RecruitingPhase 2NCT04562129

IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients

A Phase II Study of High Dose Bolus IL2 in Combination With Low Dose Ipilimumab Followed Sequentially by Nivolumab in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

29 participants

Start Date

Sep 24, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out if the administration of Interleukin-2 concurrently with ipilimumab followed by Nivolumab will result in improved anti-cancer activity and if it is effective for advanced melanoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of immunotherapy drugs — interleukin-2 (IL-2), ipilimumab, and nivolumab — for patients with advanced melanoma (skin cancer) whose disease progressed after treatment with a PD-1 checkpoint inhibitor (such as nivolumab or pembrolizumab). **You may be eligible if...** - You have been diagnosed with Stage III (inoperable) or Stage IV melanoma - Your melanoma has gotten worse despite previous treatment with a PD-1 immunotherapy drug - You have not had active brain metastases recently (or they have been treated and are stable) - You have not received cancer treatment or radiation in the past 3 weeks - You have recovered fully from any prior surgery **You may NOT be eligible if...** - Your cancer has not previously been treated with a PD-1 checkpoint inhibitor - You have active, untreated brain metastases - You have significant heart disease or other major organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInterleukin-2

High dose interleukin-2 (HD IL2) administered week 1 and 4 of each course (approximately 12 weeks)

DRUGIpilimumab

Low dose Ipilimumab given at time of HD IL2 administration on day 1 of the first 2 cycles of each course.

DRUGNivolumab

Nivolumab will be given at a dose of 480 mg IV week 7 of each course.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT04562129


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