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Purpose

This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC.

Condition

Eligibility

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

Inclusion Criteria

  • Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC. - For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy. - For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other). - Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion Criteria

  • Participants with Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form. - For Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors. - Participants who have hypoxia as defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen. - Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BMS-986506: Part 1A
  • Drug: BMS-986506
    Specified dose on specified days
Experimental
BMS-986506: Part 2A
  • Drug: BMS-986506
    Specified dose on specified days
Experimental
BMS-986506: Part 2B
  • Drug: BMS-986506
    Specified dose on specified days

Recruiting Locations

Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Stephanie Berg, Site 0006
617-632-4932

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Martin Voss, Site 0029
646-888-4721

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Elizabeth Plimack, Site 0002
215-728-3889

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
Benjamin Garmezy, Site 0026
713-444-7804

START San Antonio
San Antonio, Texas 78229
Contact:
Amita Patnaik, Site 0001
210-593-5250

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.