Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
NCT ID: NCT01489059
Last Updated: 2014-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2011-12-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
Dose Escalation
BMS-982470 (recombinant interleukin-21)
Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response
Ipilimumab
Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
Dose Escalation
BMS-982470 (recombinant interleukin-21)
Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response
Ipilimumab
Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
Cohort Expansion
BMS-982470 (recombinant interleukin-21)
Solution, Intravenous, Maximum tolerated dose from Part 1, daily for 5 days every 3 weeks (daily x 5), 12-16 weeks depending on response
Ipilimumab
Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
Cohort Expansion
BMS-982470 (recombinant interleukin-21)
Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response
Ipilimumab
Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
Part 2 - Arm 3: Ipilimumab monotherapy
Cohort Expansion
Ipilimumab
Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
Interventions
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BMS-982470 (recombinant interleukin-21)
Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response
BMS-982470 (recombinant interleukin-21)
Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response
BMS-982470 (recombinant interleukin-21)
Solution, Intravenous, Maximum tolerated dose from Part 1, daily for 5 days every 3 weeks (daily x 5), 12-16 weeks depending on response
BMS-982470 (recombinant interleukin-21)
Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response
Ipilimumab
Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
Ipilimumab
Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
Ipilimumab
Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded
* Autoimmune disease
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA220-007
Identifier Type: -
Identifier Source: org_study_id