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Cutaneous Squamous Cell CarcinomaPhase 1/2cSCCNCT05377905

Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)

A Phase 1/2 study testing Microneedle Array Doxorubicin (MNA-D) in people with Cutaneous Squamous Cell Carcinoma and Skin Cancers - Squamous Cell Carcinoma, run by Falo, Louis, MD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to test a new method of experimental treatment for cutaneous squamous cell skin cancer, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Microneedle Array Doxorubicin (MNA-D)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
13 Sep 2023to 31 Dec 2027
Phase
Phase 1/2
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

  • Subjects must have a histological diagnosis of cSCC based upon a skin biopsy.
  • Subjects must have resectable stage I-III disease.
  • Measures ≥5 millimeters (mm; post-biopsy) and <100 mm in longest diameter
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  • Subjects must have an expected survival of greater than or equal to 12 months.
  • Subjects must not be on any other investigational device/drug treatment.
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  • Subjects must be willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consent Form prior to entry into the study.
  • Subjects must have the following pretreatment laboratory parameters: granulocytes ≥1,500/mm3; platelets >50,000/mm3; serum creatinine ≤2X the upper limit of normal (ULN); AST, ALT ≤3X the ULN, bilirubin ≤1.5X ULN unless Gilbert's disease then ≤3X ULN.
  • Subjects must be at least 18 years of age and must be able to understand the written informed consent/assent document.
  • Subjects must have no evidence of active infection, regardless of the degree of severity or localization. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for study participation after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics before beginning treatment.
  • Subjects must not receive any other treatment for cSCC except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations.
  • Subjects with multiple cSCC may re-enroll in the study if greater than 4 weeks elapses between courses and if all other inclusion/exclusion criteria are met.
  • Patients with HIV infection with CD4+ T-cell (CD4+) counts ≥ 350 cells/uL will be eligible for the study. Patients without a history of AIDS-defining opportunistic infections will be eligible for the study.
  • Subjects must be willing/able to comply with standard of care measures for subjects with cSCC such as sun avoidance and sun protection.

Who cannot join

  • Subjects with the following tumor characteristics:
  • >4 mm depth;
  • Clark level IV;
  • perineural invasion, lymphovascular invasion;
  • primary site on the ear or non-glabrous lip;
  • location in the hands or feet;
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  • large size: ≥10 mm on neck or pretibial area; ≥20 mm on trunk or extremities;
  • indistinct borders;
  • rapid growth;
  • recurrent lesion;
  • lesion in site of chronic inflammation or prior radiation therapy;
  • presence of neurologic symptoms; or • poorly differentiated, and aggressive histopathologic subtypes.
  • Subjects with uncontrolled pain that would preclude participation in the study.
  • Subjects who are pregnant or lactating.
  • Subjects who have sensitivity to drugs that provide local anesthesia.
  • Impaired cardiac function or clinically significant cardiac disease, including any of the following:
  • Symptomatic congestive heart failure requiring treatment
  • Clinically significant cardiac arrhythmia
  • Uncontrolled hypertension
  • Corrected QT interval (QTc) >470 msec at Screening or congenital long QT syndrome
  • Acute myocardial infarction or unstable angina pectoris < 3 months prior to the first dose
  • New York Heart Association Functional Class III or higher (i.e. marked limitation of physical activity due to symptoms, or unable to carry on any physical activity without discomfort)
  • Subjects with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix.
  • Active, known, or suspected autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
  • Individuals with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, history of Hashimoto's thyroiditis on stable dose of thyroid hormone replacement therapy, adrenal insufficiency only requiring physiologic steroid replacement, or conditions not expected to recur should not be excluded.
  • Major surgery within 2 weeks of the first dose of study agent
  • History of or current drug-induced interstitial lung disease or pneumonitis Grade ≥2
  • Subjects with the disease only on the face, skin folds, head, scalp, and genital area.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Charity L Ruhl, LPN contact

1-412-647-2013

ruhlcl@upmc.edu

Nicolena Verardi contact

1-412-864-3682

verardin3@upmc.edu

United States1 site, 1 recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Charity L Ruhl, LPN, 4126472013, ruhlcl@upmc.edu

    Nicolena Verardi, PA-C, 412-864-3682, verardin3@upmc.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase Ib/II Study of Micro-needle Array Containing Doxorubicin in Immune Competent or Immune-suppressed Patients With Cutaneous Squamous Cell Carcinoma

The purpose of this study is to test a new method of experimental treatment for cutaneous squamous cell skin cancer, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. The overall goal of this study is to test the safety and effectiveness of these patches. The investigators have established the highest tolerated dose at 50 micrograms in a previous study for a different type of cancer that affects the skin. The investigators will thoroughly evaluate the skin where the patches are applied.

