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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

In this research study, Cemiplimab is being evaluated as a treatment for advanced cutaneous squamous cell carcinoma in participants who have previously received an allogeneic hematopoietic stem cell transplant or kidney transplant. - This research study involves the following drug(s): * Cemiplimab * Everolimus or Sirolimus * Prednisone

Research Team

Glenn J Hanna, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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