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Cemiplimab for Merkel Cell Carcinoma
Study Summary
This trial is testing if a new cancer drug is safe and effective in treating Merkel Cell Carcinoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Neoadjuvant Cemiplimab Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What primary applications does Cemiplimab-Rwlc possess?
"Cemiplimab-Rwlc is traditionally used to address alk gene mutations, but can also be deployed to treat metastatic cutaneous squamous cell carcinoma, malignant neoplasms, and advance directives."
Are there any openings for volunteers to join this experiment?
"The trial's listing on clinicaltrials.gov states that it is actively recruiting patients, having first been published on October 22nd 2021 and most recently updated November 15th 2022."
What is the enrolment count for this clinical research project?
"Affirmative. The details posted to clinicaltrials.gov demonstrate that this medical research, which began recruiting participants on October 22nd 2021, is actively seeking volunteers now. 30 individuals need to be recruited for the experiment from 1 selected area."
What have been the outcomes of past research initiatives involving Cemiplimab-Rwlc?
"Currently, 56 trials exploring the effects of Cemiplimab-Rwlc are active with 4 in Phase 3. While most of these clinical investigations take place in Barcelona and California, a total of 1741 sites around the world have been conducting such studies."
What potential risks could be associated with using Cemiplimab-Rwlc for therapeutic purposes?
"The safety of Cemiplimab-Rwlc was ranked a 1 on the scale due to its Phase One status, meaning that there is only limited data supporting both efficacy and security."
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