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

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: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: Regorafenib; Drug: Nivolumab; Drug: BMS-986288

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Phase 2; Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Safety Related Events for Cohorts 1A, 1B and 2B.	Safety releated events for Cohorts 1A, 1B and 2B.	approximately 6 months
Dose Limiting Toxicities Cohorts 1A, 1B and 2B.	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	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

Outcome Measure	Measure Description	Time Frame
Objective Response Rate in Cohorts 1A, 1B and 2B	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	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 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	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	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	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	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	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	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	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	Safety Related Events in Cohort 2C	approximately 6 Months
Dose Limiting Toxicities in Cohort 2C	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	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	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	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	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	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

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2019
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; regorafenib
• Other Study ID 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