An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

April 2, 2024 updated by: Bristol-Myers Squibb

A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

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

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0013
    • Victoria
      • Melbourne, Victoria, Australia, 3084
        • Local Institution - 0015
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6X 1E8
        • Local Institution - 0014
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution - 0019
  • Japan
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 6500017
        • Local Institution - 0009
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0008
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Local Institution - 0004
      • Los Angeles, California, United States, 90033
        • Local Institution - 0006
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0007
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5912
        • Local Institution - 0018
      • Grand Rapids, Michigan, United States, 49546
        • Local Institution - 0010
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Local Institution - 0012
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Local Institution - 0016
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0005
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Local Institution - 0002

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:

  • Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1)
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Participants 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 solid tumor histologies
  • Women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Active, known or suspected autoimmune disease
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
  • Other active malignancy requiring concurrent intervention

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 A Dose Escalation: BMS-986258
Biological: BMS-986258
Specified dose on specified days
Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
Biological: BMS-986258
Specified dose on specified days
Drug: rHuPH20
Specified dose on specified days
Other Names:
  • Enhanze
Experimental: Part B Dose Escalation: BMS-986258 + nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986258
Specified dose on specified days
Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986258
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria
Time Frame: Approximately 2 years
Approximately 2 years
Incidence of adverse events (AEs)
Time Frame: Approximately 2 years
Approximately 2 years
Incidence of serious adverse events (SAEs)
Time Frame: Approximately 2 years
Approximately 2 years
Incidence of AEs leading to discontinuation
Time Frame: Approximately 2 years
Approximately 2 years
Incidence of AEs leading to death
Time Frame: Approximately 2 years
Approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time Frame: Approximately 2 years
Approximately 2 years
Objective response rate (ORR)
Time Frame: Up to 12 months
Up to 12 months
Median duration of response (mDOR)
Time Frame: Up to 12 months
Up to 12 months
Progression free survival (PFS) rate
Time Frame: Up to 12 months
Up to 12 months
Maximum observed serum concentration (Cmax)
Time Frame: Approximately 2 years
Approximately 2 years
Time of maximum observed concentration (Tmax)
Time Frame: Approximately 2 years
Approximately 2 years
Observed concentration at the end of a dosing interval (Ctau)
Time Frame: Approximately 2 years
Approximately 2 years
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Time Frame: Approximately 2 years
Approximately 2 years
Trough observed serum concentration at the end of the dosing interval (Ctrough)
Time Frame: Approximately 2 years
Approximately 2 years
Concentration at the end of infusion (Ceoi)
Time Frame: Approximately 2 years
Approximately 2 years
Incidence of anti-drug antibody (ADA) to BMS-986258
Time Frame: Approximately 2 years
Approximately 2 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.

General Publications

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 8, 2018

Primary Completion (Estimated)

December 28, 2024

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

February 21, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA031-002
  • 2019-000442-35 (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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