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Urelumab

Phase 1

B-Cell Malignancies | Monoclonal antibody | Other |Bristol-Myers Squibb Company|Last Updated: Mar 31, 2017

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 Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01775631Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins LymphomaPHASE1 COMPLETED 47 — — Mar 1, 2013Aug 1, 2016Mar 31, 201715 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities
Up to 60 days after last dose of Urelumab
Secondary Endpoints
Efficacy-Antitumor Activity of Urelumab in combination with Rituximab as measured by best overall response, progression-free survival, time to response, and duration of response
Up to approximately 3 years
Maximum observed serum concentration (Cmax) of Urelumab and Rituximab
12 time points up to Day 60 of Follow-up
Time of maximum observed serum concentration (Tmax) of Urelumab
12 time points up to Day 60 of Follow-up
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm -1 - Urelumab + RituximabEXPERIMENTALUrelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
Arm 1 - Urelumab + RituximabEXPERIMENTALUrelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
Interventions
NameTypeDescription
UrelumabBIOLOGICAL -
RituximabBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Clinical diagnosis of relapsed/refractory B-cell Malignancies (B-Non-Hodgkins Lymphoma (NHL)) per International Workshop Group (IWG) * Progressed or refractory to at least 1...

Countries:United States
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