Squamous Cell Carcinoma of Head and NeckPhase 1NCT07455032
Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas
A Phase 1 study testing intradermal injection of CADI-05 and Pembrolizumab in people with Squamous Cell Carcinoma of Head and Neck, run by Fox Chase Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- intradermal injection of CADI-05 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2026to 31 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Parth Desai, MD, MBBS, 215-728-4300, Parth.Desai@fccc.edu
Jianli Hu, MD, PhD, 267-449-1431, Jianli.Hu@fccc.edu
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Parth Desai, MD, MBBS, 215-707-7777, Parth.Desai@fccc.edu
Jianli Hu, MD, PhD, 267-449-1431, Jianli.Hu@fccc.edu
About this study
Official title: Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas (LA-HNSCC)
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?
Read more
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
- Being tested
- intradermal injection of CADI-05, Pembrolizumab
- Keywords
- Squamous cell Carcinoma of Head and Neck, CADI-05, Pembrolizumab, Immunotherapy, Neoadjuvant, Surgery, Locally advanced
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradermal injection of CADI-05Biological
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.
PembrolizumabBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with CADI-05 and pembrolizumab | Experimental | the neoadjuvant CADI-05 with pembrolizumab Receives: Biological: intradermal injection of CADI-05; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
Measured: From the first treatment of CADI-05 through study completion, an average of 27 months.
Secondary outcomes (1)
The major pathological response (mPR) rates on post-treated surgical tumor specimens among patients treated at the MTD of CADI-05.
mPR is defined as the proportion of residual tumor cells was less than 10% of the total tumor involved in primary and draining nodal specimens from pathological examination of resected specimens.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start8 Apr 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cadila Pharnmaceuticals
- Responsible party
- Sponsor
- Investigators
- Parth Desai, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455032
- Sponsor's protocol ID
- HN-227
- Other IDs
- 25-1040
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas (LA-HNSCC)
- ClinicalTrials.gov ID
- NCT07455032
- Acronym / sponsor ID
- HN-227
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Squamous cell Carcinoma of Head and Neck, CADI-05, Pembrolizumab, Immunotherapy, Neoadjuvant, Surgery, Locally advanced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Cadila Pharnmaceuticals
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with CADI-05 and pembrolizumab | Experimental | Biological: intradermal injection of CADI-05, Biological: Pembrolizumabthe neoadjuvant CADI-05 with pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intradermal injection of CADI-05CADI-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 | Treatment with CADI-05 and pembrolizumab |
| PembrolizumabPembrolizumab (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. | Biological | Treatment with CADI-05 and pembrolizumab |
Primary outcome
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.
Time frame: 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.
Time frame: From the first treatment of CADI-05 through study completion, an average of 27 months.
1 secondary outcome
The major pathological response (mPR) rates on post-treated surgical tumor specimens among patients treated at the MTD of CADI-05.
Time frame: At the time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Parth Desai principal investigator
Fox Chase Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing intradermal injection of CADI-05 and Pembrolizumab in people with Squamous Cell Carcinoma of Head and Neck, run by Fox Chase Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Parth Desai, MD, MBBS (215-707-7777, Parth.Desai@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From Day 1 of CADI-05 treatment until safety follow-up, for a total of up to 13 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.