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

NCT04562129 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV
  • Inoperable Disease

Interventions

DRUG

Interleukin-2

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

DRUG

Ipilimumab

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

DRUG

Nivolumab

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

Sponsors & Collaborators

  • Clinigen, Inc.

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Ahmad Tarhini, MD, PhD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2026-07-31
Completion
2029-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04562129 on ClinicalTrials.gov