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

May 10, 2013
May 28, 2014
May 2013
January 2018   (final data collection date for primary outcome measure)
One-year OS in the ITT population in each treatment arm [ Time Frame: One Year ] [ Designated as safety issue: No ]
OS at one year in the Evaluable for Objective Response population [ Time Frame: One Year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01856023 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy) in Patients With Metastatic Melanoma

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Melanoma
  • Drug: High Dose Interleukin-2
    Other Names:
    • Aldesleukin
    • Proleukin
    • interleukin
  • Drug: Ipilimumab
    Other Names:
    • Yervoy
    • anti-CTLA4
  • 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.
    Interventions:
    • Drug: High Dose Interleukin-2
    • Drug: Ipilimumab
  • Active Comparator: Treatment Arm 2
    Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
    Interventions:
    • Drug: High Dose Interleukin-2
    • Drug: Ipilimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2018
January 2018   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Theresa Luna 858-882-8058 tluna@prometheuslabs.com
United States
 
NCT01856023
12PLK02
Yes
Prometheus Laboratories
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
Prometheus Laboratories
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP