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

November 14, 2023 updated by: Clinigen, Inc.

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: "HD IL-2 first, then ipilimumab" 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: Ipilimumab first then HD IL-2 Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

All patients will receive IL-2 at 600,000 international units per kilogram (kg) by intravenous bolus (IVB) every 8 hours for up to 14 planned doses with an additional cycle 14 days after the first.

Ipilimumab 3mg/kg IV infusion Q3 weeks up to 4 doses4 doses A 3-6 week interval been the administration of the two drugs to allow for resolution of treatment-related toxicities.

If corticosteroids were required during Ipilimumab administration, a 2-week period from discontinuation of steroid treatment to start of HD IL-2.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Ipilimumab
Other Names:
  • Yervoy
  • anti-CTLA4
Drug: High Dose Interleukin-2
Other Names:
  • Proleukin
  • Aldesleukin
  • interleukin
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: Ipilimumab
Other Names:
  • Yervoy
  • anti-CTLA4
Drug: High Dose Interleukin-2
Other Names:
  • Proleukin
  • Aldesleukin
  • interleukin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated One-year OS in the Evaluable Population in Each Treatment Arm Separately
Time Frame: start of first treatment to date of death from any cause and patients alive at their last evaluation date were censored up to 1 year.

evaluable patients who received at least 50% of both research drugs and had their disease re-evaluated after baseline; defined in days for the start of the first treatment to death.

percent of patients alive at 1 year; estimates were assessed using Kaplan-Meier method for the entire subject population for each treatment arm separately.
start of first treatment to date of death from any cause and patients alive at their last evaluation date were censored up to 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: 5-11 weeks, 13-19 Weeks, 24-30 weeks and 1 year
duration of time (in Days) from start of the first treatment to the time of objective disease progression or death at one year. The immune-related response criteria (irRC) determined based on tumor burden calculated on the WHO method of multiplying the perpendicular dimensions of all lesions are summed to obtain the tumor burden. The total tumor burden + SPD (index lesions) + SPD (new measurable lesions) Based on CT scans and Physical exam at designated timepoints. CR- Disappearance of all known disease; PR>/equal to decrease; SD Neither CR or PD; PD 25%increase; new lesion.
5-11 weeks, 13-19 Weeks, 24-30 weeks and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinigen, Inc.

Collaborators

Johns Hopkins University
M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Sapna Patel, MD, MD Anderson
  • Principal Investigator: William Sharfman, MD, Johns Hopkins University
  • Principal Investigator: James Lowder, MD, Prometheus Labs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimated)

May 17, 2013

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12PLK02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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