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HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma (PROCLIVITY 02)

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ClinicalTrials.gov Identifier: NCT01856023
Recruitment Status : Terminated (A shift in the melanoma treatment landscape adversely affected accrual & early closure)
First Posted : May 17, 2013
Last Update Posted : July 17, 2015
Information provided by (Responsible Party):

Study Description
Brief 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: 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: Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.

HD IL-2 and ipilimumab dosing regimens will comply with the instructions in the most current package inserts, institutional guidelines, and medical expertise of the treating physician. However, neither the ipilimumab nor the HD IL-2 should be dose reduced. If necessary, doses should be either held or permanently discontinued (per package insert instructions). Protocol specific dosing guidance is included in the 12PLK02 Work Instructions.

Patients will be scheduled for four response assessments. Response assessment timing should be targeted to fall within the following time points: between 5-11 weeks, 13-19 weeks, 24-30 weeks and one year after initiating therapy in either treatment arm. Timing of the response assessments may be adjusted to facilitate clinical procedures and treatment decisions.

Patient treatment tolerability and safety events will be monitored and managed while enrolled in the 12PLK02 study. Patients who receive HD IL-2 in the 12PLK02 study will be enrolled in the PROCLAIM study (Registry Protocol 10PLK13) for the collection of long-term assessment data, including response and disease status and treatment decisions. Patient treatment data will be entered in to the PROCLAIM database, for a minimum target of 2 years and potentially up to 5 years, after the patient completes the 12PLK02 study.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Drug: High Dose Interleukin-2 Drug: Ipilimumab Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy) in Patients With Metastatic Melanoma
Study Start Date : May 2013
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Treatment Arm 1
Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab.
Drug: High Dose Interleukin-2
Other Names:
  • Aldesleukin
  • Proleukin
  • interleukin
Drug: Ipilimumab
Other Names:
  • Yervoy
  • anti-CTLA4
Active Comparator: Treatment Arm 2
Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
Drug: High Dose Interleukin-2
Other Names:
  • Aldesleukin
  • Proleukin
  • interleukin
Drug: Ipilimumab
Other Names:
  • Yervoy
  • anti-CTLA4

Outcome Measures

Primary Outcome Measures :
  1. One-year OS in the ITT population in each treatment arm [ Time Frame: One Year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients 18 years or older
  • Confirmed and measurable metastatic melanoma with at least one measurable lesion for evaluation of response
  • Meets the requirements for HD IL-2 therapy per Institutional guidelines
  • Meets the requirements for ipilimumab therapy per Institutional guidelines
  • Treatment naïve or has received only one systemic therapy apart from adjuvant therapy.
  • At least 4 weeks since last adjuvant therapy or other cancer treatment
  • Willing and able to give informed consent and participate in study procedures as described in the 12PLK02 and 10PLK13 protocols. Patients consented for 12PLK02 will also be asked to participate in the 10PLK13 PROCLAIM registry study.

Exclusion Criteria:

  • Patients with known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) or other infectious hepatitis
  • Pregnant, nursing or planning to become pregnant
  • Untreated brain metastases. (Brain metastases that have been treated, which no longer require corticosteroid therapy and are without progression by MRI at least 6 weeks after definitive therapy are acceptable.)
  • Received prior ipilimumab therapy (Prior Adjuvant Ipilimumab and Adjuvant Interferon are permitted with a minimum 4 week washout)
  • Received prior HD IL-2 therapy.
  • Received investigational drug within 30 days prior to study dosing. Patients may participate in non-interventional or observational clinical studies, including the 10PLK13 PROCLAIM registry study.
  • Concomitant disease or condition that would interfere with the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856023

United States, Arizona
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
United States, Florida
MSMC Research Program
Miami Beach, Florida, United States, 33140
United States, Illinois
Oncology Specialists, SC
Park Ridge, Illinois, United States, 60068
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins Medicine
Lutherville, Maryland, United States, 21093
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Nebraska
Nebraska Cancer Specialists, Midwest Cancer Center - Legacy
Omaha, Nebraska, United States, 68130
United States, New York
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Prometheus Laboratories
M.D. Anderson Cancer Center
Johns Hopkins University
Principal Investigator: Sapna Patel, MD MD Anderson
Principal Investigator: William Sharfman, MD Johns Hopkins University
Principal Investigator: James Lowder, MD Prometheus Labs
More Information

Responsible Party: Prometheus Laboratories
ClinicalTrials.gov Identifier: NCT01856023     History of Changes
Other Study ID Numbers: 12PLK02
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015

Keywords provided by Prometheus Laboratories:
skin cancer
Stage IV

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents