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Neoadjuvant Daromun + Surgery for Melanoma (NeoDREAM Trial)
NeoDREAM Trial Summary
This trial hopes to find that Daromun, a neoadjuvant treatment, followed by surgery and adjuvant therapy, will improve the recurrence-free survival of Stage IIIB/C melanoma patients.
NeoDREAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNeoDREAM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NeoDREAM Trial Design
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Who is running the clinical trial?
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- My cancer has spread to distant parts of my body.You are expected to live for more than 24 months.I have tested negative for HIV, Hepatitis B, and Hepatitis C.Your total bilirubin level in the blood needs to be below a certain number.Your LDH blood test results are within a certain range.Your white blood cell count is too high.I haven't had any cancer treatment except minor surgery in the last 4 weeks.I am 18 years old or older.I have had cancer before, but it was a different type or treated over 5 years ago.I have severe blockages in my arteries.I have severe damage to my retina due to diabetes.I have had a heart attack or severe chest pain in the last year.You have an ongoing autoimmune disease.I have had an organ or stem cell transplant.I have melanoma that can be measured and treated by injection.My cancer is either in the eye (uveal melanoma) or in the mucous membranes (mucosal melanoma).Your hemoglobin level is higher than 9.0 grams per deciliter.Your kidney function, as measured by creatinine levels in your blood, is within a certain range.I do not have any active infections or severe diseases that would risk my participation.My blood pressure is not controlled by medication.I haven't had any antibody treatments for the past 6 weeks.All side effects from my previous treatments, except for hair loss, are mild or gone.I agree to use two forms of birth control with my partner until three months after my last treatment.I am on long-term corticosteroids or immunosuppressants.I will not receive growth factors or immune-boosting drugs within a week before joining.I have stage IIIB or IIIC melanoma that can be completely removed by surgery.I can carry out all my usual activities without help.I am not pregnant, will use effective birth control, and agree to pregnancy tests.Your ALT and AST liver enzyme levels are not more than 2.5 times the upper limit of normal.I have not had major surgery or serious injury in the last 4 weeks.I am currently breastfeeding.Your platelet count is higher than 100 billion per liter.My heart condition is not severe (not worse than NYHA Grade II).My heart's pumping ability is reduced, or I have significant heart test abnormalities.My heart rhythm problem is not well controlled.You have had an allergic reaction to certain proteins or antibodies used in the study drug.I am willing and able to follow the study's schedule and procedures.
- Group 1: Daromun plus Surgery and Adjuvant therapy (Arm 1)
- Group 2: Surgery and adjuvant therapy (Arm 2)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many individuals are enrolled in this clinical trial?
"That is correct. The clinicaltrials.gov website provides updated information about this trial, which began enrolling patients on 9/20/2018. As of 10/21/2022, there are 186 enrollees from 12 different sites."
Are new participants currently being accepted for this experiment?
"That is correct. The listing on clinicaltrials.gov says that the study is currently looking for volunteers. The trial was first advertised on September 20th, 2018 and has since been updated October 21st, 2022. A total of 186 people are needed to enroll at 12 different sites."
What are the government's thoughts on using Adjuvant therapy?
"Adjuvant therapy has been shown to be effective in multiple trials, so it receives a score of 3."
Could you please summarize how many locations are conducting this experiment?
"There are presently 12 sites where this trial is being conducted. Some of the locations include Columbus, Hershey and La Jolla. If you choose to enroll in this study, please try and select the nearest site to reduce travel requirements."
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