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BMS-986416

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 9, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986416 · 1 trial · 1 indication

Phase 1 1
NCT04943900A Study of BMS-986416 With and Without Nivolumab in Select Solid TumorsAdvanced Solid Tumors
COMPLETED67 Analytics
PHASE1COMPLETED
A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
Advanced Solid Tumors
NCT0494390067
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Study Endpoints

Primary Endpoints

Incidence of Adverse Events (AEs)
Up to 100 days after the last treatment of study intervention(s)
Incidence of Serious Adverse Events (SAEs)
Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to discontinuation
Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to death
Up to 100 days after the last treatment of study intervention(s)
Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)
Up to 100 days after the last treatment of study intervention(s)

Secondary Endpoints

Maximum observed serum concentration (Cmax) of BMS-986416
Up to 100 days after the last treatment of study intervention(s)
Time of maximum observed serum concentration (Tmax) of BMS-986416
Up to 100 days after the last treatment of study intervention(s)
Trough observed serum concentration (Ctrough) of BMS-986416
Up to 100 days after the last treatment of study intervention(s)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A: Monotherapy (BMS-986416)EXPERIMENTAL -
Part 1B: Combination Therapy (BMS-986416 + Nivolumab)EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986416DRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor * Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), He...

Countries:United StatesArgentinaBelgiumCanadaChileJapanNetherlands
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about BMS-986416

What is BMS-986416 used for?

BMS-986416 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is being evaluated in a Phase 1 clinical trial, both alone and in combination with nivolumab, in patients with select solid tumors. The drug is not yet approved and remains in clinical development.

Who makes BMS-986416?

BMS-986416 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.

What phase is BMS-986416 in?

BMS-986416 is in Phase 1 clinical development. A Phase 1 trial has been completed, which evaluated the drug with and without nivolumab in patients with advanced solid tumors. As an investigational drug, it has not yet received regulatory approval and is still in the early stages of clinical testing.

What clinical trials is BMS-986416 in?

BMS-986416 has been studied in one clinical trial, registered as NCT04943900, titled "A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors." This Phase 1 trial enrolled 67 participants with advanced solid tumors and has been completed. The study was conducted in the United States, Argentina, Belgium, Canada, Chile, Japan, and the Netherlands.

Is BMS-986416 the same as nivolumab?

No, BMS-986416 is not the same as nivolumab. BMS-986416 is an investigational small molecule being studied for advanced solid tumors, while nivolumab is a separate, already-approved immunotherapy drug. In clinical trials, BMS-986416 has been tested both alone and in combination with nivolumab to evaluate their combined effects.