Metastatic Skin Squamous Cell CarcinomaPhase 1NCT04428671
Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer
A Phase 1 study testing Cemiplimab, Radiation Therapy and Therapeutic Conventional Surgery in people with Metastatic Skin Squamous Cell Carcinoma and Recurrent Skin Squamous Cell Carcinoma, run by Emory University at 1 site in United States.
Trial summary
This phase I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Skin Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma
- What is being tested?
- Cemiplimab, Radiation Therapy and Therapeutic Conventional Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 1 Oct 2031
- Phase
- 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
- Patient must have a known diagnosis of high risk cSCC defined by the following criteria:
- Nodal disease with extracapsular extension (ECE) and at least one node >= 20 mm on the surgical pathology report
- In-transit metastases (ITM) defined as skin or subcutaneous metastases that are > 2 cm from the primary lesion but are not beyond the regional nodal basin
- T4 lesion for head and neck CSCC
- Perineural invasion (PNI), defined as clinical and/or radiologic involvement of named nerves
- Recurrent CSCC, defined as CSCC that arises within the area of the previously resected tumor, or at least one of the following additional features:
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- >= N2b disease associated with the recurrent lesion
- Nominal >= T3 (recurrent lesion >= 4 cm in diameter or minor bone erosion or deep invasion > 6 mm measured from the granular layer of normal adjacent epithelium)
- Poorly differentiated histology and >= 20 mm diameter of recurrent lesion. The recurrent lesion must be documented to be within the area of the previously resected CSCC by radial measurement of the greatest radius of the final defect, measured from the estimated center of the original surgical wound
- Cancer confirmed to be surgically resectable, with surgery evaluation with planned prior to resection
- No prior systemic immunotherapy, no prior anti-PD1 therapy
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1
- Hemoglobin >= 9.0 g/dl (within 28 days of cycle 1 day 1)
- Absolute neutrophil count (ANC) >= 1,500/mcL (within 28 days of cycle 1 day 1)
- Platelets >= 100,000/mcL (within 28 days of cycle 1 day 1)
- Total bilirubin =<1.5 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Albumin >= 3.0 g/dL (within 28 days of cycle 1 day 1)
- Serum creatinine =< 1.5 x ULN (or calculated creatinine clearance of >= 50 mL/min using Cockcroft-Gault formula) (within 28 days of cycle 1 day 1)
- International normalized ratio (INR) =< 1.5 (within 28 days of cycle 1 day 1)
- Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level < 1.1U/mL are allowed on the trial
- Clinically significant toxic effect(s) of the most recent prior anti-cancer therapy must be grade 1 or resolved (except alopecia and sensory neuropathy); patients with grade 2 adrenal insufficiency related to prior anti-cancer therapy (defined as requiring medical intervention, such as concomitant steroids) or grade 2 hypothyroidism (defined as requiring hormone replacement therapy) may be enrolled provided that clinical symptoms are adequately controlled and the daily dose is 10 mg or less of prednisone or equivalent. If the patient received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications from the intervention
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- The effects of cemiplimab on the developing human fetus are unknown. For this reason female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
- FCBP and men must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study participation and for at least 6 months following study drug discontinuation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. A female of childbearing potential (FCBP) is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least 12 consecutive months (if age >= 55 years); if the female subject is < 55 years and she has been naturally postmenopausal for >= 1 year her reproductive status has to be verified by additional lab tests (< 20 estradiol OR estradiol < 40 with follicle stimulating hormone [FSH] > 40 in women not on estrogen replacement therapy)
- Patients must agree not to donate blood, sperm/ova while taking protocol therapy and for at least 6 months after stopping treatment
- Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
Who cannot join
- Determined not to be a surgical candidate due to medical co-morbidities or extent of disease
- Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
- Prior organ allograft or allogeneic bone marrow transplantation
- Subjects with active or history of immune mediated pneumonitis, colitis, hepatitis, nephritis, or skin reactions as these patients may be at increased risk for developing immune therapy-induced exacerbation or recurrence of their immune mediated disease, potentially delaying surgery
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- Women who are pregnant or lactating
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- Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
- Clinical evidence of bleeding diathesis or coagulopathy
- Subjects with a history of severe allergic reactions
- Patients with prior malignancies, are eligible if they have been disease free for > 3 years
- Patients with prior low-risk non-melanoma skin cancers and in situ carcinomas are eligible provided there was complete removal
- Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Non-oncology vaccines within 28 days prior to starting treatment
- Prisoners and subjects who are compulsory detained
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Pilot Study of Neoadjuvant/Adjuvant Cemiplimab for High Risk Cutaneous Squamous Cell Carcinoma
This phase I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. 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. Giving cemiplimab before surgery may improve risk of the cancer returning in patients with high risk cutaneous squamous cell cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To establish the pathologic response rate of neoadjuvant cemiplimab in cutaneous squamous cell carcinoma (cSCC).
