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

• ClinicalTrials.gov Identifier: NCT01856023
• Recruitment Status: Terminated
• First Posted: May 17, 2013
• Last Update Posted: December 3, 2020
• Sponsor: Clinigen, Inc.
• Collaborators: M.D. Anderson Cancer Center; Johns Hopkins University
• Information provided by (Responsible Party): Clinigen, Inc.

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
Metastatic Melanoma	Drug: High Dose Interleukin-2; Drug: Ipilimumab	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 (Clinical Trial)
• 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 2013
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Arizona

The University of Arizona Cancer Center

Tucson, Arizona, United States, 85724

United States, California

Moores UCSD Cancer Center

La Jolla, California, United States, 92093

United States, Florida

MSMC Research Program

Miami Beach, Florida, United States, 33140

United States, Illinois

Oncology Specialists, SC

Park Ridge, Illinois, United States, 60068

United States, Iowa

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States, 52242

United States, Maryland

Johns Hopkins Medicine

Lutherville, Maryland, United States, 21093

United States, Michigan

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

United States, Nebraska

Nebraska Cancer Specialists, Midwest Cancer Center - Legacy

Omaha, Nebraska, United States, 68130

United States, New York

Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center

New York, New York, United States, 10032

United States, North Carolina

Duke University Health System

Durham, North Carolina, United States, 27710

United States, Ohio

The Christ Hospital

Cincinnati, Ohio, United States, 45219

United States, Texas

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

More Information

• Responsible Party: Clinigen, Inc.
• ClinicalTrials.gov Identifier: NCT01856023
• Other Study ID Numbers: 12PLK02
• First Posted: May 17, 2013
• Last Update Posted: December 3, 2020
• Last Verified: June 2019

Keywords provided by Clinigen, Inc.:

melanoma; metastatic; skin cancer; Stage IV; interleukin-2

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Aldesleukin; Ipilimumab; Interleukin-2; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immune Checkpoint Inhibitors; Molecular Mechanisms of Pharmacological Action; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents