RECRUITING

A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer

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Conditions

Metastatic Castration-resistant Prostate CancerProstate CancerCastration-resistant prostate cancerAdenocarcinoma of the prostateProstatic Neoplasms Castration-ResistantNeoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.

Official Title

A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer

Quick Facts

Study Start:2023-10-18
Study Completion:2031-07-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06067841

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate.
  2. * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  3. * Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL at Screening
  4. * Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
  1. * Participant must not have history of brain metastases.
  2. * Participant must not have impaired cardiac function or clinically significant cardiac disease.
  3. * Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Stanford Cancer Center
Palo Alto, California, 94304
United States
Florida Cancer Specialists Sarasota Drug Development Unit
Sarasota, Florida, 34232
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke Cancer Institute
Durham, North Carolina, 27710
United States
Local Institution - 0006
San Antonio, Texas, 78229
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

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 Registration Dates

Study Start Date2023-10-18
Study Completion Date2031-07-27

Study Record Updates

Study Start Date2023-10-18
Study Completion Date2031-07-27

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer
  • Castration-resistant prostate cancer
  • Adenocarcinoma of the prostate
  • Prostatic Neoplasms Castration-Resistant
  • Neoplasms

Additional Relevant MeSH Terms

  • Metastatic Castration-resistant Prostate Cancer