Recurrent Skin Squamous Cell CarcinomaPhase 2NCT04315701
A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer
A Phase 2 study testing Cemiplimab and Resection in people with Recurrent Skin Squamous Cell Carcinoma and Resectable Skin Squamous Cell Carcinoma, run by University of Southern California at 5 sites in United States.
Trial summary
This phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), and can be removed by surgery (resectable). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Skin Squamous Cell Carcinoma, Resectable Skin Squamous Cell Carcinoma, Stage I Skin Cancer
- What is being tested?
- Cemiplimab and Resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Jun 2020to 31 Dec 2027
- Phase
- Phase 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
- Histologically confirmed, cutaneous squamous cell carcinoma
- Patients must have disease that is deemed potentially resectable, at the time of the start of study, by the treating investigator. The decision to perform surgery on patients must be based on good clinical judgment. Eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed potentially resectable, resulting in free surgical margins
- Patients must have measurable disease
- Patients must have disease that is considered either: (1) high-risk localized CSCC, (2) locally recurrent CSCC, or (3) regionally advanced CSCC. The criteria specific to each of these populations is listed below
- For patients with high-risk localized CSCC, at least two of the following clinical or pathologic high-risk features must be present to be eligible:
- Clinical risk factors
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- Any tumor size > 2.0 cm in diameter
- Tumors > 1.0 cm in high risk locations, including "mask areas" (central face, eyelids, eyebrow, nose, lips [cutaneous], periorbital, chin, mandible, preauricular and postauricular skin/sulci, genitalia, hands, feet, cheek, forehead, scalp, neck and pretibial)
- Any rapidly growing and/or symptomatic tumor
- Pathologic risk factors
- Poorly differentiated histology
- Depth > 6 mm in thickness
- Acantholytic / adenoid, adenosquamous, desmoplastic, or metaplastic / carcinosarcomatous histologic subtypes
- Invasion beyond subcutaneous fat
- Perineural, lymphatic, or vascular involvement
- Patients with locally recurrent CSCC, that failed prior surgery, radiation or systemic therapy, are eligible, as long as they have measurable disease and are deemed potentially resectable by the treating investigator
- Patients with regionally advanced CSCC, including in-transit, cutaneous, subcutaneous or lymph node metastases are eligible, as long as they have measurable disease and are deemed potentially resectable by the treating investigator
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Absolute neutrophil count >= 1,000 /mcL
- Absolute lymphocyte count >= 500 / mcL
- Hemoglobin >= 8.0 g/dL
- Platelets >= 75,000/mcl
- Total bilirubin =< 1.5 x institutional upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SPGT]) =< 3 x institutional upper limit of normal
- Creatinine =< 1.8 mg/dl
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Ability to understand and the willingness to sign a written informed consent and comply with surgical resection at end of study and other study-related procedures
Who cannot join
- Metastatic disease that is unresectable. Patients with visceral metastases are not eligible. Regionally advanced disease, including in-transit, cutaneous, subcutaneous, or nodal metastases are allowed, if deemed potentially resectable by the investigator
- Prior treatment with cemiplimab or any other agent that blocks the PD-1 or PD-L1 pathway
- Prior treatment with other immune modulating agents within fewer than 4 weeks, prior to the first dose of cemiplimab. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB, OX-40, therapeutic vaccines, or cytokine therapies
- Patients must not be receiving other concomitant biologic therapy, hormonal therapy, chemotherapy, other anti-cancer therapy or any other investigational agents while on this protocol
- Radiation therapy, non-cytotoxic agents or investigational agents in the 4 weeks prior to registration
- Immunosuppressive systemic corticosteroids equivalent to prednisone 10 mg or greater in the 14 days prior to the first dose of cemiplimab
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- Any major surgery within 14 days prior to the first dose of cemiplimab. Patients must have recovered from any major complications before registration
- Active autoimmune disease requiring systemic treatment in the past 2 years (i.e. use of disease modifying agents or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment
- History of other prior malignancy in the last five years, with the exception of: adequately treated non-melanoma skin cancers (including multiple primary skin cancers), adequately treated in situ cancer, and other local tumors considered cured by local treatment (including melanoma)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cemiplimab or any other PD-1 or PD-L1 inhibitor
- 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
- Positive pregnancy test, active pregnancy or nursing / breast-feeding, due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
- History solid organ or bone marrow transplantation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Hoag Memorial Hospital
Newport Beach, California, 92663
University of Nebraska
Omaha, Nebraska, 68198
About this study
Official title: Evaluating the PD-1 Checkpoint Inhibitor, Cemiplimab, as Neoadjuvant Therapy in High Risk Localized, Locally Recurrent, and Regionally Advanced Cutaneous Squamous Cell Carcinoma: A Phase II Pilot Study
This phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the pathological partial response (PPR) rate in patients with potentially resectable cutaneous squamous cell carcinoma (CSCC) treated with neoadjuvant cemiplimab.
