receiving any investigational agent currently or within 28 days before first CADI-05 dose.
- Active serious infection, unstable angina, uncontrolled cardiac arrhythmia, or recent myocardial infarction within 6 months.
- Active or prior autoimmune or inflammatory disorders within past 2 years, except specified mild conditions.
- Other prior or current malignancies except certain low-risk or disease-free cancers.
- Concurrent chemotherapy or investigational cancer treatments except specified hormonal therapies.
- Use of immunosuppressive medication within 14 days prior to first CADI-05 dose with some exceptions.
- Uncontrolled HIV infection with CD4+ T cells below 200 cells/mm3.
- Untreated or uncontrolled hepatitis C or active hepatitis B, except treated hepatitis B with undetectable virus.
- History of primary immunodeficiency or organ transplant.
- Pregnant or breastfeeding.
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Trial Site Locations
Total: 2 locations
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
2
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
Research Team
P
Parth Desai, MD, MBBS
CONTACT
J
Jianli Hu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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