Cutaneous Squamous Cell CarcinomaEarly Phase 1NCT07869823
Cemiplimab and Quad Shot Radiation for Cutaneous Squamous Cell Carcinoma in the Head and Neck
A Early Phase 1 study testing Cemiplimab and Radiation Therapy in people with Cutaneous Squamous Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the combination of the drug cemiplimab along with a short course of radiation therapy called Quad Shot can be successfully given in several rounds to elderly or frail patients with head and neck skin cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- Cemiplimab and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2029
- 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
- Locally advanced squamous cell carcinoma of the skin arising from the head and neck region.
- Patients who have had prior treatment of a localized skin primary and now present with nodal recurrence or unresectable local recurrence are considered eligible as long as the recurrent disease has not been previously treated with radiation therapy
- No prior systemic therapy including chemotherapy, targeted therapy or immunotherapy.
- Deemed unfit for definitive curative intent treatment with surgery or radiation therapy due to one of the following criteria:
- ECOG Performance status 3 or 4;
- significant co-morbid medical conditions.
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- frailty due to advanced age (must be > 70 years of age if using this criterion only).
- At least one measurable lesion as defined by RECIST 1.1.
- Tumor tissue available for correlative-sequencing (tumor tissue from bony metastasis is not suitable; however, archival tissue is acceptable). A minimum of 6 cores from initial lymph node biopsy is strongly encouraged.
- Adequate organ function as defined by:
- Absolute neutrophil count >= 1,000/ul
- Platelets >= 75,000/ul
- Hemoglobin >= 7 g/dL (without requirement for transfusion in prior 4 weeks)
- Calculated serum creatinine clearance > 20 mL/min by the Cockcroft-Gault formula (clearance < 20mL/min will be allowed if patient is on a stable dialysis regimen)
- Total bilirubin =< 1.5 X upper normal limit (UNL) (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
- Aspartate aminotransferase (AST) =< 3.0 X UNL
- Alanine aminotransferase (ALT) =< 3.0 X UN
- Willing and able to sign informed consent.
- Male or female ≥ 18 years of age at the time of informed consent.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during screening and prior to receiving first dose of protocol-indicated treatment.
- Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal.
- Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes.
- Women of childbearing potential must agree to use of contraceptives to prevent pregnancy.
Who cannot join
- Prior systemic therapy for locally advanced cutaneous carcinoma of the head and neck (LACCHN)
- Metastatic disease outside of the head and neck.
- Prior treatment with checkpoint inhibitor therapy.
- Planned re-irradiation: If disease is recurrent in a site previously treated with radiation, the patient will not be considered for study.
- Active wound and/or infection overlaying the head or neck region that would prohibit safe radiation delivery.
- Active second malignancy. Second malignancies that have been either cured or definitively treated and in remission are acceptable for inclusion.
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- Presence of cardiovascular disease, as defined by either:
- New York Heart Association heart failure classifications of Class II, III, or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication.
- Transient ischemic attack or stroke within 1 year
- Exclusions relating to infection or immunodeficiency including:
- Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study medication. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are not excluded.
- Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
- Note: The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.
- Any infection requiring hospitalization or treatment with IV anti- infectives within 2 weeks of first dose of study medication
- Uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent). Participants with known controlled HIV infection (undetectable viral load on HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen are eligible. For these participants monitoring will be performed per local standards.
- Prior recipient of organ transplantation.
- Exclusions relating to vaccines including:
- Receipt of a live vaccine within 4 weeks of start of study medication
- Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.
- Exclusions relating to hypersensitivity including:
- Known hypersensitivity to the active substances or to any of the excipients.
- Exclusions and information relating to pregnancy/contraception:
- WOCBP* and men** who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:
- Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;
- Intrauterine device; intrauterine hormone-releasing system;
- Bilateral tubal occlusion/ligation;
- Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and/or
- Sexual abstinence Pregnancy testing and contraception are required for WOCBP. Pregnancy testing and contraception are not required for women who are postmenopausal or permanently sterile.
- WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documents hysterectomy or tubal ligation.
- Male participants: A male participant will be excluded from the study if that participant does not agree to use condoms or practice sexual abstinence†‡, unless vasectomized, prior to the initial dose/start of study medication, during the study, and for at least 6 months after the last dose. Sperm donation is also prohibited during the same period. Vasectomy success must be confirmed by semen analysis.
- Prohibited medications Participants must not receive live vaccines during the study. Participants using immunosuppressive doses (≥10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for physiologic corticosteroid replacement are not eligible for the study. Participants should not receive systemic corticosteroids such as hydrocortisone, prednisone, prednisolone (Solu-Medrol®) or dexamethasone (Decadron®) at any time throughout the study except as required premedication for chemotherapy or another study treatment per protocol and in the case of a life-threatening emergency and/or to treat an imAE.
- Similarly, it is recommended that participants do not receive other immunosuppressive medications (eg, methotrexate) at any time throughout the study except in the case of a life-threatening emergency and/or to treat an imAE. Other immunosuppressive medications required to treat imAEs, IRRs, or life-threatening emergencies may be used at the investigator's discretion. Investigators are allowed to treat TEAEs requiring immunosuppressive medication per standard of care which may involve medications not specifically mentioned in the protocol.
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, 1 recruiting
- Recruiting
Washington University Medical Center
St Louis, Missouri, 63110
Jennifer De Los Santos, M.D., 314-747-7236, jdelossantos@wustl.edu
Alice Y Zhou, M.D., Ph.D., 314-454-8318, alice.y.zhou@wustl.edu
About this study
Official title: Feasibility Study of Cemiplimab and Quad Shot Radiation in Elderly, Frail, or High Comorbidity Patients With Locally Advanced Cutaneous Squamous Cell Carcinomas of the Skin Arising in the Head and Neck Region
The goal of this clinical trial is to learn if the combination of the drug cemiplimab along with a short course of radiation therapy called Quad Shot can be successfully given in several rounds to elderly or frail patients with head and neck skin cancers. The main question it aims to answer is:
- Can care providers successfully deliver at least 6 rounds of cemiplimab and 3 rounds of Quad Shot radiation to patients?
Patients will:
- Be given cemiplimab every 3 weeks for a total of up to 8 doses
- Be given Quad Shot radiation (four treatments over two days) every 3 weeks for a total of up to 4 rounds
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- Cemiplimab, Radiation Therapy
- Keywords
- skin cancer, squamous cell carcinoma, cutaneous, immunotherapy, cemiplimab, radiotherapy, radiation, quad shot, Libtayo, head and neck
- Medical subject headings
- Skin Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Cemiplimab 350mg (IV) will be administered every 3 weeks for a total of eight doses or until progression or treatment related toxicity requiring discontinuation of therapy. Cemiplimab may be continued at the treating physician's discretion beyond six months for up to one year (cycle 9 to 16) for patients who achieve a partial or complete objective response and are tolerating treatment.
Radiation TherapyRadiation
Radiation therapy will be delivered using a Quad Shot technique (two treatments per day for two days). Quad Shots will be repeated every three weeks for up to four consecutive cycles. The total planned radiation dose is 59.2 Gy. Patients achieving a complete clinical and radiographic response following the third Quad Shot may discontinue radiation after the third Quad Shot (44.4 Gy).
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab and radiation | Experimental | Not described Receives: Drug: Cemiplimab; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as measured by the percentage of subjects receiving at least 6 planned doses of cemiplimab and at least 3 "Quad Shots"
The treatment will be deemed feasible if >80% of patients responding to therapy are able to complete at least six planned doses of cemiplimab and >75% of patients responding to therapy are able to complete at least three "Quad Shots".
