A Phase I/II Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors

Study Identifier:
CA236-0001
CT.gov Identifier:
NCT06697197
EudraCT Identifier:
2024-516602-28
EU Trial (CTIS) Number:
2024-516602-28-00
Study Contact Information:
N/A
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1A
    • Read More
  • Drug: Intervention/Treatment:
  • Drug: Experimental: Part 1B1
  • Drug: Drug: Nivolumab and rHuPH20
  • Drug: Experimental: Part 1B2
  • Drug: Drug: Nivolumab/relatlimab/rHuPH20
  • Drug: Experimental: Part 1B3
  • Drug: Drug: Bevacizumab
  • Drug: Experimental: Part 1C
  • Drug: Experimental: Part 2A
  • Drug: Experimental: Part 2B1
  • Drug: Experimental: Part 2B2
  • Drug: Experimental: Part 2B3
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
    • Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
    Exclusion criteria
    • History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
    • Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
    • Other protocol-defined Inclusion/Exclusion criteria apply.

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor