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

Primary Purpose

Metastatic Melanoma

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
High Dose Interleukin-2
Ipilimumab
Sponsored by
Clinigen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring melanoma, metastatic, skin cancer, Stage IV, interleukin-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Arizona Cancer Center
  • Moores UCSD Cancer Center
  • MSMC Research Program
  • Oncology Specialists, SC
  • University of Iowa Hospitals & Clinics
  • Johns Hopkins Medicine
  • Karmanos Cancer Institute
  • Nebraska Cancer Specialists, Midwest Cancer Center - Legacy
  • Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
  • Duke University Health System
  • The Christ Hospital
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment Arm 1

Treatment Arm 2

Arm Description

Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab.

Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.

Outcomes

Primary Outcome Measures

One-year OS in the ITT population in each treatment arm
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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2013
Last Updated
December 1, 2020
Sponsor
Clinigen, Inc.
Collaborators
M.D. Anderson Cancer Center, Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01856023
Brief Title
HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
Acronym
PROCLIVITY02
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 Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
slow accrual & early closure
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinigen, Inc.
Collaborators
M.D. Anderson Cancer Center, Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
melanoma, metastatic, skin cancer, Stage IV, interleukin-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm 1
Arm Type
Active Comparator
Arm Description
Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab.
Arm Title
Treatment Arm 2
Arm Type
Active Comparator
Arm Description
Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
Intervention Type
Drug
Intervention Name(s)
High Dose Interleukin-2
Other Intervention Name(s)
Aldesleukin, Proleukin, interleukin
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, anti-CTLA4
Primary Outcome Measure Information:
Title
One-year OS in the ITT population in each treatment arm
Description
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.
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sapna Patel, MD
Organizational Affiliation
MD Anderson
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Sharfman, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Lowder, MD
Organizational Affiliation
Prometheus Labs
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
MSMC Research Program
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Oncology Specialists, SC
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Johns Hopkins Medicine
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Nebraska Cancer Specialists, Midwest Cancer Center - Legacy
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma

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