Drug Screening of Cutaneous Lesions of Squamous Cell Carcinoma

Early Phase 1

Not yet recruiting

• Conditions: Squamous Cell Carcinoma of the Skin; Squamous Cell Carcinoma

• Registration Number: NCT06782399
• Lead Sponsor: Oliver Jonas

Brief Summary

This research study is studying the effect of different drugs as possible treatments for squamous cell carcinoma (SCC).

Detailed Description

The pilot study will determine the feasibility of using an in situ microdevice to measure local intratumoral response to several cancer treatments in patients with cutaneous lesions of squamous cell carcinoma.

This research study is a Pilot Study, which is the first-time investigators are examining this study device in SCC. The treatment received will be the normal standard-of-care treatment for SCC However, the placement and removal of the microdevice is being tested for the first time in this type of cancer.

This research study involves drugs that are released by a small implantable microdevice (IMD) as small as the tip of a needle, that is inserted into the tumor and is then removed 3-5 days later. The microdevice can hold up to 20 drugs in very small concentrations that are able to access the cancer through small pores in the device. When the device is removed along with the cancer 3-5 days later, it will be evaluated to understand which drug(s) may be effective to treat these cancers.

The U.S. Food and Drug Administration (FDA) has not approved the microdevice a treatment for any disease.

AACRF, a research foundation, is supporting this research study by providing funding for the research study, the study drugs and study procedures

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Study Start: 2025-07
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Participants must have clinical diagnosis of cutaneous squamous cell carcinoma or metastatic squamous cell carcinoma with cutaneous involvement supported by histological evaluation of skin lesions based upon available clinical data including pathology reports from non-study institution (if applicable)
• Participants must have visible cutaneous disease. Skin lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• A single lesion is amenable to placement of one or multiple devices in terms of lesion size and location, as assessed by dermatologist (minimum lesion diameter of 1.0 cm).
• Washout period from previous treatments is not necessary.
• Age minimum of age 18. Because of limited incidence of cutaneous squamous cell carcinoma in the pediatric population, children are excluded from this study.
• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
• Participants will undergo laboratory testing within 28 days prior to the procedure. Participants must have marrow function as defined below:

absolute neutrophil count ≥500/mcL platelets ≥50,000/mcL

• Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the efficacy assessment of the systemic regimen are eligible for this trial in the systemic treatment cohort (expansion cohort).
• Participants must be evaluated by a dermatologist or medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease. Systemic therapy will be mandatory for expansion/systemic treatment cohort. Systemic therapy may be initiated anytime within 4 weeks of MD removal.
• Patients must be deemed medically stable to undergo percutaneous procedures by their treating cutaneous oncologist.
• Ability to understand and the willingness to sign a written informed consent document.
• Patients must be willing to undergo research-related genetic and transcriptomic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.
• Patient is considered to have capacity to properly follow instructions at home for the care of device(s) (see Appendix B).

Exclusion Criteria

• Positive serum pregnancy test at screening visit. Pregnant women are excluded from this study because the agents used for microdosing have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is enrolled in this study.
• Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients who will receive standard of care systemic therapy in expansion cohort are not allowed to start any new skin directed therapy (e.g. topical 5-fluorouracil, imiquimod, etc.) concurrent with first systemic therapy initiated after device implantation and retrieval. Should a patient clinically progress on first systemic therapy and require a change in treatment, skin directed therapies may be introduced if desired.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of analysis	through study completion, an average of 1 year	For the feasibility endpoint, a "successful" procedure will be defined as the ability to retrieve the device (by either skin punch biopsy tool or surgical excision) without damaging tumor tissue surrounding the microdevice, and with a rim of tissue of at least 500um thickness surrounding the microdevice, to allow for downstream immunohistochemistry analysis. At least 80% of the device reservoirs need to be surrounded by tissue in order to be considered successful.; For purposes of this endpoint, feasibility will be assessed on a per-device basis rather than a per-patient basis, with each device considered relatively independent in terms of placement, retrieval, and analysis.
Cell death index measurement	through study completion, an average of 1 year	To identify which microdosed targeted or chemotherapeutic cancer agents, delivered by an implantable microdevice in cutaneous lesions of squamous cell carcinoma in the expansion cohort, induce a cell death index value of at least 30% based on quantitative histopathologic assessment.; To identify which microdosed targeted or chemotherapeutic cancer agents, delivered by an implantable microdevice in cutaneous lesions of squamous cell carcinoma in the expansion cohort, induce a cell death index value of at least 30% based on quantitative histopathologic assessment.; To identify which microdosed targeted or chemotherapeutic cancer agents, delivered by an implantable microdevice in cutaneous lesions of squamous cell carcinoma in the expansion cohort, induce a cell death index value of at least 30% based on quantitative histopathologic assessment.

Secondary Outcome Measures

Name	Time	Method
Correlation between tumor-drug response on microdevice and clinical response to systemic treatment	through study completion, an average of 1 year	We will perform a preliminary assessment of the statistical correlation between the extent of tumor response to drug with the microdevice (measured using immunohistochemical analysis of drug-exposed tumor tissue for markers of apoptosis and cell proliferation) and the clinical responses to systemic therapy (via disease measurements including clinical and/or radiographic evidence of disease response).
Additional biomarker identification	through study completion, an average of 1 year	Immune infiltrates in the local tumor tissue exposed to microdevice delivered drugs.
Intralesional heterogeneity assessment	through study completion, an average of 1 year	To assess intralesional heterogeneity in drug response by comparing the extent of tumor response to drug among different locations in a single tumor with multiple microdevices.
Safety	through study completion, an average of 1 year	To evaluate the safety of microdevice placement and removal based on assessment of adverse events.