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Cytokine
IL2 + Ipilimumab and Nivolumab for Melanoma
Phase 2
Recruiting
Led By Shahla Bari, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pulmonary function tests (PFTs) required for patients over 50 years old or with significant pulmonary or smoking history
Histologically or cytologically confirmed metastatic melanoma including AJCC stage IV or advanced/inoperable stage III
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test whether adding Interleukin-2 to standard ipilimumab and nivolumab treatment will improve outcomes for people with advanced melanoma.
Who is the study for?
This trial is for adults with advanced melanoma who have had prior anti-PD1 immunotherapy but their disease got worse. They must be in good health otherwise, not have serious heart issues or brain metastasis, and agree to use contraception. It's not for those with autoimmune diseases on steroids, other cancers (unless free of disease for over 2 years), or recent treatments that they haven't recovered from.Check my eligibility
What is being tested?
The study tests if giving Interleukin-2 at the same time as ipilimumab followed by nivolumab can better fight advanced melanoma. Participants will receive these drugs sequentially to see if this combination improves cancer control compared to previous treatments they've received.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in different organs, skin rash, hormone gland problems (like thyroid dysfunction), fatigue, and flu-like symptoms due to interleukin-2; gastrointestinal issues and potential liver toxicity could also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 50 or have a history of lung issues or smoking, and need lung function tests.
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My melanoma is confirmed to be at an advanced stage and cannot be removed by surgery.
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I have no heart conditions like heart failure or recent heart attacks.
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I am fully active or can carry out light work.
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My cancer progressed after treatment with nivolumab or pembrolizumab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate
Secondary outcome measures
Overall Survival
Progression Free Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment3 Interventions
HD IL2 (600,000 units/kg/dose IV) will be given during week 1 of the 2 initial cycles or each course. Ipilimumab will be given concurrently at the low dose of 1 mg/kg during week one of the 2 initial cycles of each course for up to 2 doses, total. Nivolumab will be given on during week one of the 3rd cycle of each course. No systemic treatment will be administered during the 4th cycle. Patients without evidence of disease progression (RECIST v.1.1) or limiting toxicities will be offered additional courses of treatment for up to a maximum of 3 courses, total.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin-2
1994
Completed Phase 3
~700
Ipilimumab
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
546 Previous Clinical Trials
135,563 Total Patients Enrolled
43 Trials studying Melanoma
3,189 Patients Enrolled for Melanoma
Clinigen, Inc.Industry Sponsor
9 Previous Clinical Trials
328 Total Patients Enrolled
3 Trials studying Melanoma
82 Patients Enrolled for Melanoma
Shahla Bari, MDPrincipal InvestigatorMoffitt Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart or brain blood vessel problems.I haven't had a stroke or mini-stroke in the last 6 months.I am over 50 or have a history of lung issues or smoking, and need lung function tests.I had major surgery over 4 weeks ago and have fully recovered.My melanoma is confirmed to be at an advanced stage and cannot be removed by surgery.I have active cancer spread to my brain.My heart test showed low or no risk of heart issues recently.I agree to use birth control during and for 6 months after the study.I haven't had melanoma treatment or radiation in the last 3 weeks and have recovered from any past treatments.My recent scans show no active brain tumors.I have been cancer-free from any other cancer for over 2 years.My organ and bone marrow functions are normal.I have no heart conditions like heart failure or recent heart attacks.You need to have a negative pregnancy test within two weeks before joining the study.I am fully active or can carry out light work.I have a history of adrenal insufficiency.I am currently on medication for an autoimmune disorder or to suppress my immune system.You have a disease that can be measured using a specific method called RECIST version 1.1.My cancer progressed after treatment with nivolumab or pembrolizumab.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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