Radiotherapy + Cemiplimab for Skin Cancer

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

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that Radiotherapy + Cemiplimab for Skin Cancer is an effective treatment?

The available research shows that cemiplimab, a drug approved in 2018, is effective for treating advanced cutaneous squamous cell carcinoma (CSCC), especially for patients who cannot undergo surgery or radiation. Studies have demonstrated that combining cemiplimab with radiotherapy can enhance the body's immune response against tumors. This combination has shown promising results in clinical trials, suggesting it could be a strong option for treating this type of skin cancer. ^{1 2 3 4 5}

What data supports the effectiveness of the drug cemiplimab when used with radiotherapy for skin cancer?

Cemiplimab has been shown to be effective in treating advanced cutaneous squamous cell carcinoma, a type of skin cancer, especially in patients who cannot undergo surgery or radiation alone. Additionally, combining cemiplimab with radiotherapy may enhance the body's immune response against tumors, although this specific combination has not been extensively studied in real-life settings for this type of cancer. ^{2 3 4 5 6}

What safety data exists for the treatment of Radiotherapy + Cemiplimab for Skin Cancer?

Cemiplimab, marketed as Libtayo, has been approved by the FDA for advanced cutaneous squamous cell carcinoma (CSCC) and has shown acceptable safety in clinical trials. It is a PD-1 monoclonal antibody that enhances the immune response against tumors. In phase II trials, cemiplimab demonstrated rapid antitumor efficacy with low rates of treatment discontinuation (7%) and death (3%). Common side effects and safety issues were reviewed during its approval process. However, the data primarily comes from phase II trials, and there is limited real-world data on its long-term safety and efficacy. The CASE study is a Phase IV noninterventional study aimed at evaluating the real-world safety and survivorship of patients treated with cemiplimab for advanced CSCC. ^{2 3 5 7 8}

Is the combination of radiotherapy and cemiplimab safe for treating skin cancer?

Cemiplimab, used for advanced skin cancer, has shown acceptable safety in clinical trials with low rates of treatment discontinuation and death. Common side effects include immune-related reactions, but it is generally considered safe for use in humans. ^{2 3 5 7 8}

Is the drug Cemiplimab, used with Radiotherapy, a promising treatment for skin cancer?

Yes, Cemiplimab, when used with Radiotherapy, is a promising treatment for advanced skin cancer. It has been approved for use in cases where surgery or traditional radiation isn't an option, and it works by boosting the immune system to fight cancer cells. Studies have shown that it can lead to significant and lasting responses in patients, making it a valuable new option for treating this type of cancer. ^{2 3 4 5 9}

How is the treatment of radiotherapy combined with cemiplimab unique for skin cancer?

This treatment is unique because it combines cemiplimab, an immunotherapy drug that boosts the immune system to fight cancer, with radiotherapy, which uses high-energy rays to kill cancer cells. The combination aims to create a stronger anti-cancer response than either treatment alone, especially for patients who cannot undergo surgery or curative radiation. ^{2 3 4 5 9}

Research Team

Christopher Barker, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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-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 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, 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 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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Radiotherapy and skin tumors]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Cemiplimab: First Global Approval. [2023]

4. Switzerland 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. [2023]

5. New Zealand 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. [2023]

6. Greece pubmed.ncbi.nlm.nih.gov

Skin Reaction to Cetuximab as a Criterion for Treatment Selection in Head and Neck Cancer. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Cemiplimab in advanced cutaneous squamous cell carcinoma. [2022]

8. England pubmed.ncbi.nlm.nih.gov

CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. [2020]