Cemiplimab for Basal Cell Carcinoma

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively the drug cemiplimab can shrink tumors in individuals with basal cell carcinoma, a type of skin cancer on the head or neck, before surgery. Cemiplimab is designed to enhance the immune system's ability to fight cancer cells, potentially reducing tumor size and making them easier to remove. Suitable candidates have skin cancer that has spread to nearby tissues or lymph nodes and require significant surgery, such as the removal of parts of the nose, ear, or eyelid. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

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

Research has shown that cemiplimab is generally safe for treating certain types of skin cancer. Studies have found that most patients tolerate cemiplimab well. Common side effects are usually mild and include tiredness, rash, or diarrhea, while serious side effects are less common.

Cemiplimab is also approved for treating other skin cancers, indicating its safety for use in people. This approval means it has been tested and found safe for other conditions, although each condition can differ.

Overall, cemiplimab appears to be a promising treatment with a manageable safety profile in clinical settings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Cemiplimab is unique because it targets the PD-1 pathway, which is a different approach compared to the standard treatments for basal cell carcinoma, like Hedgehog pathway inhibitors (HHIs). This immunotherapy helps the body's immune system recognize and attack cancer cells, offering a potential option for patients who don't respond well to existing therapies. Researchers are excited because cemiplimab provides a new mechanism of action that could be more effective for certain patients with advanced basal cell carcinoma.

What evidence suggests that cemiplimab might be an effective treatment for basal cell carcinoma?

Research has shown that cemiplimab, which participants in this trial will receive, works well for treating basal cell carcinoma (BCC). In studies, patients with advanced BCC saw improvements in about three months. Cemiplimab is already approved for treating advanced BCC, making it a recognized treatment. It also significantly lowers the risk of the cancer returning or causing death in similar cases. Overall, cemiplimab is considered a promising option for reducing tumor size before surgery. ^{2 3 4 6 7}

Who Is on the Research Team?

Joseph Curry, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

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.

Must have a life expectancy of at least 6 months

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 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 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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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-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]

Citations

1. 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).

2. 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/ ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)04329-6/fulltext

Final analysis of phase II results with cemiplimab in ... The median time to response with cemiplimab was ∼2 months in advanced CSCC, versus ∼3 months in advanced BCC per central review. The differences ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11083599/

Efficacy and Safety of Cemiplimab for the Management of Non ... 4. Basal Cell Carcinoma. Cemiplimab has received approval as a standalone therapy for managing adult patients with laBCC or mBCC who have either ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925003727

versus second-line cemiplimab for advanced basal cell ... We demonstrate a comparable outcome for cemiplimab as second-line treatment of BCC in our real-world patient cohort as reported in previous registration ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9421083/

Cemiplimab and Cutaneous Squamous Cell Carcinoma Advanced cutaneous squamous cell carcinoma: A retrospective analysis of patient profiles ... cell carcinoma (CSCC): Longer follow-up efficacy and safety data.