SECONDARY OBJECTIVES:
- To estimate the pathological complete response rate (PCR). II. To estimate the Response Evaluation Criteria in Solid Tumors (RECIST) (version [v]1.1) 9 week objective response rate (ORR).
III. To estimate the RECIST (v1.1) 12 month progression free (PFS). IV. To assess the toxicity among patients with CSCC treated with neoadjuvant cemiplimab.
EXPLORATORY OBJECTIVES:
- To evaluate tumor mutational burden (TMB) and correlate with response to PD-1 blockade therapy.
II. To evaluate PD-L1 expression on CSCC tumor cells and correlate with response to PD-1 blockade.
III. To evaluate CD8+ T cell infiltration into CSCC tumors and correlate with response to PD-1 blockade.
IV. To assess other adaptive immune resistance mechanisms in CSCC tumors.
OUTLINE:
Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection.
After completion of study treatment, patients are followed up every 3 months for 24 months.
- Conditions
- Recurrent Skin Squamous Cell Carcinoma, Resectable Skin Squamous Cell Carcinoma, Stage I Skin Cancer, Stage II Skin Cancer, Stage III Skin Cancer
- Being tested
- Cemiplimab, Resection
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabBiological
Also called Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN2810
Given IV
ResectionProcedure or surgery
Also called Surgical Resection
Undergo surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cemiplimab, surgical resection) | Experimental | Patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection. Receives: Biological: Cemiplimab; Procedure: Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed pathologic partial response
Defined by presence of < 50% malignant cells. Descriptive statistics will be used to summarize the measurements.
Measured: Up to 24 months after completion of study treatment
Secondary outcomes (4)
Pathologic complete response rate
Descriptive statistics will be used to summarize the measurements.
Measured: Up to 24 months after completion of study treatment
Objective response rate
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Descriptive statistics will be used to summarize the measurements.
Measured: At 9 weeks
Progression-free survival
Measured by RECIST v1.1. Descriptive statistics will be used to summarize the measurements.
Measured: From start of treatment to time of progression or death whichever comes first, assessed at 12 months
Incidence of toxicities
All toxicities will be summarized and graded according to maximum grade by Common Terminology Criteria for Adverse Events v4. Descriptive statistics will be used to summarize the measurements.
Measured: Up to 24 months after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start17 Jun 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Skin Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gino K In, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315701
- Sponsor's protocol ID
- 14SK-19-1
- Other IDs
- NCI-2020-01247, 14SK-19-1, P30CA014089
- Status last verified
- May 2026
- First submitted
- 17 Mar 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the PD-1 Checkpoint Inhibitor, Cemiplimab, as Neoadjuvant Therapy in High Risk Localized, Locally Recurrent, and Regionally Advanced Cutaneous Squamous Cell Carcinoma: A Phase II Pilot Study
- ClinicalTrials.gov ID
- NCT04315701
- Acronym / sponsor ID
- 14SK-19-1
- Conditions
- Recurrent Skin Squamous Cell Carcinoma, Resectable Skin Squamous Cell Carcinoma, Stage I Skin Cancer, Stage II Skin Cancer, Stage III Skin Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Mar 2020 (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 phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed description
PRIMARY OBJECTIVE:
- To assess the pathological partial response (PPR) rate in patients with potentially resectable cutaneous squamous cell carcinoma (CSCC) treated with neoadjuvant cemiplimab.
