Radiotherapy + Cemiplimab for Skin Cancer

Not currently recruiting at 14 trial locations

Overseen By Christopher Barker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Immunosuppressants, Antirheumatics, aPD1, PI3Kδ

Disqualifiers: Autoimmune disease, Hematopoietic malignancy, Metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining radiation therapy with cemiplimab, an immunotherapy, effectively treats individuals with a specific type of advanced skin cancer called cutaneous squamous cell carcinoma (CSCC) that cannot be surgically removed. It targets patients whose cancer has significantly grown or spread locally, making surgery difficult or unsuitable. Eligible participants may have CSCC that has recurred despite at least two surgeries or have tumors in challenging areas where surgery would cause major complications or disfigurement. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive drugs or other ongoing cancer therapies, you may need to stop them. Please consult with the trial coordinators for specific guidance.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on certain immunosuppressive drugs or those who have had prior specific cancer treatments. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found cemiplimab to be generally safe for patients with advanced cutaneous squamous cell carcinoma (CSCC). Most patients tolerated it well, though some experienced side effects like tiredness, skin rash, or diarrhea, which are common with this type of treatment. The FDA has approved cemiplimab for treating CSCC, supporting its safety.

Research shows that radiotherapy is usually safe and well-tolerated for treating advanced skin cancers. It can cause skin irritation and tiredness, but these effects are typically temporary.

Overall, both cemiplimab and radiotherapy have been used safely to treat skin cancer, with side effects that are often manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for cutaneous squamous cell carcinoma (CSCC), which typically involve surgery and conventional chemotherapy, the combination of cemiplimab and radiotherapy offers a fresh approach. Cemiplimab is a type of immunotherapy that works by targeting and inhibiting a protein called PD-1, which helps the immune system better recognize and attack cancer cells. This is different from traditional treatments, which don't engage the immune system in the same way. Researchers are particularly excited about this combination because cemiplimab, paired with radiotherapy, may enhance the overall effectiveness of treatment, potentially leading to better outcomes for patients with locally advanced, unresectable CSCC.

What evidence suggests that the combination of radiotherapy and cemiplimab is an effective treatment for CSCC?

Research has shown that cemiplimab effectively treats advanced cutaneous squamous cell carcinoma (CSCC). Studies indicate it can reduce the risk of cancer recurrence or death by 68%. Long-term evidence supports its strong effectiveness and manageable safety in patients with advanced CSCC. Radiotherapy also proves effective for advanced CSCC, particularly for those unable to undergo surgery, and has improved survival rates, with 65% of patients surviving at least 24 months in some cases. This trial will evaluate the combination of cemiplimab and radiotherapy, offering promising options for managing locally advanced, unresectable CSCC. ^{2 3 4 6 7}

Who Is on the Research Team?

Christopher Barker, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific skin cancer (CSCC) that can't be removed by surgery. They should have a life expectancy of more than 18 months, be fit enough for radiotherapy and immunotherapy, and not have other serious health issues or ongoing cancer treatments. Pregnant or breastfeeding women are excluded.

Inclusion Criteria

My skin cancer is advanced but hasn't spread beyond the skin.

My blood tests show my bone marrow and metabolism are functioning well.

My cancer is at an advanced local stage, classified as T3-T4 or has spread to nearby lymph nodes.

Exclusion Criteria

I have or had blood cancer (like leukemia or lymphoma).

I have not taken more than 10 mg of prednisone or similar drugs daily in the last 14 days.

I have had a transplant of an organ or bone marrow from another person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive radiation therapy as part of the treatment regimen

6-8 weeks

Immunotherapy

Participants receive cemiplimab immunotherapy

up to 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Radiotherapy

Trial Overview The study tests if combining radiation therapy with an immunotherapy drug called Cemiplimab works well against advanced CSCC that cannot be surgically removed. Participants will receive both treatments to see how effective they are together.

How Is the Trial Designed?

Group I: Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC Experimental Treatment 2 Interventions

Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

Approved in European Union as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in United States as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Basal cell carcinoma (BCC)
• Non-small cell lung cancer (NSCLC)

Approved in Canada as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in Brazil as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

External radiotherapy, using kilovoltage X-rays or electrons, is generally more effective for treating skin carcinomas compared to interstitial brachytherapy, which is specifically recommended for lip and nasal vestibule tumors.

