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Checkpoint Inhibitor
Neoadjuvant Ipilimumab + Nivolumab for Melanoma (NADINA Trial)
Phase 3
Waitlist Available
Research Sponsored by The Netherlands Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No other malignancies, except adequately treated and with a cancer-related life-expectancy of more than 5 years
No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up analysis will be performed after 132 events, though not later than after 2 years follow-up of all patients.
Awards & highlights
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.
Who is the study for?
This trial is for adults and teens (16+) with stage III melanoma that can be surgically removed. Participants must not have used immunosuppressive drugs in the last 6 months, should have good health status, no history of certain cancers or treatments targeting BRAF/MEK or CTLA-4/PD-1/PD-L1, and no active infections or autoimmune diseases. Women who can bear children and sexually active men must use contraception.Check my eligibility
What is being tested?
The study compares two approaches: one group receives neoadjuvant ipilimumab + nivolumab before surgery followed by adjuvant nivolumab; the other has standard surgery first then adjuvant nivolumab. Some may get additional treatment if they don't respond well initially. The goal is to see which method works better for preventing cancer progression.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting various organs, infusion reactions similar to allergic responses, fatigue, skin issues like rash or itching, digestive problems such as diarrhea or colitis, liver inflammation known as hepatitis, hormone gland problems like thyroid disorders.
NADINA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have no other cancers, or if I do, they are under control and not expected to affect my life expectancy significantly.
Select...
I have not had immunotherapy targeting CTLA-4, PD-1, or PD-L1.
Select...
My melanoma is at stage III and can be surgically removed.
Select...
I am fully active or able to carry out light work.
Select...
I have not had treatments targeting BRAF or MEK.
NADINA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ analysis will be performed after 132 events, though not later than after 2 years follow-up of all patients.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~analysis will be performed after 132 events, though not later than after 2 years follow-up of all patients.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of event-free survival (EFS) in the neoadjuvant and adjuvant group.
Secondary outcome measures
Description of surgical morbidity
Description of type of immune-related adverse events
Neoplasm Metastasis
+7 moreNADINA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: A: NeoadjuvantExperimental Treatment1 Intervention
2 cycles of neoadjuvant ipilimumab (80mg) + nivolumab (240mg) every 3 weeks followed by a total lymph node dissection (TLND) and if applicable, resection of in-transit metastases.
Patients with a pathologic partial or non-response in arm A will also receive adjuvant nivolumab 480 mg every 4 weeks 11 cycles. In case of BRAF V600E/K mutation-positivity, patients will be treated with adjuvant dabrafenib plus trametinib for 46 weeks instead.
Group II: B: AdjuvantActive Control1 Intervention
Standard upfront total lymph node dissection (TLND) and if applicable, resection of in-transit metastases followed by 12 cycles adjuvant nivolumab 480 mg every 4 weeks
Find a Location
Who is running the clinical trial?
The Netherlands Cancer InstituteLead Sponsor
291 Previous Clinical Trials
211,036 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,091 Total Patients Enrolled
Christian Blank, ProfStudy ChairMedical oncologist/researcher
1 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: A: Neoadjuvant
- Group 2: B: Adjuvant
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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