SECONDARY OBJECTIVES:
- To document the local recurrence rate of high-risk cSCC treated with adjuvant cemiplimab.
II. To document the systemic recurrence rate of high-risk cSCC treated with adjuvant cemiplimab.
III. To document the 6-month, 12-month, 2-year overall survival (OS), recurrence-free survival (RFS) for patients with high risk cSCC.
TERTIARY/EXPLORATORY OBJECTIVE:
- To evaluate the immune profile of fresh tumor tissue, blood in patients with cSCC treated with cemiplimab.
OUTLINE:
NEOADJUVANT PHASE: Prior to standard of care surgery, patients receive cemiplimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
ADJUVANT PHASE: Within 2-6 weeks after completion of standard of care radiation therapy (or surgery if no radiation therapy), patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 2 years, every 6 months for the next 3 years, and then annually for up to 10 years.
- Being tested
- Cemiplimab, Radiation Therapy, Therapeutic Conventional Surgery
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
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo standard of care radiation therapy
Therapeutic Conventional SurgeryProcedure or surgery
Undergo standard of care surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cemiplimab) | Experimental | NEOADJUVANT PHASE: Prior to standard of care surgery, patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
ADJUVANT PHASE: Within 2-6 weeks after standard of care radiation therapy (or surgery if no radiation therapy), patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Receives: Biological: Cemiplimab; Radiation: Radiation Therapy; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic response rate
Defined as the number of complete and partial responses divided by the total number of patients, as assessed by pathology. Pathological complete response (pCR) (no viable tumor) or pathological partial response (pPR) (less than 50% viable tumor) as well as near pCR (less than 10% viable tumor) in the tumor bed will be documented by pathology from the resection specimen. Pathologic response rate will be summarized using frequency and percentage, and a 95% exact confidence interval will be reported using the Clopper-Pearson method.
Measured: From screening up to 10 years post-treatment
Secondary outcomes (4)
Time to local recurrence
Local recurrence-free survival will be estimated using the Kaplan-Meier method.
Measured: From screening to local recurrence, death, or last known follow-up, assessed up to 10 years post-treatment
Time to systemic recurrence
Systemic recurrence-free survival will be estimated using the Kaplan-Meier method.
Measured: From screening to systemic recurrence, death, or last known follow-up, assessed up to 10 years post-treatment
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method. 6-month, 12-month, and 24-month OS estimates will be reported along with 95% confidence intervals.
Measured: From screening to death from any cause or last known follow-up, assessed up to 2 years post-treatment
Recurrence-free survival (RFS)
RFS will be estimated using the Kaplan-Meier method. 6-month, 12-month, and 24-month RFS estimates will be reported along with 95% confidence intervals.
Measured: From screening to recurrence, death, or last known follow-up, assessed up to 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 May 2020
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Skin Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael Lowe, Emory University
- Investigators
- Michael Lowe, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428671
- Sponsor's protocol ID
- IRB00115160
- Other IDs
- NCI-2019-07373, IRB00115160, Winship4851-19, P30CA138292
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2020
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Neoadjuvant/Adjuvant Cemiplimab for High Risk Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04428671
- Acronym / sponsor ID
- IRB00115160
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 11 Jun 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 I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. 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. Giving cemiplimab before surgery may improve risk of the cancer returning in patients with high risk cutaneous squamous cell cancer.