Total cutaneous electron beam radiation therapy is effective for patients with limited superficial plaques of mycosis fungoides, and while radiotherapy can achieve local control in classical Kaposi's sarcoma, it provides good palliative results in the epidemic form.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiotherapy and skin tumors]. Calitchi, E., Kirova, Y., Le Bourgeois, JP.[2019]

Cemiplimab is a PD-1 monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which is crucial for enhancing the immune response against cancer cells.

In September 2018, cemiplimab received FDA approval for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma who cannot undergo curative surgery or radiation, marking a significant advancement in cancer treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab: First Global Approval. Markham, A., Duggan, S.[2023]

Cemiplimab-rwlc (Libtayo) is an FDA-approved immunotherapy for advanced cutaneous squamous cell carcinoma (CSCC) that works by blocking the PD-1 receptor, enhancing the immune system's ability to fight tumors.

Clinical trials have shown that cemiplimab is effective in treating CSCC, although common side effects and safety issues were noted, highlighting the need for ongoing research to improve treatment outcomes and reduce toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. Ahmed, SR., Petersen, E., Patel, R., et al.[2019]

Cemiplimab, a PD-1 targeting monoclonal antibody, demonstrated an objective response rate of 45.5% in a real-life study of 33 patients with advanced cutaneous squamous cell carcinoma, confirming its efficacy as a treatment option.

The addition of radiotherapy to cemiplimab resulted in a quicker response time, with a median duration of response of 5.5 months compared to 3 months for cemiplimab alone, and did not increase adverse events, indicating a safe and effective combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Life Study of the Benefit of Concomitant Radiotherapy with Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma (cSCC): A Retrospective Cohort Study. Bailly-Caillé, B., Kottler, D., Morello, R., et al.[2023]

Cemiplimab-rwlc is a newly approved PD-1/L1 inhibitor for first-line treatment of metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK mutations, either alone or with chemotherapy.

This review highlights the differences in patient populations studied for cemiplimab compared to other treatments, emphasizing its role in expanding options for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. Ahn, J., Nagasaka, M.[2023]

Cemiplimab (Libtayo®) is the first approved immunotherapy for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who cannot undergo surgery or radiotherapy, showing a clinically significant objective response rate in the phase II EMPOWER-CSCC 1 trial.

The treatment has a durable effect, with the median duration of response and overall survival not yet reached, and it has an acceptable safety profile, with manageable immune-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. Lee, A., Duggan, S., Deeks, ED.[2020]

Cemiplimab is the first FDA-approved treatment for patients with advanced cutaneous squamous cell carcinoma (CSCC) who cannot undergo curative surgery or radiation, demonstrating rapid and substantial antitumor efficacy in phase II clinical trials.

The treatment has an acceptable safety profile, with low rates of treatment discontinuation (7%) and death (3%), although current recommendations are based mainly on phase II data due to the lack of an approved comparator agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab in advanced cutaneous squamous cell carcinoma. Naik, PP.[2022]

Cemiplimab-rwlc is the first systemic treatment approved by the US FDA for patients with advanced cutaneous squamous cell carcinoma (CSCC) who cannot undergo curative surgery or radiation, highlighting its significance in treating this aggressive cancer.

The CASE study is a Phase IV, noninterventional study designed to gather real-world data on the clinical characteristics and survivorship of patients receiving cemiplimab, aiming to enhance understanding of its effectiveness and patient outcomes in everyday clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma. Migden, MR., Chandra, S., Rabinowits, G., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11268751/

Real-World Treatment Patterns and Outcomes of Cemiplimab ... These findings confirm the effectiveness of cemiplimab among a heterogenous, real-world advanced CSCC patient population and substantiate the ...

2. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-phase-3-data-adjuvant-treatment-post

Libtayo® (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).

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.9533

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/ ...

4. libtayohcp.com libtayohcp.com/cscc/efficacy/response-duration

Up to 5 years of Long-term follow-up data Phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC): follow-up at 43 months. Poster presented at: 10th World Congress ...

5. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma

FDA approves cemiplimab-rwlc for adjuvant treatment ... FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma ... The major efficacy outcome measure was disease ...

6. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-rwlc-approved-us-first-and-only

Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First ... Approval based on pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772611824002611

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.