← Back to Search

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

Must not have

Clinically significant cardiovascular or cerebrovascular disease

Active brain metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I am over 50 or have a history of lung issues or smoking, and need lung function tests.

Select...

My melanoma is confirmed to be at an advanced stage and cannot be removed by surgery.

Select...

I have no heart conditions like heart failure or recent heart attacks.

Select...

I am fully active or can carry out light work.

Select...

My cancer progressed after treatment with nivolumab or pembrolizumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have serious heart or brain blood vessel problems.

Select...

I have active cancer spread to my brain.

Select...

I haven't had melanoma treatment or radiation in the last 3 weeks and have recovered from any past treatments.

Select...

I have a history of adrenal insufficiency.

Select...

I am currently on medication for an autoimmune disorder or to suppress my immune system.

Select...

I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response Rate

Secondary study objectives

Overall Survival

Progression Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~690

Ipilimumab

2015

Completed Phase 3

~3420