An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

December 29, 2025 updated by: Bristol-Myers Squibb

A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
219

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1431
        • Local Institution - 0017
      • Buenos Aires, Argentina, C1280AEB
        • Local Institution - 0016
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1426
        • Local Institution - 0011
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1096AAS
        • Local Institution - 0074
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5000HXL
        • Local Institution - 0014
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Local Institution - 0013
    • Distrito Federal
      • ABB, Distrito Federal, Argentina, C1199
        • Local Institution - 0008
      • CABA, Distrito Federal, Argentina, C1430
        • Local Institution - 0012
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0006
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 0046
      • Montreal, Quebec, Canada, H2X 0A9
        • Local Institution - 0042
  • Chile
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2520598
        • Local Institution - 0010
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Local Institution - 0036
      • Santiago, Santiago Metropolitan, Chile, 7510032
        • Local Institution - 0019
      • Santiago, Santiago Metropolitan, Chile, 7620002
        • Local Institution - 0035
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0009
  • France
      • Bron, France, 69677
        • Local Institution - 0018
      • Marseille, France, 13915
        • Local Institution - 0026
      • Paris, France, 75248
        • Local Institution - 0015
      • Toulon, France, 83100
        • Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
    • Gironde
      • Bordeaux, Gironde, France, 33075
        • Local Institution - 0034
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, France, 44800
        • Local Institution - 0022
  • Italy
      • Ancona, Italy, 60126
        • Local Institution - 0028
      • Catanzaro, Italy, 88100
        • Local Institution - 0033
      • Milan, Italy, 20162
        • Local Institution - 0031
      • Roma, Italy, 00168
        • Local Institution - 0039
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Local Institution - 0040
    • Veneto
      • Padua, Veneto, Italy, 35128
        • Local Institution - 0038
  • Spain
      • Madrid, Spain, 28041
        • Local Institution - 0023
      • Majadahonda, Spain, 28222
        • Local Institution - 0024
      • Seville, Spain, 41013
        • Local Institution - 0055
      • Valencia, Spain, 46026
        • Local Institution - 0025
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Local Institution - 0056
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Local Institution - 0054
  • United States
    • California
      • Costa Mesa, California, United States, 92627
        • Local Institution - 0075
      • Orange, California, United States, 92868-3201
        • Local Institution - 0050
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0005
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0002
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0004
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies

Exclusion Criteria:

  • Active, known or suspected autoimmune disease
  • Active malignancy requiring concurrent intervention
  • Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: BMS-986288 Monotherapy
Drug: BMS-986288
Specified dose on specified days
Experimental: Arm B: BMS-986288 in combination with Nivolumab
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986288
Specified dose on specified days
Experimental: Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib
Drug: Regorafenib
Specified dose on specified days
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986288
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Related Events for Cohorts 1A, 1B and 2B.
Time Frame: approximately 6 months
Safety releated events for Cohorts 1A, 1B and 2B.
approximately 6 months
Dose Limiting Toxicities Cohorts 1A, 1B and 2B.
Time Frame: 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.
approximately 5 weeks
Objective Response Rate by BICR in Cohort 2C
Time Frame: approximately 2.15 Months
The percentage of all treated participants whose BOR is either CR or PR by BICR per RECIST v1.1.
approximately 2.15 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate in Cohorts 1A, 1B and 2B
Time Frame: approximately 2.15 Months
The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.
approximately 2.15 Months
Duration of Response in Cohorts 1A, 1B and 2B
Time Frame: approximately 2.15 Months
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.
approximately 2.15 Months
Time to Response in Cohorts 1A, 1B and 2B
Time Frame: approximately 2.15 Months
Time to response (TTR) assessed by investigator is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.
approximately 2.15 Months
Progression Free Survival in Cohorts 1A, 1B and 2B
Time Frame: approximately 2.15 Months
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.
approximately 2.15 Months
Duration of Response by BICR in Cohort 2C
Time Frame: approximately 2.5 Months
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first.
approximately 2.5 Months
PFS by BICR in Cohort 2C
Time Frame: approximately 2.5 Months
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.
approximately 2.5 Months
Overall Survival in Cohort 2C
Time Frame: approximately 2.5 Months
OS is defined as the time from randomization to the time of death due to any cause.
approximately 2.5 Months
Objective Response Rate by Investigator in Cohort 2C
Time Frame: approximately 2.5 Months
The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.
approximately 2.5 Months
Duration of Response by Investigator in Cohort 2C
Time Frame: approximately 2.5 Months
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.
approximately 2.5 Months
PFS by Investigator in Cohort 2C
Time Frame: approximately 2.5 Months
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.
approximately 2.5 Months
Safety Related Events in Cohort 2C
Time Frame: approximately 6 Months
Safety Related Events in Cohort 2C
approximately 6 Months
Dose Limiting Toxicities in Cohort 2C
Time Frame: 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.
approximately 5 weeks
Cmax for Cohorts 1A, 1B and 2B
Time Frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Cmax is defined as maximum plasma concentration of the drug.
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Tmax for Cohorts 1A, 1B and 2B
Time Frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Tmax is defined is the time to maximum plasma concentration
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
AUC(0-T) for Cohorts 1A, 1B and 2B
Time Frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration.
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
AUC(Tau) for Cohorts 1A, 1B and 2B
Time Frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Area under the plasma concentration time-curve. AUC over the dosing interval.
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
C(Tau) for Cohorts 1A, 1B and 2B
Time Frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Ctau is defined as the concentration of study drug at the end of the dosing interval
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA043-001
  • 2021-004284-27 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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