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PD-1 Inhibitor

Cemiplimab for Skin Cancer

Phase 1

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have measurable disease in the index lesion, as defined by modified WHO criteria. Measurable disease is defined as at least one lesion that is at least 1 cm in both of the longest perpendicular diameters.

Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Must not have

Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.

Has received a COVID-19 vaccination (initial series and booster) within 1 week of planned start of study medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first dose to 90 days after the last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug, cemiplimab, to see if it is safe and effective for treating patients with skin cancer. The study will also look at the side effects of the drug and how well it works.

Who is the study for?

Adults with Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma that can be measured and has recurred. Participants should have good performance status (ECOG ≤1) and no other serious illnesses or recent vaccinations. Those with a history of certain cancers, immune diseases, organ transplants, or previous PD-1/PD-L1 pathway treatments are excluded.

What is being tested?

The trial is testing the safety and effects of an experimental drug called cemiplimab on skin cancer tumors. It involves weekly doses for 12 weeks to see how the body reacts, what side effects occur, the impact on tumors, and how much drug stays in the blood over time.

What are the potential side effects?

Potential side effects from cemiplimab may include reactions related to immune system activation such as inflammation in various organs, fatigue, possible infusion-related reactions similar to allergic responses, and changes in blood tests indicating liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured and is at least 1 cm in size.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with drugs that target the PD-1/PD-L1 pathway.

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I have been fully vaccinated for COVID-19, including the booster, within the last week.

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I have had a solid organ transplant.

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I have previously been treated with drugs that affect the immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days after last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5

Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5

Secondary study objectives

Objective response rate (ORR) of index lesion

Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Subcutaneous abscess

13%

Diarrhoea

13%

Hyperthyroidism

13%

Nausea

13%

Constipation

13%

Infusion related reaction

13%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy to Cemiplimab*

Cemiplimab

Chemotherapy*

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CemiplimabExperimental Treatment1 Intervention

Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated. Cohorts D, H and I may open after completion of Cohort B. Note: Cohort E through G will not be opened for participation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1470

0 / 6Eligibility criteria met