Cemiplimab for Cutaneous T-Cell Lymphoma

(BIOSELECT Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AHS Cancer Control Alberta

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunodeficiency, Hepatitis, Autoimmune, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Up to 51 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cemiplimab, an immune therapy, benefits people with advanced mycosis fungoides, a challenging type of skin lymphoma. Researchers seek to discover if this treatment can shrink tumors in patients who haven't responded to other therapies. It suits those diagnosed with mycosis fungoides, particularly if previous treatments have been unsuccessful. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are on immunosuppressive agents or systemic corticosteroids, you may need to stop them at least 30 days before starting the trial.

Is there any evidence suggesting that cemiplimab is likely to be safe for humans?

Research has shown that cemiplimab has been tested in people with cutaneous squamous cell carcinoma (CSCC). In these studies, cemiplimab was generally safe, with most people tolerating the treatment well. However, side effects such as tiredness, skin rash, and diarrhea occurred in more than 10% of patients.

Cemiplimab is already FDA-approved for treating CSCC, indicating its safety for this condition, even though it is being tested for a different type of cancer in this trial.

Some real-world studies found that more people stopped treatment due to side effects compared to earlier studies. This suggests that while cemiplimab is usually well-tolerated, it might cause more serious reactions in some cases. Prospective trial participants should discuss potential risks with their doctor to make an informed decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Cemiplimab is unique because it is a monoclonal antibody that targets the PD-1 pathway, which is a novel approach for treating cutaneous T-cell lymphoma. Unlike the standard treatments that often involve chemotherapy or radiation, cemiplimab works by enhancing the immune system's ability to fight cancer cells. Researchers are excited about cemiplimab because it has the potential to offer a more targeted therapy with possibly fewer side effects, and it could provide a new option for patients who have not responded well to existing treatments.

What evidence suggests that cemiplimab might be an effective treatment for cutaneous T-cell lymphoma?

Research has shown that cemiplimab effectively treats other skin cancers, such as advanced cutaneous squamous cell carcinoma (CSCC). In these cases, many patients experienced tumor shrinkage. Cemiplimab aids the immune system in identifying and attacking cancer cells, which suggests it might work for mycosis fungoides (MF), a type of skin lymphoma. Patients with similar conditions have responded well to cemiplimab. Although specific results for MF are still under study, the drug's success in related cancers is encouraging. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Adults with advanced cutaneous T-cell lymphoma (mycosis fungoides) who have not responded to at least one prior therapy can join this trial. They must be able to consent, follow the study plan, and use effective birth control if of childbearing potential. People with certain organ dysfunctions or those taking immunosuppressants cannot participate.

Inclusion Criteria

I have tried at least one treatment before that didn't work.

My skin cancer (mycosis fungoides) is confirmed by a specialized board.

My organ functions are within normal ranges.

Exclusion Criteria

I have recently used drugs that weaken my immune system.

I need radiation therapy along with other treatments.

Psychiatric or substance abuse disorders that would interfere with trial cooperation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive cemiplimab 350 mg intravenously every 21 days

Up to 51 weeks

1 visit every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

99 weeks

Regular visits as per study protocol

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab

Trial Overview The trial is testing cemiplimab's effectiveness in treating mycosis fungoides after other treatments have failed. It aims to see how well patients respond by measuring the reduction in their skin tumors.

How Is the Trial Designed?

Group I: Cemiplimab Experimental Treatment 1 Intervention

Study treatment includes administration of cemiplimab 350 mg intravenous every 21 days (+/﹣ 3 days)

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?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Published Research Related to This Trial

The collaboration between dermatologists and oncologists has led to the establishment of supportive oncodermatology clinics, which focus on managing skin toxicities associated with targeted therapies for blood cancers.

A systematic review of various targeted therapies revealed distinct cutaneous adverse event profiles, emphasizing the need for early diagnosis and management to enhance treatment tolerability and patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous Adverse Events of Targeted Therapies for Hematolymphoid Malignancies. Ransohoff, JD., Kwong, BY.[2018]

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 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]

In a study of 118 patients with cutaneous T-cell lymphomas (CTCL), including mycosis fungoides (MF) and Sézary syndrome (SS), the overall survival for MF patients was 17.7 years, while SS patients had a median survival of 3.5 years, indicating significant differences in outcomes based on the type of CTCL.

