Status and phase
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About
The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Biopsy proven cutaneous squamous cell carcinoma which is locally advanced
T3-T4 primary tumor characteristics noted below:
≥18 years old
Unresectable or medically inoperable according to local multidisciplinary consensus for reasons such as:
ECOG ≤2
Adequate bone marrow and metabolic function (by blood tests)
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
Primary tumor originating on the mucosal (non-hair bearing) lip or nose, anogenital (penis, scrotum, vulva, perianal) area
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
Primary purpose
Allocation
Interventional model
Masking
34 participants in 1 patient group
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Central trial contact
Lara Dunn, MD; Christopher Barker, MD
Data sourced from clinicaltrials.gov
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