HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma (PROCLIVITY 02)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
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
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
- One-year OS in the ITT population in each treatment arm [ Time Frame: One Year ]
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|
|Principal Investigator:||Sapna Patel, MD||MD Anderson|
|Principal Investigator:||William Sharfman, MD||Johns Hopkins University|
|Principal Investigator:||James Lowder, MD||Prometheus Labs|