A Microdevice for Candidate Drug Screening in Patients with Skin Squamous Cell Carcinoma
This early phase I trial studies the safety of implanting and retrieving a microdevice for candidate drug screening in patients with skin (cutaneous) squamous cell carcinoma. There is a clinical need to predict drug response and select effective therapies in a personalized manner for patients with cutaneous squamous cell carcinoma. The microdevice used in this trial is smaller than a grain of rice and looks like a miniature push pin with a flat top that is glued to the external skin. The device supplies microdoses of cancer drugs that are so small that they are not meant to be a treatment for the cancer. This microdevice may be a possible safe tool to evaluate the effectiveness of several approved cancer drugs against cutaneous squamous cell carcinoma.
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.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).
- Absolute neutrophil count ≥ 500/mcL (within 28 days prior to the procedure).
- Platelets ≥ 50,000/mcL (within 28 days prior to the procedure).
- 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 microdevice (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 National Institutes of Health (NIH) central data repositories.
- Patient is considered to have capacity to properly follow instructions at home for the care of device(s).
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06782399.
Locations matching your search criteria
United States
Massachusetts
Boston
PRIMARY OBJECTIVES:
I. To determine the feasibility of microdevice analysis based on the ability to place and retrieve the device with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of at least 80% of the device reservoirs.
II. 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 OBJECTIVES:
I. To evaluate the safety of microdevice placement and removal based on assessment of adverse events.
II. To perform a preliminary assessment of the correlation between the extent of tumor response to drug with the microdevice and the clinical responses to systemic therapy (via disease measurements including clinical and/or radiographic evidence of disease response).
III. To explore additional potential biomarkers of drug response, including shifts in immune infiltrates in the local tumor tissue exposed to microdevice delivered drugs.
IV. 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.
V. To describe the genomic aberrations of the lesion tissue where microdevice(s) will be placed (using whole exome sequencing) and the transcriptional signatures of the lesion tissue not exposed to and exposed to drug (using ribonucleic acid [RNA] sequencing) and to perform a preliminary assessment of the correlation of genomic aberrations and perturbations in signaling pathways with extent of response to individual drugs.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
INITIAL COHORT 1: Patients undergo percutaneous placement of up to four total microdevice(s) into single skin lesions for 96 hours on study. Patients may receive any of the following drugs alone or in combination intradermally (ID) via the microdevice(s): 1) cemiplimab-rwlc, 2) pembrolizumab, 3) relatlima-rmbw/nivolumab, 4) avelumab, 5) ipilimumab, 6) cisplatin, 7) 5-flurouracil 8) cetuximab, 9) erlotinib, 10) trametinib, 11) afatinib, 12) palbociclib, 13) lenvatinib, 14) olaparib, 15) peginterferon alpha-2a, 16) aldesleukin, 17) doxorubicin. Patients then undergo surgical removal of the microdevice(s). In addition, patients undergo radiologic imaging scans throughout the trial. Patients may also undergo optional skin biopsies and collection of blood throughout the trial.
EXPANDED COHORT 2: Patients undergo percutaneous placement of up to four total microdevice(s) into single skin lesions for 96 hours on study. Patients may receive any of the drugs listed in Cohort 1 alone or in combination ID via the microdevice(s). Patients then undergo surgical removal of the microdevice(s), followed by standard of care (SOC) systemic therapy on study. Patients with residual disease after 12 weeks of SOC systemic therapy may undergo percutaneous placement of additional microdevice(s) and receive drugs as in Cohort 1 for 96 hours. Patients then undergo surgical removal of the additional microdevice(s). In addition, patients undergo radiologic imaging scans throughout the trial. Patients may also undergo optional skin biopsies and collection of blood throughout the trial.
After completion of study treatment, patients are followed every 8-12 weeks until 1 year from microdevice(s) placement.
Trial PhasePhase O
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorCecilia Alejandra Larocca
- Primary ID24-379
- Secondary IDsNCI-2025-01227
- ClinicalTrials.gov IDNCT06782399