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BMS-986288

Phase 1

Advanced Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 20, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment219

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986288 · 1 trial · 1 indication

Phase 1 1
NCT03994601An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid CancersAdvanced Cancer
COMPLETED219 Analytics
PHASE1COMPLETED
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety Related Events for Cohorts 1A, 1B and 2B.
approximately 6 months

Safety releated events for Cohorts 1A, 1B and 2B.

Dose Limiting Toxicities Cohorts 1A, 1B and 2B.
approximately 5 weeks

A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.

Objective Response Rate by BICR in Cohort 2C
approximately 2.15 Months

The percentage of all treated participants whose BOR is either CR or PR by BICR per RECIST v1.1.

Secondary Endpoints

Objective Response Rate in Cohorts 1A, 1B and 2B
approximately 2.15 Months
Duration of Response in Cohorts 1A, 1B and 2B
approximately 2.15 Months
Time to Response in Cohorts 1A, 1B and 2B
approximately 2.15 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A: BMS-986288 MonotherapyEXPERIMENTAL -
Arm B: BMS-986288 in combination with NivolumabEXPERIMENTAL -
Part 2C: BMS-986288 in combination with Nivolumab and RegorafenibEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986288DRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
RegorafenibDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Received, and t...

Countries:United StatesArgentinaCanadaChileFranceItalySpain
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about BMS-986288

What is BMS-986288 used for?

BMS-986288 is an investigational small molecule being studied for the treatment of advanced cancer. It is being evaluated in patients with advanced solid cancers, including in combination with another immunotherapy drug. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes BMS-986288?

BMS-986288 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced cancer.

What phase is BMS-986288 in?

BMS-986288 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The Phase 1 trial has been completed, and the drug is being studied for the treatment of advanced cancer.

What clinical trials is BMS-986288 in?

BMS-986288 has been studied in a Phase 1 clinical trial with the identifier NCT03994601. This trial evaluated BMS-986288 alone and in combination with nivolumab in patients with advanced solid cancers. The trial was completed and enrolled 219 participants across multiple countries.

Is BMS-986288 the same as nivolumab?

No, BMS-986288 is not the same as nivolumab. BMS-986288 is an investigational small molecule being studied for advanced cancer, while nivolumab is a separate immunotherapy drug. In the clinical trial NCT03994601, BMS-986288 was studied both alone and in combination with nivolumab.