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BMS-986178

Phase 1

Advanced Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2022

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment166

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986178 · 1 trial · 1 indication

Phase 1 1
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 SpreadAdvanced Cancer
COMPLETED166 Analytics
PHASE1COMPLETED
An 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 Spread
Advanced CancerUnlock trial analytics

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 to 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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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about BMS-986178

What is BMS-986178 used for?

BMS-986178 is an investigational small molecule being studied for the treatment of advanced cancer. It is being evaluated in patients with solid cancers that are advanced or have spread. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes BMS-986178?

BMS-986178 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational oncology treatment.

What phase is BMS-986178 in?

BMS-986178 is in Phase 1 clinical development. The drug is being studied as an investigational immuno-therapy for advanced solid cancers. It remains in early-stage clinical testing and has not received regulatory approval for any indication.

What clinical trials is BMS-986178 in?

BMS-986178 has been studied in clinical trial NCT02737475, a Phase 1 study evaluating the drug by itself or in combination with nivolumab and/or ipilimumab in participants with solid cancers that are advanced or have spread. This trial enrolled 166 participants and has been completed.

Is BMS-986178 the same as nivolumab or ipilimumab?

No, BMS-986178 is a distinct investigational drug. It is being studied alone and in combination with nivolumab and/or ipilimumab in clinical trials. The trial NCT02737475 evaluated BMS-986178 by itself or in combination with these other agents in patients with advanced solid cancers.