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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study 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 blood tests show my bone marrow and metabolism are functioning well.
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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.
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My condition cannot be treated with surgery according to a team of doctors.
Select...
My doctors agree I can have radiotherapy and Cemiplimab immunotherapy with a goal to cure.
Select...
My tumor is mainly squamous cell carcinoma.

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

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

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,588 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC at risk for any negative long-term effects?

"While Phase 2 trials have not yet yielded data regarding a treatment's efficacy, there is some evidence that suggests it could be safe for participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC."

Answered by AI

How many individuals are being asked to participate in this research project?

"The clinical trial is currently ongoing, as indicated by the latest update on October 12th, 2020. This study was originally posted on October 6th, 2020 and is looking for a total of 34 patients from 13 different locations."

Answered by AI

Are patients able to sign up for this experiment right now?

"Yes, this study is still recruiting patients. The listing on clinicaltrials.gov shows that the trial was first posted on October 6th, 2020 and was last updated on October 12th, 2020."

Answered by AI
~21 spots leftby Oct 2026