Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Prometheus Laboratories
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Johns Hopkins University
Information provided by (Responsible Party):
Prometheus Laboratories
ClinicalTrials.gov Identifier:
NCT01856023
First received: May 10, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Metastatic Melanoma
Drug: High Dose Interleukin-2
Drug: Ipilimumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Prometheus Laboratories:

Primary Outcome Measures:
  • One-year OS in the ITT population in each treatment arm [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856023

Contacts
Contact: Theresa Luna 858-882-8058 tluna@prometheuslabs.com

Locations
United States, Arizona
The University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Jacque Newbrey    520-626-0544    jnewbrey@azcc.arizona.edu   
Principal Investigator: Lee Cranmer, MD         
United States, California
Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Suzanna Lee, MPH    858-822-4171    sml012@ucsd.edu   
Principal Investigator: Greg Daniels, MD, PhD         
United States, Florida
MSMC Research Program Recruiting
Miami Beach, Florida, United States, 33140
Contact: Yvonne Nunez    305-674-2625    yenrique@msmc.com   
Principal Investigator: Jose Lutzky, MD         
United States, Illinois
Oncology Specialists, SC Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Anuradha Chakrabarty    847-268-8574    achakrabarty@oncmed.net   
Principal Investigator: Sigrun Hallmeyer, MD         
United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Marian Andersen    319-356-2324    marian-andersen@uiowa.edu   
Principal Investigator: Mohammed Milhem, MD         
United States, Maryland
Johns Hopkins Medicine Recruiting
Lutherville, Maryland, United States, 21093
Contact: JoAnn Santmyer, RN, BSN    410-583-2970    jsantmy1@jhmi.edu   
Principal Investigator: William H. Sharfman, MD, FACP         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Marianne Garcia    313-576-9386    garciam@karmanos.org   
Principal Investigator: Lawrence Flaherty, MD         
United States, Nebraska
Nebraska Cancer Specialists, Midwest Cancer Center - Legacy Recruiting
Omaha, Nebraska, United States, 68130
Contact: Korinne Riley, RN, MSN    402-691-6974    kriley@nebraskacancer.com   
Principal Investigator: Ralph Hauke, MD         
United States, New York
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Amiya R. Vaz    212-305-1317    av2454@columbia.edu   
Principal Investigator: Bret Taback, MD         
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Kristen Linney    919-684-8239    k.linney@duke.edu   
Contact: Rob Holeman    919-684-8239    rob.holeman@duke.edu   
Principal Investigator: Michael Morse, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Brandon Fletcher    513-321-3777    brandon.fletcher@thechristhospital.com   
Principal Investigator: Philip Leming, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Gener Balmes, Primary Research Nurse    713-792-4153    GCBalmes@mdanderson.org   
Principal Investigator: Sapna Patel, MD         
Sponsors and Collaborators
Prometheus Laboratories
M.D. Anderson Cancer Center
Johns Hopkins University
Investigators
Principal Investigator: Sapna Patel, MD MD Anderson
Principal Investigator: William Sharfman, MD Johns Hopkins University
Principal Investigator: James Lowder, MD Prometheus Labs
  More Information

No publications provided

Responsible Party: Prometheus Laboratories
ClinicalTrials.gov Identifier: NCT01856023     History of Changes
Other Study ID Numbers: 12PLK02
Study First Received: May 10, 2013
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Prometheus Laboratories:
melanoma
metastatic
skin cancer
Stage IV
interleukin-2

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Interleukin-2
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Aldesleukin
Analgesics
Analgesics, Non-Narcotic
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014