Cemiplimab for Basal Cell Carcinoma

Overseen By Joseph Curry, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Thomas Jefferson University

Must not be taking: Corticosteroids, Immunosuppressants, others

Disqualifiers: Concurrent malignancies, Active infection, others

Stay on Your Current Meds You can continue your current medications while participating

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

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

Compensation: Varies

Number of Visits: 9

Duration: 18 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial tests how well cemiplimab works in treating basal cell carcinoma of the head and neck that has spread to nearby tissue or lymph nodes (locally advanced) before surgery (neoadjuvant). Cemiplimab is a human recombinant monoclonal IgG4 antibody that may allow the body's immune system to work against tumor cells. Giving cemiplimab before surgery may make the tumor smaller and make it easier to remove.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them 28 days before starting the trial.

What data supports the effectiveness of the drug cemiplimab for treating basal cell carcinoma?

Cemiplimab has been shown to be effective for patients with advanced basal cell carcinoma who are resistant to or cannot tolerate hedgehog inhibitor therapy, providing a new treatment option for these patients. It has also been approved for other cancers like cutaneous squamous cell carcinoma, indicating its potential effectiveness in treating various types of cancer. ^{1 2 3 4 5}

Is cemiplimab generally safe for humans?

Cemiplimab has been shown to have acceptable safety in clinical trials for advanced cutaneous squamous cell carcinoma, with low rates of treatment discontinuation and death. Common side effects were noted, but overall, it was considered to have a considerable safety profile. ^{1 2 4 6 7}

How is the drug cemiplimab different from other treatments for basal cell carcinoma?

Cemiplimab is unique because it is an immune checkpoint inhibitor that helps the immune system fight cancer by blocking a protein called PD-1, which can deactivate immune cells. It is specifically used for advanced basal cell carcinoma when other treatments, like hedgehog pathway inhibitors, are no longer effective or tolerated. ^{1 2 4 5 6}

Research Team

Joseph Curry, MD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

Adults with advanced basal cell carcinoma in the head and neck area, who need significant surgery. They should be generally healthy with a life expectancy of at least 6 months, have normal organ function tests, and not be pregnant or breastfeeding. Participants must agree to use effective contraception and cannot have had certain cancer treatments before.

Inclusion Criteria

My cancer affects specific parts of my body.

My skin cancer on my head or neck needs surgery.

I am fully active or can carry out light work.

Exclusion Criteria

I have had pneumonitis in the last 5 years.

I do not have active infections like TB, hepatitis B, C, or HIV.

I have had radiation therapy for my cancer within the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive cemiplimab intravenously every 21 days for up to 6 cycles

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person)

Treatment Details

Interventions

• Cemiplimab

Trial Overview The trial is testing Cemiplimab's effectiveness when given before surgery for shrinking tumors in patients with locally advanced basal cell carcinoma of the head and neck. It's a phase II study where all participants receive Cemiplimab along with pre-surgery evaluations like CT scans.

Participant Groups

Group I: Treatment (cemiplimab) Experimental Treatment 6 Interventions

Patients receive cemiplimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may transition to SOC HHI therapy. Patients undergo CT or MRI scans and collection of blood samples throughout the trial. Patients also undergo biopsies during screening and on study.

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?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Findings from Research

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, an immune checkpoint inhibitor, showed a 22% objective response rate in patients with metastatic basal cell carcinoma (mBCC) who had previously progressed on hedgehog pathway inhibitors, indicating its potential effectiveness as a second-line treatment.

The treatment was well-tolerated with no treatment-related deaths, and the median progression-free survival was 10 months, suggesting that cemiplimab can provide meaningful antitumor activity and durable responses in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Final analysis of phase II results with cemiplimab in metastatic basal cell carcinoma after hedgehog pathway inhibitors. Lewis, KD., Peris, K., Sekulic, A., et al.[2023]

In two elderly patients with advanced synchronous basal cell carcinoma and cutaneous squamous cell carcinoma, a combined therapy of the PD-1 inhibitor cemiplimab and the Sonic Hedgehog inhibitor sonidegib was administered at full doses, resulting in significant clinical benefits and long-term responses without major side effects.

This case highlights the potential for effective systemic treatment options for advanced BCC/cSCC, suggesting that the combination of targeted therapies and immunotherapy could be a promising avenue for future research, especially as the population ages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of cemiplimab plus sonidegib for synchronous cutaneous squamous cell carcinoma and basal cell carcinoma of the head and neck: Two case reports. Colombo, E., Gurizzan, C., Ottini, A., et al.[2023]

Cemiplimab has been approved as a second-line treatment for patients with advanced basal cell carcinoma (BCC) who are resistant to or intolerant of hedgehog inhibitor therapy, addressing a significant gap in treatment options.

While small-molecule inhibitors targeting the hedgehog pathway have been effective for many BCC patients, they can lead to resistance and have challenging side effects, making cemiplimab a crucial alternative for those with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief overview: cemiplimab for the treatment of advanced basal cell carcinoma: PD-1 strikes again. Davis, CM., Lewis, KD.[2022]

Cemiplimab demonstrated clinically meaningful antitumor activity in patients with locally advanced basal cell carcinoma who had progressed on hedgehog inhibitor therapy, with an objective response rate of 31% in a study of 84 patients.

The treatment had an acceptable safety profile, with 48% of patients experiencing grade 3-4 adverse events, but no treatment-related deaths were reported, indicating it is a viable option for patients intolerant to previous therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Stratigos, AJ., Sekulic, A., Peris, K., et al.[2021]

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 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]

References

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

Cemiplimab: First Global Approval. [2023]

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

Final analysis of phase II results with cemiplimab in metastatic basal cell carcinoma after hedgehog pathway inhibitors. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The association of cemiplimab plus sonidegib for synchronous cutaneous squamous cell carcinoma and basal cell carcinoma of the head and neck: Two case reports. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Brief overview: cemiplimab for the treatment of advanced basal cell carcinoma: PD-1 strikes again. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Cemiplimab in advanced cutaneous squamous cell carcinoma. [2022]