A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

October 3, 2023 updated by: Bristol-Myers Squibb

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

425

Phase

  • 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 Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Local Institution - 0037
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, 1121
        • Local Institution - 0038
      • Caba, Distrito Federal, Argentina, C1430
        • Local Institution - 0052
  • Australia
    • New South Wales
      • North Sydney, New South Wales, Australia, 2060
        • Local Institution - 0015
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0014
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Local Institution
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0047
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0026
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile, 8420383
        • Local Institution - 0036
  • Finland
      • Helsinki, Finland, 00029
        • Local Institution - 0039
  • Germany
      • Essen, Germany, 45147
        • Local Institution - 0030
      • Hamburg, Germany, 20251
        • Local Institution - 0035
      • Heidelberg, Germany, 69120
        • Local Institution - 0031
  • Italy
      • Milan, Italy, 20133
        • Local Institution - 0048
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione Pascale
      • Siena, Italy, 53100
        • A.O.U.Senese - Policl.S.Maria alle Scotte
  • Poland
      • Warszawa, Poland, 02-781
        • Local Institution - 0040
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0045
      • Craiova, Romania, 200542
        • Local Institution - 0041
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0044
      • Madrid, Spain, 28040
        • Local Institution - 0023
      • Madrid, Spain, 28041
        • Local Institution - 0050
      • Malaga, Spain, 29010
        • Local Institution - 0043
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Local Institution - 0042
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28027
        • Local Institution - 0022
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0005
      • Denver, Colorado, United States, 80218
        • Local Institution - 0006
    • Florida
      • Miami, Florida, United States, 33176
        • Local Institution - 0017
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0024
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0001
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0003
      • New York, New York, United States, 10032
        • Local Institution - 0002
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Local Institution - 0029
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Local Institution - 0013
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0004
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Local Institution - 0008
    • Texas
      • Austin, Texas, United States, 78705
        • Local Institution - 0010
      • Dallas, Texas, United States, 75246
        • Local Institution - 0009
      • Houston, Texas, United States, 77030
        • Local Institution - 0021
      • San Antonio, Texas, United States, 78240
        • Local Institution - 0016
      • Tyler, Texas, United States, 75702
        • Local Institution - 0011
    • Virginia
      • Leesburg, Virginia, United States, 20176
        • Local Institution - 0012
      • Norfolk, Virginia, United States, 23502
        • Local Institution - 0007
    • Washington
      • Vancouver, Washington, United States, 98684
        • Local Institution - 0018

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
  • Willing and able to comply with all study procedures

Exclusion Criteria:

  • Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
  • Other active malignancy requiring concurrent intervention
  • Prior organ allograft
  • Active, known, or suspected autoimmune disease

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
Intervention / Treatment
Experimental: Part 1A: BMS-986249
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 1B: BMS-986249 + nivolumab (nivo)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2A Arm C: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2A Arm D: ipilimumab + nivo then nivo
Previously untreated unresectable stage III-IV melanoma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Part 2A Arm F: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2B Cohort 1: BMS-986249 + nivo
Advanced or intermediate hepatocellular carcinoma (HCC)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2B Cohort 2: BMS-986249 + nivo
Metastatic castration-resistant prostate cancer (CRPC)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2B Cohort 3: BMS-986249 + nivo
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2A Arm B: BMS-986249 + nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2A Arm E: Nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of AEs leading to discontinuation
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of death
Time Frame: Up to 4 years
Up to 4 years
Number of participants with laboratory abnormalities
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of treatment-related Grade 3-5 AEs
Time Frame: Within 24 weeks
Within 24 weeks
Objective Response Rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Up to 2.5 years
Up to 2.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax (Maximum observed serum concentration)
Time Frame: Up to 2 years
Up to 2 years
Tmax (Time of maximum observed concentration)
Time Frame: Up to 2 years
Up to 2 years
AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration)
Time Frame: Up to 2 years
Up to 2 years
ORR as assessed by investigator using RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer)
Time Frame: Up to 4 years
Up to 4 years
Duration of response (DOR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)
Time Frame: Up to 4 years
Up to 4 years
Progression-Free survival (PFS) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)
Time Frame: Up to 4 years
Up to 4 years
Time to response (TTR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)
Time Frame: Up to 4 years
Up to 4 years
Incidence of AEs in Part 2 of Study
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of SAEs in Part 2 of Study
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of AEs leading to discontinuation in Part 2 of study
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of death in Part 2 of study
Time Frame: Up to 4 years
Up to 4 years
Number of participants with clinical laboratory abnormalities Part 2 of study
Time Frame: Up to 2.5 years
Up to 2.5 years
Time to Deterioration (TTD) in Part 2 of study
Time Frame: Up to 4 Years
Up to 4 Years

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • 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)

December 6, 2017

Primary Completion (Estimated)

September 19, 2024

Study Completion (Estimated)

September 19, 2024

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 8, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA030-001
  • 2018-000416-21 (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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