The most common treatments for MF included low-dose methotrexate and interferon-alpha, while SS patients often received bexarotene and extracorporeal photopheresis, highlighting the need for more innovative therapies to be integrated into earlier treatment lines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of 118 Patients With Cutaneous T-Cell Lymphomas: A Single-Center Experience. Polgárová, K., Polívka, J., Kodet, O., et al.[2022]

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]

In a study of 11 patients with cutaneous T-cell lymphoma (CTCL), 90.9% showed significant improvement in their skin lesions after treatment with oral alitretinoin, with an average response time of 2.5 months.

Alitretinoin was generally well tolerated, with only a few patients experiencing mild side effects, suggesting it could be a promising treatment option for CTCL with a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of cutaneous T-cell lymphoma with oral alitretinoin. Kapser, C., Herzinger, T., Ruzicka, T., et al.[2018]

Cutaneous T-cell lymphomas (CTCL), particularly Mycosis fungoides (MF) and cutaneous CD30+ lymphoproliferative disorders, account for 80% of CTCL cases, and their treatment varies significantly based on disease stage, with early-stage therapies focusing on skin-directed treatments and advanced stages requiring systemic therapies.

Novel targeted therapies, such as mogamulizumab and brentuximab vedotin, are important for treating CTCL and highlight the role of biomarkers like CD30 in both diagnosis and therapy, improving treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous T-cell lymphomas-An update 2021. Kempf, W., Mitteldorf, C.[2021]

Recent advancements in the understanding of cutaneous T-cell lymphomas (CTCL) have led to the identification of new therapeutic targets, including monoclonal antibody therapies like brentuximab vedotin and mogamulizumab, which have received FDA approvals for specific CTCL subtypes.

Current treatments for early-stage CTCL primarily involve skin-directed therapies, but there is a lack of long-term curative options for advanced disease, highlighting the importance of ongoing research into new therapies such as immune checkpoint inhibitors and additional monoclonal antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Existing and Emerging Therapies for Cutaneous T-Cell Lymphoma. Van-de-Velde, V., Zhou, Y.[2019]

Citations

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

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 with ...

2. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/updated-libtayor-cemiplimab-rwlc-results-reinforce-durable-and

Updated Libtayo® (cemiplimab-rwlc) Results Reinforce ... Updated Libtayo® (cemiplimab-rwlc) Results Reinforce Durable and Substantial Response Rates in Advanced Cutaneous Squamous Cell Carcinoma ; Partial response rate ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0959804921005360

Real world data of cemiplimab in locally advanced and ... The post-surgery disease-free survival rate at 5 years exceed 90%; however, less than 5% of the patients develop disease recurrence or progression, mainly ...

4. mdpi.com mdpi.com/1422-0067/26/16/8109

Efficacy of Neoadjuvant Cemiplimab Treatment for ... The targeted data revealed a neoadjuvant Cemiplimab mean pathologic response rate of 72%, with a 62% objective response rate. Treatment-related adverse events ( ...

5. targetedonc.com targetedonc.com/view/fda-approves-cemiplimab-for-adjuvant-cscc-treatment

FDA Approves Cemiplimab for Adjuvant Cutaneous ... Cemiplimab significantly improved disease-free survival in high-risk CSCC, reducing recurrence or death risk by 68% compared to placebo. The ...

6. libtayohcp.com libtayohcp.com/cscc/safety

Safety profile - LIBTAYO® (cemiplimab-rwlc) LIBTAYO demonstrated a favorable safety profile in patients with advanced CSCC in clinical studies. 1 Adverse reactions in ≥10% of patients with mCSCC or ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/761097s014lbl.pdf

LIBTAYO® (cemiplimab-rwlc) injection, for intravenous use LIBTAYO is a prescription medicine used to treat: • people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC). LIBTAYO may be used to.

8. ema.europa.eu ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf

Libtayo, INN-cemiplimab - EMA This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked ...

9. regeneron.com regeneron.com/downloads/libtayo_fpi.pdf

LIBTAYO® Full Prescribing Information Adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation. 350 mg every 3 weeks for 12 weeks, followed by. 700 mg ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33736973/

Real world safety outcomes using cemiplimab for ... Conclusions: In our cohort, safety seemed to be worse than in phase II trial with more treatment discontinuations due to cemiplimab toxicity, ...