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SAR444245 + Cemiplimab for Advanced Skin Cancer
Study Summary
This trial is testing a new drug, SAR444245, to see if it is effective in treating tumors when combined with cemiplimab. Secondary objectives include determining the recommended dose of SAR444245 and assessing the safety and other indicators of antitumor activity of the combination.
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.Side effects data
From 2023 Phase 3 trial • 608 Patients • NCT03257267Trial Design
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Who is running the clinical trial?
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- My daily activity is limited due to my health condition.My cancer started on the hairy part of my lip and may extend to the red part.I have a history of lung disease.I haven't taken antibiotics (except creams or ointments) in the last 14 days.I am a male willing to follow specific rules about sperm donation, contraception, and sex.My skin cancer started on the nose, not inside it.I am at least 18 years old or the legal adult age in my country.I have had more than 2 treatments for my advanced cancer.I cannot have imaging tests that require contrast dye.You must have at least one spot that can be measured to see if the treatment is working.I have not received a live-virus vaccine in the last 28 days.I am not pregnant, using birth control, and not donating eggs.I have advanced skin cancer that cannot be treated with surgery or radiation.I have received treatments for advanced cancer before.I haven't had serious heart problems in the last 6 months.I haven't had cancer treatment or major surgery in the last 28 days.My organs are not working well.I have another cancer that has been active or treated in the last 3 years.I have active cancer spread to my brain or its coverings.I need corticosteroids for another health issue.I have received an organ or tissue transplant from another person.Your oxygen level is below 92% when measured at the start of the study.My melanoma cannot be removed by surgery and cannot be treated locally.I have not used immune checkpoint inhibitors for my condition, except as part of initial treatment.I have an autoimmune disease treated in the last 2 years.I am able to understand and sign the consent form.I can provide tumor tissue samples when needed.I had treatment to prevent cancer return within 6 months before my cancer spread.If you have a type of skin cancer called invasive CSCC with some other types mixed in, you might still be able to join the study if the sponsor agrees.
- Group 1: Cohort B: cutaneous squamous cell carcinoma (CSCC)
- Group 2: Cohort A: Melanoma
- 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 maladies is Cemiplimab typically prescribed to treat?
"Cemiplimab is generally used to address ALK gene mutations, but also has been shown to aid in the management of metastatic cutaneous squamous cell carcinoma and other malignant neoplasms."
Could you provide an overview of prior research related to Cemiplimab?
"Cemiplimab was first explored in 2010 by City of Hope. Since then, 6 trials have yielded results and there are currently 56 additional studies actively recruiting participants; many of these experiments take place within New york's boundaries."
How many participants have been accepted for this experimentation?
"Unfortunately, the recruitment period for this medical trial has ended. It was initially posted on July 15th 2021 and its last update occurred October 31st 2022. Luckily, 816 trials are still actively seeking melanoma patients while 56 clinical studies require participants to be treated with Cemiplimab."
In how many sites is this experiment being conducted?
"The current 8 trial sites are located in New york, Beverly Hills and Orlando as well as various other cities. To minimize travel needs, you should seek out the research centre closest to your residence when considering enrolling in this study."
Are there vacancies available for participants in this experiment?
"The information on clinicaltrials.gov suggests that the recruitment period for this trial has ended, as it was first posted in July 2021 and last modified at the end of October 2022. Nonetheless, there are 872 other studies currently enrolling participants."
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