An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

December 13, 2023 updated by: Bristol-Myers Squibb

A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers

The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Local Institution - 0001
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Local Institution - 0003
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0005
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232-1305
        • Local Institution - 0006
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • 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:

  • Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
  • Must have experienced radiographically documented progressive disease on or after the most recent therapy
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

  • Primary central nervous system (CNS) malignancy
  • Other active malignancy requiring concurrent intervention
  • Uncontrolled or significant cardiovascular 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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • OPDIVO
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • YERVOY
Drug: BMS-986301
Specified dose on specified days
Experimental: Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • OPDIVO
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • YERVOY
Drug: BMS-986301
Specified dose on specified days
Experimental: Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • OPDIVO
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • YERVOY
Drug: BMS-986301
Specified dose on specified days
Experimental: Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • OPDIVO
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • YERVOY
Drug: BMS-986301
Specified dose on specified days
Experimental: Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • OPDIVO
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • YERVOY
Drug: BMS-986301
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose-limiting toxicity (DLTs)
Time Frame: Cycle 1 (28 days)
Cycle 1 (28 days)
Incidence of adverse events (AEs)
Time Frame: From Baseline until study exit (up to approximately 2 years)
From Baseline until study exit (up to approximately 2 years)
Incidence of serious adverse events (SAEs)
Time Frame: From Baseline until study exit (up to approximately 2 years)
From Baseline until study exit (up to approximately 2 years)
Incidence of AEs leading to discontinuation
Time Frame: From Baseline until study exit (up to approximately 2 years)
From Baseline until study exit (up to approximately 2 years)
Incidence of deaths
Time Frame: From Baseline until study exit (up to approximately 2 years)
From Baseline until study exit (up to approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame: From Baseline until disease progression (approximately 2 years)
From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame: From Baseline until disease progression (approximately 2 years)
From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame: From Baseline until disease progression (approximately 2 years)
From Baseline until disease progression (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.

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 26, 2019

Primary Completion (Estimated)

April 19, 2024

Study Completion (Estimated)

April 19, 2024

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA046-006
  • 2018-003610-41 (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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