A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

February 9, 2024 updated by: Bristol-Myers Squibb

A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

  • 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 the NCT# and Site #.

Study Locations

  • Belgium
    • Bruxelles-Capitale, Région De
      • Brussels, Bruxelles-Capitale, Région De, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
          • Rachel Galot, Site 0016
          • Phone Number: 3227641037
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Recruiting
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
        • Contact:
          • Antoine Italiano, Site 0003
          • Phone Number: 33556333333
    • Paris
      • Villejuif, Paris, France, 94800
        • Recruiting
        • Gustave Roussy
        • Contact:
          • Antoine Hollebecque, Site 0002
          • Phone Number: 33142114385
    • Provence-Alpes-Côte-d'Azur
      • Marseille, Provence-Alpes-Côte-d'Azur, France, 13273
        • Recruiting
        • Institut Paoli-Calmettes
        • Contact:
          • Cecile Vicier, Site 0004
          • Phone Number: 33491223670
    • Rhône-Alpes
      • Lyon CEDEX 08, Rhône-Alpes, France, 69373
        • Not yet recruiting
        • Centre Leon Berard
        • Contact:
          • Armelle Vinceneux, Site 0009
          • Phone Number: 33426556833
  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
        • Contact:
          • SALVATORE INTAGLIATA, Site 0026
          • Phone Number: 0352673687
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
        • Contact:
          • Gennaro Daniele, Site 0025
          • Phone Number: +39 06 3015 3446
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Humanitas
        • Contact:
          • Armando Santoro, Site 0023
          • Phone Number: 390282244080
    • Toscana
      • Siena, Toscana, Italy, 53100
        • Not yet recruiting
        • Local Institution - 0024
        • Contact:
          • Site 0024
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
        • Contact:
          • Gerrina Ruiter, Site 0030
          • Phone Number: 0031205122958
      • Groningen, Netherlands, 9714 CZ
        • Recruiting
        • University Medical Center Groningen
        • Contact:
          • T.Jeroen Hiltermann, Site 0018
          • Phone Number: (3150) 361-3532
  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
          • Victor Moreno Garcia, Site 0014
          • Phone Number: 615387743
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
        • Contact:
          • Emiliano Calvo Aller, Site 0011
          • Phone Number: +34620423957
    • Andalucía
      • Málaga, Andalucía, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Javier Garcia Corbacho, Site 0015
          • Phone Number: 951032250
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Badalona
        • Contact:
          • Cinta Hierro Carbo, Site 0013
          • Phone Number: 34934978925
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Ignacio Melero Bermejo, Site 0012
          • Phone Number: 34653574014
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute - West Los Angeles Office
        • Contact:
          • Justin Moyers, Site 0021
          • Phone Number: 310-231-2127
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital-Smilow Cancer Center
        • Contact:
          • Patricia Lo Russo, Site 0007
          • Phone Number: 203584-2144
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Contact:
          • Martin Gutierrez, Site 0010
          • Phone Number: 551-996-5863
      • Hackensack, New Jersey, United States, 07601
        • Withdrawn
        • Hackensack University Medical Center
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • R.J. Zuckerberg Cancer Center
        • Contact:
          • Richard Carvajal, Site 0022
          • Phone Number: 917-886-9377

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.

    • Part 1A may have a solid malignancy of any histology.
    • Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
    • Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).
  • Tumor biopsy must be obtained for all participants (unless medically precluded).

Exclusion Criteria:

  • History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD- 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
  • Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
  • Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.

Other protocol-defined criteria may 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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation: BMS-986449 monotherapy
Drug: BMS-986449
Specified dose on specified days
Experimental: Dose Escalation: BMS-986449 + nivolumab
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • OPDIVO®
Drug: BMS-986449
Specified dose on specified days
Experimental: Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts
Drug: BMS-986449
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Dose-Limiting Toxicities (DLTs)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of participants with Adverse Events (AEs)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of participants with Serious Adverse Events (SAEs)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of participants with AEs leading to discontinuation
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of deaths
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Time of maximum observed concentration within a dosing interval (Tmax)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Area under the concentration-time curve within a dosing interval (AUC[TAU])
Time Frame: Up to approximately 4 years
Up to approximately 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)

June 6, 2023

Primary Completion (Estimated)

May 21, 2025

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA120-1001
  • 2023-503484-42 (EudraCT Number)
  • U1111-1287-3575 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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