Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
A Phase I Dose Escalation Study of BMS-982470 (Recombinant Interleukin 21, rIL-21) in Combination With Ipilimumab in Subjects With Unresectable Stage III or Stage IV Melanoma
1 other identifier
interventional
42
2 countries
9
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2011
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 7, 2011
CompletedFirst Posted
Study publicly available on registry
December 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedAugust 29, 2014
August 1, 2014
2.5 years
December 7, 2011
August 28, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Part1 (Dose Escalation): The Maximum tolerated dose (MTD) of BMS-982470 using 2 distinct schedules when administered in combination with Ipilimumab
Based on the dose-limiting toxicity (DLT) rate
Within the first 63 days
Part 2 (Cohort Escalation): Safety and tolerability of the MTD dose for each of the schedules
Based on medical review of AE reports and the results of vital sign measurements, physical examinations, medical history, and clinical laboratory tests
84 days on treatment
Secondary Outcomes (11)
Efficacy of BMS-982470 in combination with Ipilimumab as measured by objective response
Baseline (Day 1), End of Treatment (EOT) [3 weeks after last dose of Ipilimumab], 3 and 6 months Follow-up
Area under the serum concentration-time curve from time zero to the last quantifiable concentration [AUC(0-T)] of BMS-982470 and Ipilimumab
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] of BMS-982470 and Ipilimumab
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-982470 and Ipilimumab
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
The maximum observed serum concentration (Cmax) of BMS-982470 and Ipilimumab
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
- +6 more secondary outcomes
Study Arms (5)
Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
EXPERIMENTALDose Escalation
Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
EXPERIMENTALDose Escalation
Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
EXPERIMENTALCohort Expansion
Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
EXPERIMENTALCohort Expansion
Part 2 - Arm 3: Ipilimumab monotherapy
ACTIVE COMPARATORCohort Expansion
Interventions
Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response
Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Oncology Research Associates, Pllc D/B/A
Scottsdale, Arizona, 85258, United States
Ucla Hematology/Oncology.
Los Angeles, California, 90095, United States
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, Florida, 33612, United States
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
University Of Louisville Medical Center, Inc., Dba
Louisville, Kentucky, 40202, United States
Portland Providence Medical Center
Portland, Oregon, 97213, United States
Md Anderson Can Cnt
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Local Institution
San Juan, 00927, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2011
First Posted
December 9, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
August 29, 2014
Record last verified: 2014-08