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Avelumab for Merkel Cell Carcinoma (ADAM Trial)
ADAM Trial Summary
This trial is testing avelumab to see if it can help treat patients with Merkel cell cancer that has spread to the lymph nodes.
ADAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowADAM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 19 Patients • NCT03006848ADAM Trial Design
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Who is running the clinical trial?
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- Your hemoglobin level is at least 9 grams per deciliter.I will begin the study treatment within 120 days after my definitive cancer therapy started.I have an autoimmune disease or had an organ transplant that needed strong immune system drugs.Doctors suspect I still have Merkel cell carcinoma after initial checks.Your platelet count is at least 100 billion per liter.I have a condition like HIV, severe diabetes, or another serious illness that weakens my immune system.I have an active heart condition.You have serious ongoing medical conditions such as severe intestinal or lung problems, or recent mental health issues that could make it unsafe for you to take part in the study.Your AST and ALT levels should be no more than 2.5 times the upper limit of normal.My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.My cancer has spread far from where it started and is not just a local recurrence.I have received treatment for Merkel cell carcinoma before.I haven't had any injections into my tumor in the last 6 months.My Merkel cell carcinoma diagnosis has been confirmed in the lymph nodes.I am 18 years old or older.I am fully active or can carry out light work.I will use effective birth control during and for 30 days after the study if I can conceive.I have finished all initial treatments for Merkel Cell Carcinoma, including surgery or radiation.I haven't had any cancer other than Merkel cell carcinoma in the last 3 years.I do not have severe side effects from previous treatments.My Merkel cell carcinoma has spread to my lymph nodes.I do not have any serious ongoing illnesses that could interfere with the study.You need to have a certain amount of a type of white blood cell called neutrophils in your blood.You are expected to live for more than 3 years.Women who could become pregnant must have a negative pregnancy test before joining the study.I haven't taken any drugs that weaken my immune system in the last 3 months.Your bilirubin level is not higher than 1.5 times the normal range.
- Group 1: Arm I (avelumab)
- Group 2: Arm II (placebo)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is Avelumab a danger to patients who take it?
"Avelumab has received a safety score of 3 by our analysts at Power. This is due to the fact that Avelumab is a Phase 3 trial, which suggests that there is available data that supports both its efficacy and safety."
What is the extent of Avelumab's clinical trial history?
"Avelumab was first studied in 2014 at Helios Klinikum Erfurt. Since then, there have been 18286 completed studies. As of right now, there are 116 active trials, many of which are taking place in Tampa, Florida."
How many human test subjects are taking part in this experiment?
"One hundred study participants that fit the bill are necessary for this trial to happen. EMD Serono, the trial's sponsor, will carry out the experiment at various research facilities; two notable locations are Moffitt Cancer Center in Tampa, Florida and Seattle Cancer Care Alliance in Seattle, Washington."
Is this study being conducted at more than one location within the US?
"Right now, this experiment is being conducted at 10 different sites. If you are considering enrolling, please choose the location nearest to you to limit travel as much as possible. The 10 sites are located in Tampa, Seattle, New york and other cities."
Are there any similar trials to compare this one to?
"There are over a hundred ongoing trials for Avelumab in cities worldwide. The first trial began in 2014 and, after Phase 2 approval, involved 204 people. Since then, there have been 18286 completed studies."
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