Read the detailed description

This study will evaluate a novel approach to the treatment of cutaneous squamous cell cancer (cSCC) of patients diagnosed previously by skin biopsy with cSCC utilizing a dissolvable microneedle array (MNA) delivery device that is used to directly and specifically deliver a drug to the tumor microenvironment for skin cancer therapy. The investigators will utilize MNAs to deliver a well-characterized, potent chemotherapeutic agent (doxorubicin) to kill topically accessible, cutaneous SCC cells. In addition to directly killing cancer cells, doxorubicin is known to induce an immunologic cell death with the potential to simultaneously convert a cutaneous neoplasm into a highly potent patient specific immunogen capable of inducing innate, adaptive, and tumor specific effector and memory immune responses. Importantly, doxorubicin is currently in clinical use with a well-established safety profile. It is anticipated that use of the MNA-Doxorubicin (MNA-D) delivery system will enable direct and specific delivery of chemotherapy to the tumor, thereby avoiding any potential for systemic toxicity. The study will be conducted using two groups: one group will consist of patients with immunocompetent immune systems and the second group will consist of patients who have had an organ transplant and are considered immunoincompetent.efficacy and safety evaluation. The first phase is now completed. Following a screening/baseline phase, the MNA-D patch application and assessment visits will occur from week 0 through week 3, followed by a rest week and at week 5, up to week 8, a final follow up visit will take place. At the final follow up visit, the remaining cSCC lesion will be removed in a standard of care manner to ensure that all tissue margins are clear of the cSCC.

Being tested
Microneedle Array Doxorubicin (MNA-D)
Keywords
micro-needle array, doxorubicin, patch

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microneedle Array Doxorubicin (MNA-D)Drug

    Also called MNA-D, Doxorubicin, Patch

    The Microneedle array patch is loaded/prepared with a total dose of 50 micrograms of Doxorubicin and is applied to a single selected cSCC remnant for a period of 20 minutes for a total of 4 weekly applications

Study groups in NCT05377905
Study groupRoleWhat they receive
Microneedle Array Doxorubicin (MNA-D)ExperimentalImmunocompetent and immuno-incompetent subjects will receive the MNA-D patch on 4 subsequent visits for a 20 minute time period at each application and will include patients who have competent immune systems with cSCC meeting all other inclusion/exclusion criteria and patients considered immuno-incompetent post transplant with cSCC meeting all other inclusion/exclusion criteria.
Receives: Drug: Microneedle Array Doxorubicin (MNA-D)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events grade 2 or higher to evaluate safety of MNA-D patches in cSCC

    Evaluated by assessing adverse events grade 2 or higher related to the MNA-D intervention

    Measured: Baseline up to week 8

Secondary outcomes (10)

  1. Change from baseline of local response to the MNA-D patch

    Percentage of tumor clearance of the area directly under the patch is measured..

    Measured: Baseline and follow up (weeks 5-8)

  2. Tumor clearance from baseline of locoregional (total area of the index lesion) response to the MNA-D Patch

    Percentage of tumor clearance from the entire cSCC lesion treated by the patch is measured including the area directly covered by the MNA and uncovered area of the treated lesion. .

    Measured: Baseline and follow up (weeks 5-8)

  3. Quantitative pathologic evaluation of tumor depth

    To provide a quantitative assessment of cSCC reduction after treatment, the remnant of cSCC tumors will be excised at week 5-8 and evaluated independently by 2 dermatopathologists in the blinded fashion. The depth of the cSCC will be measured.

    Measured: Follow up period (weeks 5-8)

  4. Flow cytometry quantitative biologic response evaluation in blood

    Flow cytometry will evaluate in-vivo tumor immune responses in the blood and will analyze total immune activity for increases and/or decreases in T cell populations of interest and other immune cells (e.g., MDSCs, NK cells, B cells, macrophages, dendritic cells) that could influence the frequency and phenotype of these populations.

    Measured: Baseline and follow up (weeks 5-8)

  5. Flow cytometry quantitative biologic response evaluation in tumor tissue

    Flow cytometry will evaluate in-vivo tumor immune responses in the excised tumor tissue and will analyze total immune infiltrates for increases and/or decreases in T cell populations of interest and other immune cells (e.g., MDSCs, NK cells, B cells, macrophages, dendritic cells) that could influence the frequency and phenotype of these populations.

    Measured: Baseline and follow up (weeks 5-8)

  6. Percentage of reduction in cSCC tumor

    To provide a quantitative assessment of cSCC reduction after treatment, the remnant of cSCC tumors will be excised at week 5-8 and evaluated independently by 2 dermatopathologists in the blinded fashion. The percentage of reduction in comparison to the original tumor will be reported.

    Measured: Baseline and follow up (weeks 5-8)

  7. Luminex quantitative biologic response in blood

    Luminex will evaluate in-vivo tumor immune responses for 65 selected serum biomarkers using a multiplex Luminex 100 (Bio-Rad Bio-Plex System) including G-CSF, GM-CSF, IFN-α, IFN-γ, IL-1β, IL-1RA, IL-2, IL-2R, IL-4, IL-5, IL-6, IL- 7, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, TNF-α, eotaxin, IP-10, MCP-1, MIG, MIP-1α, MIP-1β, RANTES, EGF, FGF-basic, HGF, and VEGF.

