Squamous Cell Carcinoma of the SkinEarly Phase 1SCCNCT06782399
Drug Screening of Cutaneous Lesions of Squamous Cell Carcinoma
A Early Phase 1 study testing Microdevice in people with Squamous Cell Carcinoma of the Skin and Squamous Cell Carcinoma, run by Oliver Jonas at 1 site in United States.
Trial summary
This research study is studying the effect of different drugs as possible treatments for squamous cell carcinoma (SCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Skin, Squamous Cell Carcinoma
- What is being tested?
- Microdevice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to Jul 2028
- Phase
- Early Phase 1
- 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
- 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).
Show all 17Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dana Farber Cancer Insitute
Boston, Massachusetts, 02115
About this study
Official title: A Pilot of a Microdevice for In Situ Candidate Drug Screening of Cutaneous Lesions of Squamous Cell Carcinoma
This research study is studying the effect of different drugs as possible treatments for squamous cell carcinoma (SCC).
Read the 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
- Being tested
- Microdevice
- Keywords
- Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Skin, Implantable Microdevice
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrodeviceCombination product
Device: Microdevices
The microdevice is an investigational miniaturized implantable nanodose drug delivery device. It was developed as a tool with the ultimate goal to help screen several existing and investigational drugs directly within a patient's tumor to identify what drugs are the most effective for treating a patient's cancer. The microdevice releases nanodoses of several approved drugs into the tumor, and is then excised minimally invasively several days later.
Other: Standard of care therapy
Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which may include a skin-directed or systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| Local treatment cohort | Experimental | Local Treatment Cohort (5 participants) may recruit participants who plan to receive local surgical intervention (Mohs surgery or local excision) alone or in combination with further surgical treatment, radiation, or systemic therapy. Receives: Combination Product: Microdevice |
| Systemic treatment cohort | Experimental | Systemic Treatment Cohort (20 patients) will not enroll until initial cohort has been completed (MD have been implanted, retrieved, and processed for immunohistochemical analysis). Microdevice protocol will be optimized given results derived from the local treatment cohort. Will include participants who plan to receive systemic therapy in the absence of additional local therapy (surgery or radiation). If patients receive systemic therapy, and there is clinical cutaneous residual disease after 12 weeks of systemic therapy, an additional 1 to 4 MDs will be implanted into residual cutaneous disease at this time. Receives: Combination Product: Microdevice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of analysis
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.
Measured: through study completion, an average of 1 year
Cell death index measurement
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Safety
To evaluate the safety of microdevice placement and removal based on assessment of adverse events.
Measured: through study completion, an average of 1 year
Correlation between tumor-drug response on microdevice and clinical response to systemic treatment
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).
Measured: through study completion, an average of 1 year
Additional biomarker identification
Immune infiltrates in the local tumor tissue exposed to microdevice delivered drugs.
Measured: through study completion, an average of 1 year
Intralesional heterogeneity assessment
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Oct 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oliver Jonas
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Sponsor-investigator, Oliver Jonas, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782399
- Sponsor's protocol ID
- 24-379
- Acronym
- SCC
- Status last verified
- May 2026
- First submitted
- 3 Jan 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot of a Microdevice for In Situ Candidate Drug Screening of Cutaneous Lesions of Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06782399
- Acronym / sponsor ID
- SCC / 24-379
- Keywords
- Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Skin, Implantable Microdevice
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Oliver JonasUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local treatment cohort | Experimental | Combination Product: MicrodeviceLocal Treatment Cohort (5 participants) may recruit participants who plan to receive local surgical intervention (Mohs surgery or local excision) alone or in combination with further surgical treatment, radiation, or systemic therapy. |
| Systemic treatment cohort | Experimental | Combination Product: MicrodeviceSystemic Treatment Cohort (20 patients) will not enroll until initial cohort has been completed (MD have been implanted, retrieved, and processed for immunohistochemical analysis). Microdevice protocol will be optimized given results derived from the local treatment cohort. Will include participants who plan to receive systemic therapy in the absence of additional local therapy (surgery or radiation). If patients receive systemic therapy, and there is clinical cutaneous residual disease after 12 weeks of systemic therapy, an additional 1 to 4 MDs will be implanted into residual cutaneous disease at this time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrodeviceDevice: Microdevices The microdevice is an investigational miniaturized implantable nanodose drug delivery device. It was developed as a tool with the ultimate goal to help screen several existing and investigational drugs directly within a patient's tumor to identify what drugs are the most effective for treating a patient's cancer. The microdevice releases nanodoses of several approved drugs into the tumor, and is then excised minimally invasively several days later. Other: Standard of care therapy Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which may include a skin-directed or systemic therapy | Combination product | Local treatment cohort, Systemic treatment cohort |
Primary outcome
Feasibility of analysis
Time frame: 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
Time frame: 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.
4 secondary outcomes
Safety
Time frame: through study completion, an average of 1 year
Correlation between tumor-drug response on microdevice and clinical response to systemic treatment
Time frame: through study completion, an average of 1 year
Additional biomarker identification
Time frame: through study completion, an average of 1 year
Intralesional heterogeneity assessment
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Squamous Cell Carcinoma of the Skin
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 2
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
Locally Recurrent Skin Squamous Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma
RecruitingPhase 1
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Non Small Cell Lung Cancer, Triple Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Microdevice in people with Squamous Cell Carcinoma of the Skin and Squamous Cell Carcinoma, run by Oliver Jonas 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 17 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 18 May 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of analysis (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026.