HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma

NCT01856023 | Terminated Phase 4 Results DMC

• 1 other identifier: 12PLK02
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 12

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: "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.

Conditions

Metastatic Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Estimated One-year OS in the Evaluable Population in Each Treatment Arm Separately

  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 Outcomes (1)

• Progression-free Survival

  5-11 weeks, 13-19 Weeks, 24-30 weeks and 1 year

Study Arms (2)

Treatment Arm 1

ACTIVE COMPARATOR

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; Drug: Ipilimumab

Treatment Arm 2

ACTIVE COMPARATOR

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

Drug: High Dose Interleukin-2; Drug: Ipilimumab

Interventions

High Dose Interleukin-2 DRUG

Also known as: Aldesleukin, Proleukin, interleukin

Treatment Arm 1; Treatment Arm 2

Ipilimumab DRUG

Also known as: Yervoy, anti-CTLA4

Treatment Arm 1; Treatment Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinigen, Inc.: lead
• M.D. Anderson Cancer Center: collaborator
• Johns Hopkins University: collaborator

Study Sites (12)

The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

MSMC Research Program

Miami Beach, Florida, 33140, United States

Location

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins Medicine

Lutherville, Maryland, 21093, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Nebraska Cancer Specialists, Midwest Cancer Center - Legacy

Omaha, Nebraska, 68130, United States

Location

Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Duke University Health System

Durham, North Carolina, 27710, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis; Skin Neoplasms

Interventions

Interleukin-2; aldesleukin; Interleukins; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Limitations and Caveats

This study enrollment planned for 50 in each arm; but ended early 29 pts enrolled due to change in treatment options; the purpose of the study was to determine which sequence of approved therapy was more effective and safe; this was not a planned cross-over study complete data collection and final summary is limited due to limited data available Due to sponsor changes, and databases are no longer available.

Results Point of Contact

• Title: Head of Medical Affairs
• Organization: Clinigen

nancy.gregory@clinigengroup.com

8323263256

Study Officials

• Sapna Patel, MD

  MD Anderson

  PRINCIPAL INVESTIGATOR

• William Sharfman, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• James Lowder, MD

  Prometheus Labs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: assess the sequenced use of HD IL2 and IPI in metastatic melanoma patients

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 17, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-03

Locations

US (12)