    Measured: Baseline and follow up (weeks 5-8)

  8. Serum SCC-Ag quantitative biologic response in blood

    Serum SCC-Ag levels will evaluate in-vivo tumor immune responses in the blood

    Measured: Baseline and follow up (weeks 5-8)

  9. Luminex quantitative biologic response evaluation in tumor tissue

    Luminex will evaluate in-vivo tumor tissue immune responses for 65 selected serum biomarkers using a multiplex Luminex 100 (Bio-Rad Bio-Plex System) including G-CSF, GM-CSF, IFN-α, IFN-γ, IL-1β, IL-1RA, IL-2, IL-2R, IL-4, IL-5, IL-6, IL- 7, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, TNF-α, eotaxin, IP-10, MCP-1, MIG, MIP-1α, MIP-1β, RANTES, EGF, FGF-basic, HGF, and VEGF.

    Measured: Baseline and follow up (weeks 5-8)

  10. Serum SCC-AG quantitative biologic response evaluation in tumor tissue

    Serum SCC-Ag levels will evaluate in-vivo tumor immune responses in the excised tumor tissue from baseline to week 8

    Measured: Baseline and follow up (weeks 5-8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start13 Sep 2023
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open-label, comparative 2-cohort design
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05377905
Sponsor's protocol ID
STUDY21090123
Other IDs
1P50CA254865-01A1
Acronym
cSCC
Status last verified
Apr 2026
First submitted
3 May 2022
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Madeleine MM, Patel NS, Plasmeijer EI, Engels EA, Bouwes Bavinck JN, Toland AE, Green AC; the Keratinocyte Carcinoma Consortium (KeraCon) Immunosuppression Working Group. Epidemiology of keratinocyte carcinomas after organ transplantation. Br J Dermatol. 2017 Nov;177(5):1208-1216. doi: 10.1111/bjd.15931. Epub 2017 Oct 10.

    PubMed 28994104

  • Hanlon A, Colegio OR. The cutting edge of skin cancer in transplant recipients: scientific retreat of international transplant Skin Cancer Collaborative and Skin Cancer in Organ Transplant Patients Europe. Am J Transplant. 2014 May;14(5):1012-5. doi: 10.1111/ajt.12681. Epub 2014 Mar 10.

    PubMed 24612476

  • Karia PS, Han J, Schmults CD. Cutaneous squamous cell carcinoma: estimated incidence of disease, nodal metastasis, and deaths from disease in the United States, 2012. J Am Acad Dermatol. 2013 Jun;68(6):957-66. doi: 10.1016/j.jaad.2012.11.037. Epub 2013 Feb 1.

    PubMed 23375456

  • Li YY, Hanna GJ, Laga AC, Haddad RI, Lorch JH, Hammerman PS. Genomic analysis of metastatic cutaneous squamous cell carcinoma. Clin Cancer Res. 2015 Mar 15;21(6):1447-56. doi: 10.1158/1078-0432.CCR-14-1773. Epub 2015 Jan 14.

    PubMed 25589618

  • Freeman A, Bridge JA, Maruthayanar P, Overgaard NH, Jung JW, Simpson F, Prow TW, Soyer HP, Frazer IH, Freeman M, Wells JW. Comparative immune phenotypic analysis of cutaneous Squamous Cell Carcinoma and Intraepidermal Carcinoma in immune-competent individuals: proportional representation of CD8+ T-cells but not FoxP3+ Regulatory T-cells is associated with disease stage. PLoS One. 2014 Oct 23;9(10):e110928. doi: 10.1371/journal.pone.0110928. eCollection 2014.

    PubMed 25340823

  • Farasat S, Yu SS, Neel VA, Nehal KS, Lardaro T, Mihm MC, Byrd DR, Balch CM, Califano JA, Chuang AY, Sharfman WH, Shah JP, Nghiem P, Otley CC, Tufaro AP, Johnson TM, Sober AJ, Liegeois NJ. A new American Joint Committee on Cancer staging system for cutaneous squamous cell carcinoma: creation and rationale for inclusion of tumor (T) characteristics. J Am Acad Dermatol. 2011 Jun;64(6):1051-9. doi: 10.1016/j.jaad.2010.08.033. Epub 2011 Jan 20.

    PubMed 21255868

  • Madan V, Lear JT, Szeimies RM. Non-melanoma skin cancer. Lancet. 2010 Feb 20;375(9715):673-85. doi: 10.1016/S0140-6736(09)61196-X.

    PubMed 20171403

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Microneedle Array Doxorubicin (MNA-D) in people with Cutaneous Squamous Cell Carcinoma and Skin Cancers - Squamous Cell Carcinoma, run by Falo, Louis, MD at 1 site 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 14 inclusion and 28 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 9 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 1 site 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Charity L Ruhl, LPN (1-412-647-2013, ruhlcl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events grade 2 or higher to evaluate safety of MNA-D patches in cSCC (time frame: Baseline up to week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05377905, which also lists 7 linked publications.

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 9 Apr 2026.

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