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Cemiplimab for Merkel Cell Carcinoma
Phase 1
Recruiting
Led By Ahmad Tarhini, MD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance Status of 0, 1, or 2
Histologically proven diagnosis of Merkel cell carcinoma (MCC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing if a new cancer drug is safe and effective in treating Merkel Cell Carcinoma.
Who is the study for?
This trial is for adults with newly diagnosed or recurrent Stage I-II Merkel Cell Carcinoma, or advanced Cutaneous Squamous Cell Carcinoma. Candidates must be fit for surgery, have an ECOG status of 0-2, and agree to use effective contraception if applicable. Excluded are those with other recent cancers, certain immune conditions, severe allergies to cemiplimab components, and uncontrolled infections.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Cemiplimab-Rwlc when given before tumor removal surgery in treating Merkel Cell Carcinoma and Cutaneous Squamous Cell Carcinoma. Participants will receive Cemiplimab prior to their scheduled surgeries.See study design
What are the potential side effects?
Cemiplimab may cause side effects such as fatigue, skin reactions at the injection site, muscle aches, possible immune-related issues like inflammation in organs (including lungs), allergic reactions similar to past antibody treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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My condition is confirmed as Merkel cell carcinoma.
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My Merkel cell carcinoma is in stage I or II.
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I have stage II to IV CSCC in sensitive areas or other parts and surgery is planned.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Adverse Events Related to Study Treatment
Secondary outcome measures
Overall Survival
Relapse Free Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant Cemiplimab TreatmentExperimental Treatment1 Intervention
Participants will receive cemiplimab 350 mg IV at least 3 weeks prior to surgical resection. After surgery they will continue to receive 350 mg cemiplimab every 3 weeks for up to 8 additional doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab-Rwlc
2019
Completed Phase 2
~40
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Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
628 Previous Clinical Trials
382,212 Total Patients Enrolled
Sanofi-SynthelaboIndustry Sponsor
49 Previous Clinical Trials
34,636 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
546 Previous Clinical Trials
135,562 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blood cancer, such as chronic lymphocytic leukemia.I stopped taking cancer immune therapy because of its side effects.I can take care of myself and am up and about more than half of my waking hours.I have an autoimmune disease treated with drugs that affect my immune system in the last 5 years.I have had a stem cell transplant from a donor or myself.I am 18 years old or older.I have not received a live vaccine in the last 28 days.If you have HIV, you can still participate if your HIV is under control and can't be detected in your blood.I have had a solid organ transplant.I am eligible for surgery to remove a large area of my cancer and possibly check nearby lymph nodes.I haven't been hospitalized for an infection or needed IV antibiotics in the last 2 weeks.I have active tuberculosis.I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.I have received immunotherapy for Merkel cell carcinoma.I have no other cancers except for localized CSCC or had any cancer other than Merkel cell carcinoma in the last 3 years.I have had lung conditions treated with high-dose steroids.I am allergic to ingredients in the cemiplimab medication.My condition is confirmed as Merkel cell carcinoma.My Merkel cell carcinoma is in stage I or II.I am willing and able to follow all study rules and attend all appointments.I am a man who can father children and will use contraception.I do not have an uncontrolled HIV, HBV, or HCV infection.I have stage II to IV CSCC in sensitive areas or other parts and surgery is planned.I have not had a heart attack in the last 6 months.I haven't taken high doses of steroids in the last 4 weeks.I have had lung inflammation due to immune response in the last 5 years.You have had serious allergic reactions to antibody treatments in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant Cemiplimab Treatment
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.
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