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PD-1 Inhibitor

Radiotherapy + Cemiplimab for Skin Cancer

Phase 2

Recruiting

Led By Christopher Barker, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Biopsy proven cutaneous squamous cell carcinoma which is locally advanced

≥18 years old

Must not have

Current or previous hematopoietic malignancy (leukemia, lymphoma)

Iatrogenic immunosuppression (>prednisone 10 mg/day or equivalent within 14 days of initiation of treatment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Summary

This trial looks at whether radiation and a new drug could treat advanced skin cancer that can't be removed.

Who is the study for?

This trial is for adults over 18 with a specific skin cancer (CSCC) that can't be removed by surgery. They should have a life expectancy of more than 18 months, be fit enough for radiotherapy and immunotherapy, and not have other serious health issues or ongoing cancer treatments. Pregnant or breastfeeding women are excluded.Check my eligibility

What is being tested?

The study tests if combining radiation therapy with an immunotherapy drug called Cemiplimab works well against advanced CSCC that cannot be surgically removed. Participants will receive both treatments to see how effective they are together.See study design

What are the potential side effects?

Possible side effects include typical reactions to radiation like skin irritation and fatigue, as well as immune-related effects from Cemiplimab such as inflammation in various organs, flu-like symptoms, and potential impact on hormone levels.

Eligibility Criteria

Inclusion Criteria

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

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My skin cancer is advanced but hasn't spread beyond the skin.

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I am 18 years old or older.

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My cancer is at an advanced local stage, classified as T3-T4 or has spread to nearby lymph nodes.

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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

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

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I have or had blood cancer (like leukemia or lymphoma).

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I have not taken more than 10 mg of prednisone or similar drugs daily in the last 14 days.

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I have had a transplant of an organ or bone marrow from another person.

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I have had radiation therapy for skin cancer.

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My HIV or hepatitis is not under control.

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I do not have any other cancers with a high risk of spreading or causing death within 2 years.

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My cancer started in the mucosal areas of the lip, nose, or anogenital region.

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I have previously used aPD1 immunotherapy or PI3Kδ inhibitors.

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I need medication to manage my autoimmune disease.

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Free Survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCCExperimental Treatment2 Interventions

Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

Radiotherapy

2017

Completed Phase 3

~2610

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,944 Previous Clinical Trials

589,717 Total Patients Enrolled

Christopher Barker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

6 Previous Clinical Trials

318 Total Patients Enrolled

Media Library

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05574101 — Phase 2

Squamous Cell Carcinoma Research Study Groups: Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC

Squamous Cell Carcinoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT05574101 — Phase 2

Cemiplimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05574101 — Phase 2

~18 spots leftby Oct 2026

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