Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma

Completed · Phase 1

Conditions studied: Melanoma

In brief

The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone

Key facts

Study ID

NCT01489059

Run by

Bristol-Myers Squibb

People needed

42

Starts

2011-12-01

Expected to finish

2014-06-01

Last updated by the study team

2014-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unresectable Stage III or Stage IV melanoma
• Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137
• Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
• Normal liver function tests

You may not qualify if…

• Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed
• Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded
• Autoimmune disease

Where it is running

• Oncology Research Associates, Pllc D/B/A — Scottsdale, Arizona, United States
• Ucla Hematology/Oncology. — Los Angeles, California, United States
• H. Lee Moffitt Cancer Center & Research Inst, Inc — Tampa, Florida, United States
• Indiana University Health Melvin And Bren Simon Cancer Center — Indianapolis, Indiana, United States
• University Of Louisville Medical Center, Inc., Dba — Louisville, Kentucky, United States
• Portland Providence Medical Center — Portland, Oregon, United States
• Md Anderson Can Cnt — Houston, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Local Institution — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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