Cemiplimab for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called cemiplimab to determine its effectiveness in treating early-stage cutaneous squamous cell carcinoma (CSCC). Cemiplimab aids the immune system in fighting cancer cells by targeting a specific protein on immune cells. Researchers aim to compare the effectiveness of cemiplimab to surgery and assess its potential side effects. This trial may suit individuals with CSCC tumors between 1 to 2 cm in size on the head, neck, hands, or lower legs who qualify for surgical removal. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that cemiplimab is likely to be safe for humans?
Research has shown that cemiplimab is generally safe for people. Studies have found it to be well-tolerated in patients with various types of advanced skin cancer. Common side effects include fatigue, rash, and diarrhea, but these are usually manageable. Cemiplimab is already a preferred treatment in the U.S. for severe squamous cell carcinoma when other treatments fail, providing extensive safety information. While this study examines its effects on early-stage skin cancer, the safety record for more advanced cases remains strong.12345
Why do researchers think this study treatment might be promising?
Cemiplimab is unique because it targets the PD-1 receptor on immune cells, enhancing the body's ability to fight skin cancer. Unlike traditional treatments like surgery, radiation, or chemotherapy, which can have broad effects on the body, cemiplimab is a type of immunotherapy that specifically boosts the immune system to attack cancer cells. Researchers are excited about cemiplimab because it offers a more targeted approach, potentially leading to fewer side effects and better outcomes for patients with skin cancer.
What evidence suggests that cemiplimab might be an effective treatment for skin cancer?
Research has shown that cemiplimab effectively treats cutaneous squamous cell carcinoma (CSCC). Studies indicate that patients taking cemiplimab had a 68% lower risk of cancer recurrence or death. Another study found that nearly half of the patients experienced tumor reduction or disappearance. In this trial, participants in the experimental arm will receive cemiplimab, which typically has manageable side effects, making it a promising treatment option. These findings suggest that cemiplimab could serve as a strong alternative to surgery for early-stage CSCC.12467
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
Adults with early-stage cutaneous squamous cell carcinoma (CSCC) that's between 1 and 2 cm in size, located on the head, neck, hand, or shin. Candidates should be fit for surgery and have good liver, kidney, and bone marrow function. Those who are planned to undergo surgical excision without margin control cannot participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intralesional cemiplimab or undergo primary surgery for early-stage cutaneous squamous cell carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
Trial Overview
The trial is testing cemiplimab injected directly into CSCC lesions versus standard surgical treatment. Cemiplimab is an immunotherapy drug that targets PD-1 proteins on immune cells to help destroy cancer cells.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Investigational treatment
Standard of care treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
CemiplimAb-rwlc survivorship and epidemiology (CASE)
The interim results of this Phase IV study demonstrate robust effectiveness and a generally manageable safety profile of cemiplimab in patients with laCSCC/ ...
Real-World Treatment Patterns and Outcomes of Cemiplimab ...
Most cases of CSCC are cured by surgery/radiation, but an estimated 1% to 5% of patients will develop advanced disease, which is associated ...
3.
newsroom.regeneron.com
newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-phase-3-data-adjuvant-treatment-postLibtayo® (cemiplimab) Phase 3 Data in the Adjuvant ...
Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p<0.0001).
Efficacy and safety of cemiplimab in cutaneous squamous ...
Cemiplimab showed promise in aggressive squamous cell carcinoma from chronic wound. Median progression-free survival was 6.1 months with a 47% response rate.
Efficacy of Neoadjuvant Cemiplimab Treatment for ...
Neoadjuvant use of Cemiplimab is emerging as a promising and potentially practice-changing strategy in the management of resectable cutaneous squamous cell ...
Current Efficacy and Safety and Survival Outcomes of ...
Real-world data on tolerability and clinical response of cemiplimab in patients with advanced cutaneous squamous cell carcinoma: a retrospective, multicentre ...
Cemiplimab in locally advanced or metastatic cutaneous ...
Cemiplimab proved highly effective and safe in this real-world cohort of patients with laCSCC or mCSCC, confirming its therapeutic value in the ...
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