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 posted13 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869823
- Sponsor's protocol ID
- 260554
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Trial sponsored by Regeneron
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Cemiplimab and Quad Shot Radiation in Elderly, Frail, or High Comorbidity Patients With Locally Advanced Cutaneous Squamous Cell Carcinomas of the Skin Arising in the Head and Neck Region
- ClinicalTrials.gov ID
- NCT07869823
- Acronym / sponsor ID
- 260554
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Keywords
- skin cancer, squamous cell carcinoma, cutaneous, immunotherapy, cemiplimab, radiotherapy, radiation, quad shot
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 13 Oct 2026 (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.
The goal of this clinical trial is to learn if the combination of the drug cemiplimab along with a short course of radiation therapy called Quad Shot can be successfully given in several rounds to elderly or frail patients with head and neck skin cancers. The main question it aims to answer is:
- Can care providers successfully deliver at least 6 rounds of cemiplimab and 3 rounds of Quad Shot radiation to patients?
Patients will:
- Be given cemiplimab every 3 weeks for a total of up to 8 doses
- Be given Quad Shot radiation (four treatments over two days) every 3 weeks for a total of up to 4 rounds
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab and radiation | Experimental | Drug: Cemiplimab, Radiation: Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Locally advanced squamous cell carcinoma of the skin arising from the head and neck region.
- Patients who have had prior treatment of a localized skin primary and now present with nodal recurrence or unresectable local recurrence are considered eligible as long as the recurrent disease has not been previously treated with radiation therapy
- No prior systemic therapy including chemotherapy, targeted therapy or immunotherapy.
- Deemed unfit for definitive curative intent treatment with surgery or radiation therapy due to one of the following criteria:
- At least one measurable lesion as defined by RECIST 1.1.
Key exclusion criteria (33 listed)
- Prior systemic therapy for locally advanced cutaneous carcinoma of the head and neck (LACCHN)
- Metastatic disease outside of the head and neck.
- Prior treatment with checkpoint inhibitor therapy.
- Planned re-irradiation: If disease is recurrent in a site previously treated with radiation, the patient will not be considered for study.
- Active wound and/or infection overlaying the head or neck region that would prohibit safe radiation delivery.
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 |
|---|---|---|
| CemiplimabCemiplimab 350mg (IV) will be administered every 3 weeks for a total of eight doses or until progression or treatment related toxicity requiring discontinuation of therapy. Cemiplimab may be continued at the treating physician's discretion beyond six months for up to one year (cycle 9 to 16) for patients who achieve a partial or complete objective response and are tolerating treatment. | Drug | Cemiplimab and radiation |
| Radiation TherapyRadiation therapy will be delivered using a Quad Shot technique (two treatments per day for two days). Quad Shots will be repeated every three weeks for up to four consecutive cycles. The total planned radiation dose is 59.2 Gy. Patients achieving a complete clinical and radiographic response following the third Quad Shot may discontinue radiation after the third Quad Shot (44.4 Gy). | Radiation | Cemiplimab and radiation |
Primary outcome
Feasibility, as measured by the percentage of subjects receiving at least 6 planned doses of cemiplimab and at least 3 "Quad Shots"
Time frame: through study completion, an average of 1 year
The treatment will be deemed feasible if >80% of patients responding to therapy are able to complete at least six planned doses of cemiplimab and >75% of patients responding to therapy are able to complete at least three "Quad Shots".
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 13 Oct 2026.
- Individual participant dataSharing planned: No. Trial sponsored by Regeneron
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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.
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 Cemiplimab and Radiation Therapy in people with Cutaneous Squamous Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center 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 23 inclusion and 33 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 13 Oct 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?
Contact Barbara Murphy, M.D. (615-936-8422, barbara.murphy@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as measured by the percentage of subjects receiving at least 6 planned doses of cemiplimab and at least 3 "Quad Shots" (time frame: through study completion, an average of 1 year). 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 13 Oct 2026.