SECONDARY OBJECTIVES:
- To estimate the pathological complete response rate (PCR). II. To estimate the Response Evaluation Criteria in Solid Tumors (RECIST) (version [v]1.1) 9 week objective response rate (ORR).
III. To estimate the RECIST (v1.1) 12 month progression free (PFS). IV. To assess the toxicity among patients with CSCC treated with neoadjuvant cemiplimab.
EXPLORATORY OBJECTIVES:
- To evaluate tumor mutational burden (TMB) and correlate with response to PD-1 blockade therapy.
II. To evaluate PD-L1 expression on CSCC tumor cells and correlate with response to PD-1 blockade.
III. To evaluate CD8+ T cell infiltration into CSCC tumors and correlate with response to PD-1 blockade.
IV. To assess other adaptive immune resistance mechanisms in CSCC tumors.
OUTLINE:
Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection.
After completion of study treatment, patients are followed up every 3 months for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cemiplimab, surgical resection) | Experimental | Biological: Cemiplimab, Procedure: ResectionPatients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Histologically confirmed, cutaneous squamous cell carcinoma
- Patients must have disease that is deemed potentially resectable, at the time of the start of study, by the treating investigator. The decision to perform surgery on patients must be based on good clinical judgment. Eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed potentially resectable, resulting in free surgical margins
- Patients must have measurable disease
- Patients must have disease that is considered either: (1) high-risk localized CSCC, (2) locally recurrent CSCC, or (3) regionally advanced CSCC. The criteria specific to each of these populations is listed below
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (13 listed)
- Metastatic disease that is unresectable. Patients with visceral metastases are not eligible. Regionally advanced disease, including in-transit, cutaneous, subcutaneous, or nodal metastases are allowed, if deemed potentially resectable by the investigator
- Prior treatment with cemiplimab or any other agent that blocks the PD-1 or PD-L1 pathway
- Prior treatment with other immune modulating agents within fewer than 4 weeks, prior to the first dose of cemiplimab. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB, OX-40, therapeutic vaccines, or cytokine therapies
- Patients must not be receiving other concomitant biologic therapy, hormonal therapy, chemotherapy, other anti-cancer therapy or any other investigational agents while on this protocol
- Radiation therapy, non-cytotoxic agents or investigational agents in the 4 weeks prior to registration
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 |
|---|---|---|
| CemiplimabAlso: Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN2810Given IV | Biological | Treatment (cemiplimab, surgical resection) |
| ResectionAlso: Surgical ResectionUndergo surgical resection | Procedure or surgery | Treatment (cemiplimab, surgical resection) |
Primary outcome
Confirmed pathologic partial response
Time frame: Up to 24 months after completion of study treatment
Defined by presence of < 50% malignant cells. Descriptive statistics will be used to summarize the measurements.
4 secondary outcomes
Pathologic complete response rate
Time frame: Up to 24 months after completion of study treatment
Objective response rate
Time frame: At 9 weeks
Progression-free survival
Time frame: From start of treatment to time of progression or death whichever comes first, assessed at 12 months
Incidence of toxicities
Time frame: Up to 24 months after completion of study treatment
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 1 Jun 2026.
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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. This study is not recruiting at the moment.
Gino K In, MD principal investigator
University of Southern California
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab and Resection in people with Recurrent Skin Squamous Cell Carcinoma and Resectable Skin Squamous Cell Carcinoma, run by University of Southern California at 5 sites 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 29 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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?
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?
Confirmed pathologic partial response (time frame: Up to 24 months after completion of study treatment). 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 1 Jun 2026.