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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 belowSelect...
My skin cancer is advanced but hasn't spread beyond the skin.
Select...
I am 18 years old or older.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
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
1,935 Previous Clinical Trials
588,821 Total Patients Enrolled
Christopher Barker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
318 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My skin cancer is advanced but hasn't spread beyond the skin.I have or had blood cancer (like leukemia or lymphoma).I have not taken more than 10 mg of prednisone or similar drugs daily in the last 14 days.I have had a transplant of an organ or bone marrow from another person.I am 18 years old or older.My blood tests show my bone marrow and metabolism are functioning well.I have had radiation therapy for skin cancer.My cancer is at an advanced local stage, classified as T3-T4 or has spread to nearby lymph nodes.I can take care of myself and am up and about more than 50% of my waking hours.My condition cannot be treated with surgery according to a team of doctors.My HIV or hepatitis is not under control.You are currently receiving treatment for another type of cancer.I do not have any other cancers with a high risk of spreading or causing death within 2 years.I have no health issues in the last year that could affect study results.You are expected to live for more than 18 months.My doctors agree I can have radiotherapy and Cemiplimab immunotherapy with a goal to cure.My cancer started in the mucosal areas of the lip, nose, or anogenital region.My tumor is mainly squamous cell carcinoma.I have previously used aPD1 immunotherapy or PI3Kδ inhibitors.I need medication to manage my autoimmune disease.I am not using birth control while on cemiplimab and won't for 4 months after.My cancer has spread to distant parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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