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New treatment option for Squamous Cell Carcinoma of Head and Neck
Official title Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas
ClinicalTrials.gov ID: NCT07455032
What this study is testing
What is intradermal injection of CADI-05?
intradermal injection of CADI-05 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for squamous cell carcinoma of head and neck.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV)...
- Patients with recurrence or metachronous primary SCC of head and neck origins with previous history of surgery/radio (chemo)-therapy are allowed if...
- Patients must have an archival biopsy from the primary tumor site or regional lymph nodal metastasis with adequate tumor tissue as judged by study...
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
You likely can't join if
- 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...
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis, Crohn's disease]...
- Other prior or concomitant malignancies with the exception of:
- Non-melanoma skin cancer
See the full eligibility 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...
- 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...
- 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...
- 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.
- people 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.