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Denenicokin

Phase 1

Neoplasms by Site | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 6, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01629758Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid TumorsPHASE1 COMPLETED 33Jun 1, 2012Dec 1, 2014Mar 6, 20155 United States
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Study Endpoints
Primary Endpoints
Safety, as measured by the rate of adverse events and serious adverse events
Approximately up to 4.5 years
Secondary Endpoints
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558EXPERIMENTALDose 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-936558EXPERIMENTALDose 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-936558EXPERIMENTALCohort 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
NameTypeDescription
DenenicokinBIOLOGICAL -
NivolumabBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * 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 (cc...

Countries:United States
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