HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Clinigen, Inc.
Study ID
NCT01856023
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High Dose Interleukin-2 — DRUG
  • Ipilimumab — DRUG

Study Details

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.

Key Dates

Start date
May 31, 2013
Status verified
Mar 2023
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Treatment Arm 2
    Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.

Primary Outcome Measure

Estimated One-year OS in the Evaluable Population in Each Treatment Arm Separately [ Time Frame: 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. ]

Locations (12)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer CenterTucsonArizona85724-
Moores UCSD Cancer CenterLa JollaCalifornia92093-
MSMC Research ProgramMiami BeachFlorida33140-
Oncology Specialists, SCPark RidgeIllinois60068-
University of Iowa Hospitals & ClinicsIowa CityIowa52242-
Johns Hopkins MedicineLuthervilleMaryland21093-
Karmanos Cancer InstituteDetroitMichigan48201-
Nebraska Cancer Specialists, Midwest Cancer Center - LegacyOmahaNebraska68130-
Columbia University Medical Center, Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Duke University Health SystemDurhamNorth Carolina27710-
The Christ HospitalCincinnatiOhio45219-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Tucson, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
The University of Arizona Cancer Center· Tucson, AZMoores UCSD Cancer Center· La Jolla, CAMSMC Research Program· Miami Beach, FLOncology Specialists, SC· Park Ridge, ILUniversity of Iowa Hospitals & Clinics· Iowa City, IAJohns Hopkins Medicine· Lutherville, MD

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