Clinical trial NCT01856023: HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Metastatic Melanoma
Keywords: melanoma
metastatic
skin cancer
Stage IV
interleukin-2
Lead sponsor: Clinigen, Inc.
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
name: Johns Hopkins University
First posted: 2013-05-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: assess the sequenced use of HD IL2 and IPI in metastatic melanoma patients
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Estimated One-year OS in the Evaluable Population in Each Treatment Arm Separately
timeFrame: 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:
measure: Progression-free Survival
timeFrame: 5-11 weeks, 13-19 Weeks, 24-30 weeks and 1 year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: Miami Beach
country: United States
facility: MSMC Research Program
state: Florida
city: Park Ridge
country: United States
facility: Oncology Specialists, SC
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Lutherville
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Omaha
country: United States
facility: Nebraska Cancer Specialists, Midwest Cancer Center - Legacy
state: Nebraska
city: New York
country: United States
facility: Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: MD Anderson
name: Sapna Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: William Sharfman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prometheus Labs
name: James Lowder, MD
role: PRINCIPAL_INVESTIGATOR
References: