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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
No history of cerebrovascular accident or transient ischemic attacks within the past 6 months from registration
Pulmonary function tests (PFTs) required for patients over 50 years old or with significant pulmonary or smoking history
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 below
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I haven't had a stroke or mini-stroke in the last 6 months.
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I am over 50 or have a history of lung issues or smoking, and need lung function tests.
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I had major surgery over 4 weeks ago and have fully recovered.
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My melanoma is confirmed to be at an advanced stage and cannot be removed by surgery.
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My heart test showed low or no risk of heart issues recently.
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I agree to use birth control during and for 6 months after the study.
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My recent scans show no active brain tumors.
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My organ and bone marrow functions are normal.
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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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
Ipilimumab
2014
Completed Phase 3
~2670
Interleukin-2
1994
Completed Phase 3
~700
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
540 Previous Clinical Trials
135,406 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

Media Library

Interleukin-2 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT04562129 — Phase 2
Melanoma Research Study Groups: Treatment
Melanoma Clinical Trial 2023: Interleukin-2 Highlights & Side Effects. Trial Name: NCT04562129 — Phase 2
Interleukin-2 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04562129 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedential studies involving Interleukin-2?

"Currently, 814 experiments related to Interleukin-2 are in progress. Of those studies, 89 have advanced to the third phase of trials. Although a majority of these experiments are located in Pittsburgh, Pennsylvania, there is also research being conducted at 43140 other sites worldwide."

Answered by AI

For what medical issues is Interleukin-2 commonly prescribed?

"Interleukin-2 is a viable treatment option for those who have undergone anti-angiogenic therapy, suffer from malignant neoplasms, and experience unresectable melanoma."

Answered by AI

Has Interleukin-2 been accepted by the FDA?

"Interlukin-2 has been rated a 2 on the Power team's scale, as there is evidence of its safety but no proof yet that it can be effective."

Answered by AI

Are there vacancies in this medical trial for people to participate?

"Affirmative. Clinicaltrials.gov records show that this clinical trial, which was initially published on September 24 2020, is still recruiting patients. A total of 29 participants are needed from a single site to complete the study."

Answered by AI

What is the aggregate figure of participants in this experiment?

"Affirmative, the clinicaltrial.gov portal indicates that this medical trial is actively recruiting participants. It was originally listed on September 24th 2020 and had its most recent update posted on September 30th 2022. 29 patients need to be enrolled at a single site."

Answered by AI
~3 spots leftby Sep 2024