A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors

September 25, 2024 updated by: Bristol-Myers Squibb

A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors

The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • 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, C1280
        • Local Institution - 0028
      • Cordoba, Argentina, 5002
        • Local Institution - 0032
    • Rio Negro
      • Viedma, Rio Negro, Argentina, 8500
        • Local Institution - 0029
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Local Institution - 0023
  • Belgium
      • Brussels, Belgium, 1200
        • Local Institution - 0012
    • Brussel
      • Brussel (Jette), Brussel, Belgium, 1090
        • Local Institution - 0018
    • MA
      • Edegem, MA, Belgium, 2650
        • Local Institution - 0015
  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0031
  • Korea, Republic of
      • Seoul, Korea, Republic of, 3080
        • Local Institution - 0024
      • Seoul, Korea, Republic of, 3722
        • Local Institution - 0027
      • Seoul, Korea, Republic of, 6351
        • Local Institution - 0025
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Local Institution - 0026
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0017
      • Barcelona, Spain, 08908
        • Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
      • Barcelona, Spain, 08023
        • Local Institution - 0030
      • Madrid, Spain, 28027
        • Local Institution - 0014
      • Madrid, Spain, 28041
        • Local Institution - 0009
      • Madrid, Spain, 28050
        • Local Institution - 0016
      • Pamplona, Spain, 31008
        • Local Institution - 0033
    • Andaluca
      • Malaga, Andaluca, Spain, 29010
        • Local Institution - 0008
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Local Institution - 0021
    • California
      • La Jolla, California, United States, 92093
        • University California San Diego Moores Cancer Center
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
      • Los Angeles, California, United States, 90404
        • UCLA Health
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0001
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Carolina BioOncology Institute, PLLC
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research - Medical City Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Local Institution - 0006

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Parts 1A, 1B, 1C:

  • Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease

Part 1D:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.

All Parts:

  • Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Prior organ or tissue allograft
  • Leptomeningeal metastases
  • Untreated CNS metastases
  • Serious or uncontrolled medical disorders

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A: BMS-986406 (Monotherapy Dose Escalation)
Biological: BMS-986406
Specified dose on specified days
Experimental: Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986406
Specified dose on specified days
Experimental: Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986406
Specified dose on specified days
Experimental: Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986406
Specified dose on specified days
Experimental: Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Carboplatin
Specified dose on specified days
Drug: Paclitaxel
Specified dose on specified days
Drug: Pemetrexed
Specified dose on specified days
Biological: BMS-986406
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 100 days
Up to 100 days
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 100 days
Up to 100 days
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to 28 days
Up to 28 days
Number of participants with AEs leading to discontinuation
Time Frame: Up to 100 days
Up to 100 days
Number of participants with death
Time Frame: Up to 100 days
Up to 100 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease control rate (DCR)
Time Frame: Up to 24 months
Up to 24 months
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 14 days
Up to 14 days
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to 14 days
Up to 14 days
Trough observed plasma concentration (Ctrough)
Time Frame: Up to 14 days
Up to 14 days
Incidence of anti-drug antibody (ADAs)
Time Frame: Up to 14 days
Up to 14 days
Objective response rate (ORR)
Time Frame: Up to 24 months
Up to 24 months
Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma
Time Frame: Up to 24 months
Up to 24 months
DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer
Time Frame: Up to 24 months
Up to 24 months
DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types
Time Frame: Up to 24 months
Up to 24 months

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)

March 31, 2022

Primary Completion (Actual)

August 16, 2024

Study Completion (Actual)

August 16, 2024

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA111-001
  • 2021-006872-17 (EudraCT Number)
  • U1111-1270-3670 (Registry Identifier: WHO)

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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