Status:
TERMINATED
HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
Lead Sponsor:
Clinigen, Inc.
Collaborating Sponsors:
M.D. Anderson Cancer Center
Johns Hopkins University
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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. I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01856023
Start Date
May 1 2013
End Date
July 1 2015
Last Update
December 5 2023
Active Locations (12)
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1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
3
MSMC Research Program
Miami Beach, Florida, United States, 33140
4
Oncology Specialists, SC
Park Ridge, Illinois, United States, 60068