Detailed description
PRIMARY OBJECTIVE:
- To establish the pathologic response rate of neoadjuvant cemiplimab in cutaneous squamous cell carcinoma (cSCC).
SECONDARY OBJECTIVES:
- To document the local recurrence rate of high-risk cSCC treated with adjuvant cemiplimab.
II. To document the systemic recurrence rate of high-risk cSCC treated with adjuvant cemiplimab.
III. To document the 6-month, 12-month, 2-year overall survival (OS), recurrence-free survival (RFS) for patients with high risk cSCC.
TERTIARY/EXPLORATORY OBJECTIVE:
- To evaluate the immune profile of fresh tumor tissue, blood in patients with cSCC treated with cemiplimab.
OUTLINE:
NEOADJUVANT PHASE: Prior to standard of care surgery, patients receive cemiplimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
ADJUVANT PHASE: Within 2-6 weeks after completion of standard of care radiation therapy (or surgery if no radiation therapy), patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 2 years, every 6 months for the next 3 years, and then annually for up to 10 years.
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) | Experimental | Biological: Cemiplimab, Radiation: Radiation Therapy, Procedure: Therapeutic Conventional SurgeryNEOADJUVANT PHASE: Prior to standard of care surgery, patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. ADJUVANT PHASE: Within 2-6 weeks after standard of care radiation therapy (or surgery if no radiation therapy), patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Patient must have a known diagnosis of high risk cSCC defined by the following criteria:
- Cancer confirmed to be surgically resectable, with surgery evaluation with planned prior to resection
- No prior systemic immunotherapy, no prior anti-PD1 therapy
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1
- Hemoglobin >= 9.0 g/dl (within 28 days of cycle 1 day 1)
Key exclusion criteria (16 listed)
- Determined not to be a surgical candidate due to medical co-morbidities or extent of disease
- Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
- Prior organ allograft or allogeneic bone marrow transplantation
- Subjects with active or history of immune mediated pneumonitis, colitis, hepatitis, nephritis, or skin reactions as these patients may be at increased risk for developing immune therapy-induced exacerbation or recurrence of their immune mediated disease, potentially delaying surgery
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
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) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, IrradiationUndergo standard of care radiation therapy | Radiation | Treatment (cemiplimab) |
| Therapeutic Conventional SurgeryUndergo standard of care surgery | Procedure or surgery | Treatment (cemiplimab) |
Primary outcome
Pathologic response rate
Time frame: From screening up to 10 years post-treatment
Defined as the number of complete and partial responses divided by the total number of patients, as assessed by pathology. Pathological complete response (pCR) (no viable tumor) or pathological partial response (pPR) (less than 50% viable tumor) as well as near pCR (less than 10% viable tumor) in the tumor bed will be documented by pathology from the resection specimen. Pathologic response rate will be summarized using frequency and percentage, and a 95% exact confidence interval will be reported using the Clopper-Pearson method.
4 secondary outcomes
Time to local recurrence
Time frame: From screening to local recurrence, death, or last known follow-up, assessed up to 10 years post-treatment
Time to systemic recurrence
Time frame: From screening to systemic recurrence, death, or last known follow-up, assessed up to 10 years post-treatment
Overall survival (OS)
Time frame: From screening to death from any cause or last known follow-up, assessed up to 2 years post-treatment
Recurrence-free survival (RFS)
Time frame: From screening to recurrence, death, or last known follow-up, assessed up to 2 years post-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 14 Sep 2026.
- Individual participant dataSharing planned: No. Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.
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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.
Michael Lowe, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cemiplimab, Radiation Therapy and Therapeutic Conventional Surgery in people with Metastatic Skin Squamous Cell Carcinoma and Recurrent Skin Squamous Cell Carcinoma, run by Emory University 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 28 inclusion and 16 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 14 Sep 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?
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.
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?
Pathologic response rate (time frame: From screening up to 10 years post-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 14 Sep 2026.