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Purpose

The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification). - Participants must, for Arm D, have a PD-L1 expression (≥50%). - Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.

Exclusion Criteria

  • Participants must not have untreated central nervous system (CNS) metastases. - Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment. - Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted. - Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
  • Drug: BMS-986523
    Specified dose on specified days
Experimental
Arm B
  • Drug: BMS-986523
    Specified dose on specified days
Experimental
Arm C
  • Drug: BMS-986523
    Specified dose on specified days
Experimental
Arm D
  • Drug: BMS-986523
    Specified dose on specified days
  • Drug: Pembrolizumab
    Specified dose on specified days
Experimental
Arm E
  • Drug: BMS-986523
    Specified dose on specified days
  • Drug: Cetuximab
    Specified dose on specified days
Experimental
Arm F
  • Drug: BMS-986523
    Specified dose on specified days
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Nab-Paclitaxel
    Specified dose on specified days

Recruiting Locations

Johns Hopkins Hospital
Baltimore, Maryland 21287
Contact:
Nilofer Azad, Site 0009
410-502-2995

NEXT Oncology
San Antonio, Texas 78229
Contact:
David Sommerhalder, Site 0001
210-580-9500

START Mountain Region
West Valley City, Utah 84119
Contact:
Justin Call, Site 0007
801-907-4750

NEXT Virginia
Fairfax, Virginia 22031
Contact:
Alexander Spira, Site 0011
703-280-5390

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.