Is NCT07455032 recruiting in Philadelphia, PA?

Yes, NCT07455032 is currently recruiting participants at its Philadelphia, PA location. This squamous cell carcinoma of head and neck clinical trial is actively enrolling qualified participants.

Is participation in this Philadelphia clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Squamous Cell Carcinoma of Head and Neck Clinical Trial in Philadelphia, PA

Q: How do I join the squamous cell carcinoma of head and neck clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Squamous Cell Carcinoma of Head and Neck Study in Philadelphia

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.

Sponsor: Fox Chase Cancer Center

Who Can Participate

Inclusion Criteria

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 Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT07455032) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Squamous Cell Carcinoma of Head and Neck Treatment Options in Philadelphia, PA

If you're searching for squamous cell carcinoma of head and neck treatment options in Philadelphia, PA, this clinical trial (NCT07455032) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced squamous cell carcinoma of head and neck specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all squamous cell carcinoma of head and neck clinical trials near you to find additional studies recruiting in your area.

Squamous Cell Carcinoma of Head and Neck Clinical Trial in Philadelphia, PA

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