A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer
NCT ID: NCT05574101
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
34 participants
INTERVENTIONAL
2022-10-06
2026-10-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer
NCT04315701
Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer
NCT06568172
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
NCT04050436
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
NCT06585410
Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC
NCT04242173
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Cemiplimab
Participants will undergo baseline imaging, followed by two doses of neoadjuvant cemiplimab at a dose of 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days). Then, participants will receive concurrent cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) concurrently with RT to 70 Gy in 35 fractions over 7 weeks. Thereafter, participants will receive 38 weeks of cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) for a cumulative total of 12 months of cemiplimab.
Radiotherapy
Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cemiplimab
Participants will undergo baseline imaging, followed by two doses of neoadjuvant cemiplimab at a dose of 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days). Then, participants will receive concurrent cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) concurrently with RT to 70 Gy in 35 fractions over 7 weeks. Thereafter, participants will receive 38 weeks of cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) for a cumulative total of 12 months of cemiplimab.
Radiotherapy
Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mixed histology tumors that are predominantly squamous cell carcinoma are eligible
* Locally advanced primary tumor is T3-T4 and/or N+ by AJCC and/or UICC 8th edition clinical criteria
* T3-T4 primary tumor characteristics noted below:
* Non-eyelid tumor \>4 cm in maximum dimension or with bone erosion or invasion, perineural invasion of nerve 0.1 mm or larger, or invasion beyond subcutaneous fat or \>6 mm from granular layer of adjacent normal epidermis
* Eyelid tumor \>2 cm or invading adjacent ocular, orbital or facial structures
* ≥18 years old
* Unresectable or medically inoperable according to local multidisciplinary consensus for reasons such as:
* Tumor or regional lymph node metastases that has recurred despite ≥2 prior surgical procedures, with another curative resection unlikely
* Tumor or nodal disease with significant local invasion that precludes complete resection
* Tumor or nodal disease in anatomically challenging area where surgery may result in significant disfigurement or dysfunction (amputation of nose, ear, eye, digit, limb, etc)
* Medical contraindication to surgery
* Patient refusal of surgery due to anticipate morbidity
* ECOG ≤2
* Adequate bone marrow and metabolic function (by blood tests)
* Total bilirubin ≤1.5 x upper limit of normal
* Aspirate aminotransferase (AST) ≤3 x upper limit of normal
* Alanine aminotransferase (ALT) ≤3 x upper limit of normal
* Alkaline phosphatase ≤2.5 x upper limit of normal
* Serum creatinine ≤1.5 x upper limit of normal or estimated creatinine clearance \>30 mL/min according to Cockcroft-Gault formula
* Hemoglobin \>9 g/dL
* Absolute neutrophil count ≥1.5 x10\^9/L
* Platelet count ≥75 x10\^9/L
* Able to provide informed consent
* Acceptable candidate for curative intent radiotherapy and Cemiplimab immunotherapy, in opinion of radiation and medical oncologist, respectively
* Life expectancy \>18 months
Exclusion Criteria
* Iatrogenic immunosuppression (\>prednisone 10 mg/day or equivalent within 14 days of initiation of treatment)
* Women of child bearing potential unwilling or unable to use effective contraception while receiving treatment with cemiplimab and for 4 months thereafter
* Distant metastases
* Clinically significant autoimmune disease that requires iatrogenic immunosuppression
o For example, severe rheumatoid arthritis requiring disease modifying antirheumatic drugs, such as methotrexate
* Current or previous hematopoietic malignancy (leukemia, lymphoma)
* Prior allogeneic transplant of solid organ or bone marrow
* Concurrent malignancies with \>10% risk of metastasis or death within 2 years
* Prior aPD1 immunotherapy or PI3Kδ inhibitor use
* Prior radiotherapy for the cutaneous squamous cell carcinoma requiring treatment
* Other ongoing cancer therapy
o Adjuvant endocrine therapy is permitted for patients with prostate or breast cancer
* Uncontrolled HIV or infectious hepatitis (viral load detectable in patient with known infection)
* Pregnancy or breastfeeding
* Comorbid or diagnostic abnormalities within the last year that would interfere with interpretation of study results
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher Barker, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado (Data Collection Only)
Aurora, Colorado, United States
Moffitt Cancer Center (Data Collection Only)
Tampa, Florida, United States
Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States
Cleveland Clinic (Data Collection Only)
Cleveland, Ohio, United States
Fox Chase Cancer Center (Data Collection Only)
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Washington (Data Collection Only)
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Memorial Sloan Kettering Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-090
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.