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Nivolumab for Melanoma
Study Summary
This trial compares the levels of a drug, immunogenicity, and safety in patients with stage III or IV melanoma who have had surgery.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
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- You have a history of melanoma in your eye.You have a condition where your immune system attacks your own body.There are other requirements that need to be met or avoided as specified in the study guidelines.You had cancer in the past 3 years, but you are eligible if it was a type of cancer that is treatable and has not returned.You cannot have taken strong medications that suppress your immune system, such as corticosteroids, within 14 days of the study. However, if you use inhaled or topical steroids, or need adrenal replacement therapy, you may still be eligible as long as you don't have an active autoimmune disease.
- Group 1: Arm B (Process D)
- Group 2: Arm A (Process C)
- 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
Are there currently openings for participation in this research initiative?
"As indicated on clinicaltrials.gov, this trial is not currently recruiting patients. Initially posted in June 2019 and recently updated in May 2022, the study has ceased enrollment for now; however, there are over 1400 other trials ongoing that require participants."
What conditions can benefit from treatment with Nivolumab?
"Nivolumab is a widely accepted medication for managing malignant neoplasms, as well as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Has Nivolumab been the subject of any other investigations?
"Currently, there are 82 Phase 3 trials and 717 investigations overall that explore the efficacy of nivolumab. Although Basel in Switzerland is hosting most of them, Nivolumab studies can be found in 40282 distinct locations worldwide."
What possible adverse effects could be experienced from utilizing Nivolumab?
"The safety of Nivolumab has been assessed as a 1 by our team at Power due to the limited data that exists from Phase 1 trials, which lacks evidence for both efficacy and safety."
Is this an experimental clinical trial?
"Ono Pharmaceutical Co. Ltd first conducted clinical trials on Nivolumab back in 2012, involving 659 patients. Following successful Phase 1 and 2 drug approval, the number of active studies using this medication has expanded to 717 over 2356 cities and 49 countries globally."
How many clinical sites are actively testing this intervention?
"This trial is currently enrolling from 6 separate sites, located in Hartford, Pittsburgh and Edmonton plus 3 additional cities. It is recommended that you choose the closest site to reduce your travel burden if participating."
What is the maximum capacity of participants for this experiment?
"This trial is no longer actively seeking candidates. It was initially posted on June 24th 2019 and last revised on May 12th 2022. For those looking for other studies, there are currently 753 clinical trials featuring melanoma as the primary focus with an additional 717 dedicated to Nivolumab treatments recruiting participants."
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