CADI-05 with Pembrolizumab for Head and Neck Squamous Cell Carcinoma
This study is looking at CADI-05, a new treatment, when given along with pembrolizumab (an approved immunotherapy) for adults with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The main goals are to see if this combination can help your immune system fight cancer better and to understand any side effects that might happen. You would receive pembrolizumab through an IV (into a vein) twice, and CADI-05 as a small injection into the skin once a week for five weeks. This study is for people with a new diagnosis of resectable (can be removed by surgery), non-metastatic (hasn't spread) squamous cell carcinoma of the head and neck, with specific tumor characteristics. The study plans to enroll 22 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 22 participants, but the phase is not specified.
- What's involved
- You would receive pembrolizumab by IV twice and CADI-05 as a skin injection once a week for five weeks. The study will monitor for side effects for up to 13 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for side effects for up to 13 weeks, and for other health problems for an average of 27 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07455032
Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas
Recruiting
PHASE1Ages 18+InterventionalTreatmentFox Chase Cancer CenterInvestigator-initiated
~22 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:intradermal injection of CADI-05Pembrolizumab
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of dose limiting toxicities (DLTs) by CTCAE ver. 6.0. of CADI-05 and pembrolizumab in patients with surgically resectable LA-HNSCC during the toxicity assessment window.
Measured over From Day 1 of CADI-05 treatment until safety follow-up, for a total of up to 13 weeks.
+1 more outcome measured
Conditions
Where it's being run
2 sites across 1 statesPennsylvania2
Study leadership
- Parth Desai · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries (AJCC 8th edition) with programmed death ligand -1 (PD-L1) combined positive score (CPS) ≥ 1 (as determined by any clinical pathology laboratory) Patients must be planned for definitive surgical resection as determined by a multidisciplinary tumor board or equivalent multidisciplinary determination.
Patients with recurrence or metachronous primary SCC of head and neck origins with previous history of surgery/radio (chemo)-therapy are allowed if definitive surgery is planned and if pembrolizumab is planned as a neoadjuvant strategy. Patients should have recovered from the effects of radiation or other prior treatments: AE/sequelae should resolve to ≤ grade 2 (no minimum recovery period required).
Patients must have an archival biopsy from the primary tumor site or regional lymph nodal metastasis with adequate tumor tissue as judged by study PI. There should not be any oncological treatments between the pre-CADI-05 biopsy and W1 Pembrolizumab/CADI-05 treatment initiation. Note: If pretreatment material is a cytology specimen and deemed unsuitable for correlative testing, a core biopsy will be strongly recommended.
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Patients must consent to provide either archival (if available \& sufficient) or fresh pre-treatment tissue biopsy for research, and consent for the use of their residual post-operative tissue for research.
Adequate bone marrow, liver and kidney function as demonstrated by:
Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
Hgb \> 7 g/dL (use of transfusion to reach this threshold prior to study initiation is acceptable)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.5
upper limit of normal (ULN)
Total serum bilirubin ≤1.5 ULN
Patients with suspected Gilbert's disease may enroll provided that total bilirubin must be \< 3 mg/dL
Creatinine clearance (CrCL) \> 30 mL/min as measured via Cockcroft-Gault
Female patients must be surgically sterile or be postmenopausal or must use highly effective contraception while receiving trial treatment.
Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.
Exclusion
Patients who are considered candidates for organ preservation through upfront concurrent chemoradiation therapy will be excluded from this study.
Receiving any investigational agent currently or within 28 days of first dose of CADI-05.
Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the subject or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction ≤ 6 months prior to study entry.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis, Crohn's disease\]; diverticulitis with the exception of a prior episode that has resolved or diverticulosis; celiac disease; irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \[granulomatosis with polyangiitis\]; myasthenia gravis; rheumatoid arthritis; hypophysitis, uveitis; etc.) within the past 2 years prior to the start of treatment. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
Other prior or concomitant malignancies with the exception of:
Non-melanoma skin cancer
In-situ malignancy or any other malignancy that does not affect the primary management of the HNSCC under consideration including delivery of neoadjuvant pembrolizumab and definitive surgery plan.
Low-risk prostate cancer after curative therapy
Other cancer for which the subject has been disease free for ≥ 2 years before the first dose of study drug and of low potential risk for recurrence.
Any concurrent chemotherapy, investigational treatment, biologic or hormonal therapy for cancer treatment except adjuvant intent hormonal therapy for definitively treated breast or prostate cancer that has not recurred in last 2 years. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable.
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of CADI-05. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (e.g. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiological doses not to exceed 10mg/day of prednisone or equivalent. \[NOTE: If systemic corticosteroids are part of the treatment regimen for the indication under study, the systemic corticosteroid is permitted\].
Uncontrolled human immunodeficiency virus (HIV) infection with CD4+ T \< 200 cells/mm3.
Untreated or uncontrolled hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV). Patients with hepatitis B receiving treatment with anti- HBV therapy and having undetectable virus titers will be included.
History of primary immunodeficiency.
History of organ transplant.
Pregnant or breastfeeding. Refer to section 4.4 for further detail.
What this trial measures
- Occurrence of dose limiting toxicities (DLTs) by CTCAE ver. 6.0. of CADI-05 and pembrolizumab in patients with surgically resectable LA-HNSCC during the toxicity assessment window.From Day 1 of CADI-05 treatment until safety follow-up, for a total of up to 13 weeks.
- Occurrence of Grade 3 and higher AEs by CTCAE ver. 6.0. of CADI-05 and pembrolizumab in patients with surgically resectable LA-HNSCC during the toxicity assessment period at the MTD of CADI-05.From the first treatment of CADI-05 through study completion, an average of 27 months.