Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors
A Phase 1 Dose Escalation Study of BMS-982470 (Recombinant Interleukin-21, rIL-21) in Combination With BMS-936558 (Anti-PD-1) in Subjects With Advanced or Metastatic Solid Tumors
1 other identifier
interventional
33
1 country
5
Brief Summary
The purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.
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 Jun 2012
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 6, 2015
February 1, 2015
2.5 years
June 26, 2012
March 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Safety, as measured by the rate of adverse events and serious adverse events
Approximately up to 4.5 years
Secondary Outcomes (2)
Efficacy as measured by tumor assessment (RECIST)
Week 6 of for the first 4 cycles, Week 6 of alternate cycle starting with cycle 6, End of Treatment (2 years) and approximately every 12 weeks during follow-up (approximately 1 year)
Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558
Up to 2 years + 100 days post-treatment follow-up
Study Arms (3)
Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558
EXPERIMENTALDose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558
EXPERIMENTALDose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558
EXPERIMENTALCohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
Interventions
Eligibility Criteria
You may qualify if:
- All subjects will have locally advanced or metastatic solid tumors
- For Part 2 (Cohort Expansion):
- Tumor types will be restricted to clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer (NSCLC), and melanoma
- At least 1 lesion with measurable disease
- Only subjects with tumor samples that are PD-L1 positive or negative are eligible
You may not qualify if:
- Uncontrolled central nervous system (CNS) or leptomeningeal metastasis
- Inadequate liver or kidney function
- History of autoimmune Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Oncology Research Associates, Pllc D/B/A
Scottsdale, Arizona, 85258, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
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
June 26, 2012
First Posted
June 28, 2012
Study Start
June 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 6, 2015
Record last verified: 2015-02