Now Enrolling! Refer your patients! |
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A Phase 3 Randomized Study of Intralesional Cemiplimab versus Primary Surgery in Participants with Early Stage Cutaneous Squamous Cell Carcinoma (CSCC) |
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This phase 3 randomized clinical trial evaluates the effectiveness and safety of intralesional cemiplimab—an immune checkpoint inhibitor targeting PD-1—compared to Mohs surgery in patients with early-stage cutaneous squamous cell carcinoma (CSCC). The study targets individuals with lesions measuring between 1–2 cm on the head, neck, hand, or pre-tibial area. The trial aims to determine whether cemiplimab, when injected directly into the tumor, can be a viable, less invasive alternative to surgery by assessing its tumor response and side effect profile.
Enrollment Criteria:
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Must have a confirmed diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) (punch biopsy preferred)
- Must have 1 - 2 cm of residual viable tumor (i.e. all tumor cannot be removed via shave biopsy)
- Excluded if diagnosed with non-invasive forms of CSCC
- Excluded if there is a significant history of autoimmune disease, transplantation, or hematologic malignancies
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The Phase 3 C-POST trial investigated the efficacy of Libtayo® (cemiplimab), a PD-1 inhibitor, as adjuvant therapy for patients with high-risk cutaneous squamous cell carcinoma (CSCC) following surgery. Involving 415 patients, the study showed that Libtayo significantly improved disease-free survival (DFS), reducing the risk of recurrence or death by 68% compared to placebo. With no currently approved adjuvant treatments for this condition, these results suggest that Libtayo may offer a new standard of care in preventing cancer recurrence for high-risk CSCC patients.
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In this cross-sectional study of 61 307 participants (54 554 nonveterans and 6753 veterans) from the National Health and Nutrition Examination Survey, veterans were found to have higher odds of having a skin cancer history compared with nonveterans. The findings of this study suggest that US veterans may be at an increased risk of developing various dermatologic conditions compared with nonveterans and can help inform public health measures aimed at improving prevention in this patient population.
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For surgical or cutaneous oncology referrals, please email skincancer@mfa.gwu.edu with relevant patient information (PHI secure). For patient inquires or appointments, please call Allison Moradel, Cutaneous Oncology program coordinator, at 202-741-2829.
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