Clincosm LogoSign in Get a demo

PROCLIVITY02: HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma

Sponsor
Clinigen, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01856023
Collaborator
M.D. Anderson Cancer Center (Other), Johns Hopkins University (Other)
29
Enrollment
12
Locations
2
Arms
26
Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

All patients will receive IL-2 at 600,000 international units per kilogram (kg) by intraveneous bolus (IVB) every 8 hours for 14 planned doses with an additional cycle 14 days after the first. Ipilimumab 3mg/kg IV infusion Q3 weeks.

Study Design

Study Type:
Interventional
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 1, 2013
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

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 [One Year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 The University of Arizona Cancer Center Tucson Arizona United States 85724
    2 Moores UCSD Cancer Center La Jolla California United States 92093
    3 MSMC Research Program Miami Beach Florida United States 33140
    4 Oncology Specialists, SC Park Ridge Illinois United States 60068
    5 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
    6 Johns Hopkins Medicine Lutherville Maryland United States 21093
    7 Karmanos Cancer Institute Detroit Michigan United States 48201
    8 Nebraska Cancer Specialists, Midwest Cancer Center - Legacy Omaha Nebraska United States 68130
    9 Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    10 Duke University Health System Durham North Carolina United States 27710
    11 The Christ Hospital Cincinnati Ohio United States 45219
    12 MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Clinigen, Inc.
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinigen, Inc.
    ClinicalTrials.gov Identifier:
    NCT01856023
    Other Study ID Numbers:
    • 12PLK02
    First Posted:
    May 17, 2013
    Last Update Posted:
    Dec 3, 2020
    Last Verified:
    Jun 1, 2019
    Keywords provided by Clinigen, Inc.
    melanoma
    metastatic
    skin cancer
    Stage IV
    interleukin-2
    Additional relevant MeSH terms:
    Melanoma
    Aldesleukin
    Ipilimumab
    Interleukin-2

    Study Results

    No Results Posted as of Dec 3, 2020