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Neoadjuvant Ipilimumab + Nivolumab for Melanoma (NADINA Trial)
NADINA Trial Summary
This trial is testing a new treatment for stage III melanoma that involves two drugs given before surgery, followed by more of one of the drugs or a different drug after surgery.
NADINA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNADINA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NADINA Trial Design
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Who is running the clinical trial?
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- I have undergone radiotherapy before.I am not pregnant or breastfeeding.I don't have health issues that would make the study drug dangerous for me.You have had a serious allergic reaction to similar medications in the past.I have no other cancers, or if I do, they are under control and not expected to affect my life expectancy significantly.I understand and can follow the treatment plan.I have not had immunotherapy targeting CTLA-4, PD-1, or PD-L1.My melanoma is at stage III and can be surgically removed.My cancer has spread to areas between the primary tumor and nearby lymph nodes only.I am fully active or able to carry out light work.I am taking medication that weakens my immune system.I am a man and will use birth control if I have sex with a woman who can get pregnant.I have an active autoimmune disease or a history of one.You will be excluded if you have a positive test for hepatitis B or C.My melanoma is in the eye or mucous membranes.I haven't taken any immunosuppressive drugs in the last 6 months.My melanoma has spread to distant parts of my body.I have not had treatments targeting BRAF or MEK.Your blood test results must meet certain standards.Your LDH level is less than 1.5 times the upper limit of normal.I am 16 years old or older.
- Group 1: A: Neoadjuvant
- Group 2: B: Adjuvant
- 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
Could you please provide a summary of other research that has looked at Neoadjuvant ipilimumab + nivolumab?
"There are currently 800 ongoing clinical trials studying Neoadjuvant ipilimumab + nivolumab, with the majority of these being Phase 3 trials. Out of the 43480 locations running these trials, several are based in Pittsburgh, Pennsylvania."
What was the FDA's decision on Neoadjuvant ipilimumab + nivolumab?
"Given that this is a Phase 3 trial with evidence of efficacy and safety, Neoadjuvant ipilimumab + nivolumab receives a safety score of 3 from our team at Power."
Are new participants being signed up for this research project?
"This clinical trial is presently looking for candidates, according to clinicaltrials.gov. The trial was originally posted on 7/8/2021 and was most recently edited on 6/1/2022."
What are the most common cancers that Neoadjuvant ipilimumab + nivolumab is used to target?
"This combination therapy is most often used to treat patients that have undergone anti-angiogenic therapy previously. Additionally, neoadjuvant ipilimumab + nivolumab can be used to palliate the symptoms of other conditions, such as malignant neoplasms or unresectable melanoma."
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