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Nivolumab +/− Ipilimumab for Melanoma
Study Summary
This trial will compare the effectiveness of two immunotherapy drugs, Nivolumab and Ipilimumab, given alone or in combination, to Ipilimumab given alone in patients with advanced melanoma.
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 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
Media Library
- I have active cancer spread to my brain or its coverings.I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.My melanoma is at an advanced stage and cannot be surgically removed.I have been treated with specific immune therapy drugs before.I have not received any treatment for my condition.My cancer can be measured by scans.I can provide a tissue sample from my cancer that cannot be surgically removed or has spread.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with eye melanoma.You have a known autoimmune disease that is currently active or suspected.
- Group 1: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab
- Group 2: Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab
- Group 3: Arm C: Ipilimumab+Placebo for Nivolumab
- 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 research facilities are overseeing this trial?
"There are a total of 100 patients enrolled in this study, with some coming from Local Institution - 0098 in Washington, Local Institution - 0080 in Lutherville, and the California Pacific Medical Center Research Institute in San Francisco. There are 100 other locations participating as well."
Does Nivolumab have any serious side effects?
"Nivolumab's safety was ranked a 3 by our analysts at Power. This is due to the fact that this is a Phase 3 trial, which means that, in addition to some data supporting efficacy, there are multiple rounds of data supporting safety."
How many people are expected to sign up for this research project?
"Unfortunately, this specific clinical trial is not recruiting patients right now. Although, it was updated as recently as October 7th, 2022. There are 782 other trials for unresectable or metastatic melanoma and 801 for Nivolumab that are still looking for patients to enroll."
What are the standard treatments for which Nivolumab is used?
"Nivolumab has been found to be an effective treatment against various conditions, such as malignant neoplasms and unresectable melanoma. It is often used as a form of anti-angiogenic therapy."
Are there other similar treatments to Nivolumab that have been studied before?
"Out of the 801 ongoing Nivolumab trials, 87 of them are in Phase 3 testing. Although the city of Pittsburgh, Pennsylvania has a significant amount of trials underway, 43516 locations worldwide are running Nivolumab studies."
Are there any patients currently being sought for this trial?
"Unfortunately, this specific trial is not currently recruiting patients. Although, there are 1583 other active trials that are seeking participants. This trial was originally posted on June 11th, 2013 and was last updated on October 7th, 2022."
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