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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Free Survival

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: 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
~1470
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,972 Previous Clinical Trials
597,694 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
Skin Cancer Research Study Groups: Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Skin Cancer 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
~16 spots leftby Oct 2026
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