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Checkpoint Inhibitor

Cemiplimab for Skin Cancer

Phase 2

Recruiting

Led By Gino K In, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

Patients must have disease that is considered either: (1) high-risk localized CSCC, (2) locally recurrent CSCC, or (3) regionally advanced CSCC

Histologically confirmed, cutaneous squamous cell carcinoma

Must not have

Immunosuppressive systemic corticosteroids equivalent to prednisone 10 mg or greater in the 14 days prior to the first dose of cemiplimab

Any major surgery within 14 days prior to the first dose of cemiplimab. Patients must have recovered from any major complications before registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 9 weeks

Awards & highlights

Summary

This trial looks at using immunotherapy with cemiplimab to treat patients with skin cancer before surgery.

Who is the study for?

This trial is for adults with high-risk, resectable skin cancer that's localized, locally recurrent, or regionally advanced. They must have measurable disease and not have had prior PD-1/PD-L1 inhibitors or immune therapies within 4 weeks. Major organ functions need to be stable, no uncontrolled illnesses are allowed, and they can't be pregnant or breastfeeding. Participants should agree to use contraception during the study.

What is being tested?

The trial tests if cemiplimab given before surgery can help treat patients with certain types of skin cancer. Cemiplimab is a monoclonal antibody designed to boost the body's immune response against cancer cells by blocking the PD-1 pathway which tumors use to evade attack.

What are the potential side effects?

Cemiplimab may cause fatigue, skin reactions at injection sites, diarrhea, muscle pain and weakness. It might also lead to more serious issues like inflammation in organs such as lungs (pneumonitis), liver (hepatitis), intestines (colitis) or hormone glands.

Eligibility Criteria

Inclusion Criteria

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

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My skin cancer is either high-risk, has come back, or has spread locally.

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My skin cancer is confirmed as squamous cell carcinoma.

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My CSCC has at least two high-risk features based on its size, location, growth rate, or specific cell types.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I haven't taken high doses of steroids like prednisone (10 mg or more) in the last 2 weeks.

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I have not had major surgery in the last 2 weeks or have recovered from any complications.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I haven't taken any immune therapy drugs in the last 4 weeks.

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I am not on any other cancer treatments while on this trial.

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I have previously been treated with drugs targeting PD-1 or PD-L1.

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I have had allergic reactions to specific cancer treatments before.

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I have had a solid organ or bone marrow transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 9 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Confirmed pathologic partial response

Secondary study objectives

Incidence of toxicities

Objective response rate

Pathologic complete response rate

+1 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Hyperthyroidism

13%

Constipation

13%

Vomiting

13%

Nausea

13%

Diarrhoea

13%

Subcutaneous abscess

13%

Infusion related reaction

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy to Cemiplimab*

Cemiplimab

Chemotherapy*

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cemiplimab, surgical resection)Experimental Treatment2 Interventions

Patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Resection

2023

Completed Phase 2

~420

Cemiplimab

FDA approved

0 / 12Eligibility criteria met