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HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma

NCT01856023 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-12-05

Study results available
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Summary

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.

Conditions

Interventions

DRUG

High Dose Interleukin-2

DRUG

Ipilimumab

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Clinigen, Inc.

    lead INDUSTRY

Principal Investigators

  • Sapna Patel, MD · MD Anderson

  • William Sharfman, MD · Johns Hopkins University

  • James Lowder, MD · Prometheus Labs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01856023 on ClinicalTrials.gov