Clinical trialNCT01856023TerminatedPhase 4Interventional

HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma

SponsorClinigen, Inc.Enrollment29Metastatic Melanoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy. Treatment Arm 1: "HD IL-2 first, then ipilimumab" Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab. Treatment Arm 2: Ipilimumab first then HD IL-2 Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

James Lowder, MD
Prometheus Labs
Principal Investigator
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Sapna Patel, MD
MD Anderson
Principal Investigator
clinicaltrials.gov ↗
William Sharfman, MD
Johns Hopkins University
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

the University of Arizona Cancer Center
Tucson, Arizona, United States
Moores Ucsd Cancer Center
La Jolla, California, United States
Msmc Research Program
Miami Beach, Florida, United States
Oncology Specialists, Sc
Park Ridge, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Johns Hopkins Medicine
Lutherville, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Nebraska Cancer Specialists, Midwest Cancer Center - Legacy
Omaha, Nebraska, United States
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
the Christ Hospital
Cincinnati, Ohio, United States
Md Anderson Cancer Center
Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

High Dose Interleukin-2Ipilimumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2013
Primary completion: 31 Jul 2015
Completion: 31 Jul 2015
Last update posted: 5 Dec 2023
Registered enrollment: 29
Registry id: NCT01856023

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.