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Lirilumab

Phase 1

Advanced Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 10, 2022

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 Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03203876A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid TumorsPHASE1 COMPLETED 10 — — Jul 14, 2017Aug 6, 2020Mar 10, 20222 Japan
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Study Endpoints
Primary Endpoints
Incidence of dose-limiting toxicity (DLT)
Up to two years

To assess the safety and tolerability of lirilumab in combination with nivolumab

Incidence of adverse events (AEs)
Up to two years

To assess the safety and tolerability of lirilumab in combination with nivolumab

Incidence of serious adverse events (SAEs)
Up to two years

To assess the safety and tolerability of lirilumab in combination with nivolumab

Incidence of death
Up to two years

To assess the safety and tolerability of lirilumab in combination with nivolumab

Frequency of laboratory test toxicity grade shifting from baseline
Up to two years

To assess the safety and tolerability of lirilumab in combination with nivolumab

Incidence of AEs leading to discontinuation
Up to two years

To assess the safety and tolerability of lirilumab in combination with nivolumab

Secondary Endpoints
Incidence of dose-limiting toxicity (DLT)
Up to two years
Incidence of adverse events (AEs)
Up to two years
Incidence of serious adverse events (SAEs)
Up to two years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part One Combination TherapyEXPERIMENTALLirilumab and Nivolumab
Part 2 Combination TherapyEXPERIMENTALLirilumab, Nivolumab and Ipilimumab
Interventions
NameTypeDescription
LirilumabBIOLOGICALSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
IpilimumabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com * Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable) * Presence of at least 1 ...

Countries:Japan
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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