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BMS-986178

Phase 1

Advanced Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 25, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment166
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02737475An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have SpreadPHASE1 COMPLETED 166Jun 17, 2016Nov 2, 2020Jan 25, 202222 United States, Canada +4
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Study Endpoints
Primary Endpoints
The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
From first dose to 28 days after first dose

The number of participants experiencing dose-limiting toxicities (DLTs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. DLTs are defined based on the incidence, severity, and duration of adverse events (AEs) for which no clear alternative cause is identified. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.

The Number of Participants Experiencing Adverse Events (AEs)
From first dose to 100 days after last dose (up to approximately 2.5 years)

The number of participants experiencing adverse events (AEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.

The Number of Participants Experiencing Serious Adverse Events (SAEs)
From first dose to 100 days after last dose (up to approximately 2.5 years)

The number of participants experiencing serious adverse events (SAEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.

The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
From first dose to 100 days after last dose (up to approximately 2.5 years)

The number of participants experiencing adverse events (AEs) leading to discontinuation of study drug to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.

The Number of Participant Deaths
From first dose to study completion (up to approximately 4 years 5 months)

The number of deaths in each arm to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.

The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
From baseline to 100 days after last dose (up to approximately 2.5 years)

The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time

The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
From baseline to 100 days after last dose (up to approximately 2.5 years)

The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time

The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
From baseline to 100 days after last dose (up to approximately 2.5 years)

The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time

Secondary Endpoints
Objective Response Rate (ORR)
From baseline up to approximately 2.5 years
Duration of Response (DOR)
From baseline up to approximately 2.5 years
Progression Free Survival (PFS) Rate at 24 Weeks
24 weeks after first dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose EscalationEXPERIMENTAL* BMS-986178 at specified doses at specified intervals * Enrollment is closed for this arm
Part 2: Dose Escalation and ExpansionEXPERIMENTAL* BMS-986178 in combination with Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 3: Dose Escalation and ExpansionEXPERIMENTAL* BMS-986178 in combination with Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 4: Dose Schedule and ExplorationEXPERIMENTAL* BMS-986178/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 5: Dose Schedule and ExplorationEXPERIMENTAL* BMS-986178/Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 6: Dose Safety and ExpansionEXPERIMENTAL* BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 7: Dose Safety and ExpansionEXPERIMENTAL* BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 8: Dose ExplorationEXPERIMENTAL* BMS-986178/Nivolumab with tetanus vaccine at specified doses and interval * Enrollment is closed for this arm
Part 9: Dose ExplorationEXPERIMENTAL* BMS-986178/Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 1) at specified doses at specified intervals OR Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 2) at specified doses at specified intervals * Enrollment is open for this arm \[Tumor type triple negative breast cancer (TNBC)\]
Interventions
NameTypeDescription
BMS-986178DRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
IpilimumabDRUGSpecified dose on specified days
Tetanus vaccineBIOLOGICALSpecified dose on specified days
DPV-001 vaccineBIOLOGICALDPV-001 (UbiLT3 and UbiLT6): Specified dose on specified days
CyclophosphamideDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: For Part 9 (only arm open for enrollment): * Stage IV metastatic or unresectable triple negative breast cancer (TNBC) with zero or one prior systemic therapie...

Countries:United StatesCanadaIsraelItalyNetherlandsSpain
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