Cemiplimab for Squamous Cell Carcinoma

(CONTRAC Trial)

Overseen By Glenn J Hanna, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Dana-Farber Cancer Institute

Must be taking: Cemiplimab, Everolimus, Sirolimus, Prednisone

Must not be taking: CYP3A4 inhibitors, Immunotherapy

Disqualifiers: Autoimmune conditions, HIV, Hepatitis, 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: 21

Duration: Up to 100 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Cemiplimab for individuals with advanced skin cancer (cutaneous squamous cell carcinoma) who have undergone a stem cell or kidney transplant. The goal is to evaluate Cemiplimab's effectiveness alone or in combination with other drugs like Everolimus, Sirolimus, and Prednisone for treating this cancer type. Suitable candidates include those with a history of transplants and advanced skin cancer unresponsive to other treatments. As a Phase 1 and Phase 2 trial, this research seeks to understand the treatment's effects and measure its effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants cannot take strong inhibitors or inducers of CYP3A4. If you are on such medications, you may need to stop or adjust them. It's best to discuss your current medications with the trial team.

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

Research shows that cemiplimab is generally well-tolerated by patients. One study found it effective and manageable for people with advanced skin cancer, even among older patients with other health issues. About 52% of these patients responded positively to the treatment.

For patients who have had a kidney transplant, cemiplimab is sometimes combined with other drugs like everolimus or sirolimus and prednisone. These combinations remain under study, but cemiplimab is already approved for certain cancer treatments, suggesting it is relatively safe. While more research is needed, current findings indicate that cemiplimab is a promising option with a manageable safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for squamous cell carcinoma, which often include surgery, radiation, and chemotherapy, Cemiplimab works differently by harnessing the immune system. This drug is a monoclonal antibody that targets the PD-1 pathway, a mechanism that cancer cells use to hide from the immune system. By blocking this pathway, Cemiplimab helps the immune system recognize and attack cancer cells more effectively. Researchers are excited about this approach because it offers a more targeted treatment that could potentially lead to fewer side effects and improved outcomes compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for advanced cutaneous squamous cell carcinoma?

Research has shown that cemiplimab effectively treats cutaneous squamous cell carcinoma (CSCC). One study found that cemiplimab helped patients with CSCC live longer without disease recurrence. In this trial, participants in Cohort 1 will receive cemiplimab alone. Those in Cohort 2, who have had a kidney transplant, will receive cemiplimab along with other medications like everolimus or sirolimus and prednisone. This combination did not cause kidney rejection and still effectively fought the cancer. Cemiplimab is approved for treating advanced CSCC, indicating expert confidence in its ability to manage this cancer. Overall, the evidence supports cemiplimab as a promising treatment for patients with advanced CSCC. ^{1 2 6 7 8}

Who Is on the Research Team?

Glenn J Hanna, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Adults with advanced skin cancer who've had a stem cell or kidney transplant can join. They need to be in decent health, have good organ function, and no severe immune conditions. Women must test negative for pregnancy and use contraception; men also need to use effective birth control.

Inclusion Criteria

I can care for myself but may not be able to do active work.

Willingness to provide blood and tissue from diagnostic biopsies

I have advanced skin cancer with a tumor larger than 1 cm.

Exclusion Criteria

I do not have any uncontrolled illnesses.

Participants receiving any other investigational agents

I have previously been treated with specific immunotherapies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cemiplimab every 21 days. Kidney transplant recipients also receive Everolimus or Sirolimus and Prednisone.

Up to 100 days

Every 21 days for Cemiplimab administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival and overall survival.

Up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Everolimus
• Prednisone
• Sirolimus

Trial Overview The trial is testing Cemiplimab's effectiveness on advanced cutaneous squamous cell carcinoma in patients post-transplant. It includes drugs like Everolimus or Sirolimus and Prednisone as part of the treatment regimen.

How Is the Trial Designed?

Group I: Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone Experimental Treatment 4 Interventions

Participants who received a kidney transplant will receive * Cemiplimab via IV, flat predetermined dosage every 21 days * Everolimus or Sirolimus-least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab * Prednisone 40 mg orally the day prior to the start of cemiplimab dosing (Cycle 1, Day 1) and then daily at tapering doses while receiving Cemiplimab

Group II: Cohort 1 Cemiplimab Experimental Treatment 1 Intervention

Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 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?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

1. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-plus-chemotherapy-results-five-years

Libtayo® (cemiplimab) Plus Chemotherapy Results at Five ... “Long-term results across tumor histologies were also reported, including a notable 22.3-month median overall survival for squamous NSCLC ...

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

Real-World Treatment Patterns and Outcomes of Cemiplimab ... Pooled longer term data from the Phase 2 clinical trial for cemiplimab (NCT02760498; median follow-up, 15.7 months) showed an objective response ...

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. 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-free ...

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

Up to 5 years of Long-term follow-up data Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Lancet Oncol. 2020;21(2):294-305. 8 ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772611823000071

Real-world data on tolerability and clinical response of ... Cemiplimab demonstrated to be well-tolerated, even in elderly patients with severe comorbidities, achieving an objective response in 52% of patients.

7. 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).

8. nejm.org nejm.org/doi/pdf/10.1056/NEJMoa2502449

Adjuvant Cemiplimab or Placebo in High The current trial was successful in defining a popu- lation of patients at high risk for recurrence of cutaneous squamous-cell carcinoma as ...