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Hormone Therapy
BMS-986460 for Prostate Cancer
Phase 1
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate.
Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 212 weeks
Awards & highlights
Study Summary
This trial tests a new drug to treat advanced prostate cancer in men to see if it's safe and effective.
Who is the study for?
This trial is for men with advanced prostate cancer that has spread and doesn't respond to hormone therapy. They should be relatively healthy, able to perform daily activities (ECOG 0-1), and have a PSA level of at least 2 ng/mL. Men can't join if they have serious health issues, brain metastases, or significant heart disease.Check my eligibility
What is being tested?
The study is testing BMS-986460's safety and early effectiveness in treating metastatic castration-resistant prostate cancer. Participants will receive this investigational drug to see how well it works and what side effects it may cause.See study design
What are the potential side effects?
While the specific side effects of BMS-986460 are not listed here, common ones for cancer treatments include fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, liver function changes, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer has been confirmed by a lab test.
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My prostate cancer has worsened despite hormone therapy and at least one other treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 212 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 212 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of deaths
Number of participants with AEs leading to study intervention discontinuation
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
+2 moreSecondary outcome measures
Area under the plasma concentration-time curve (AUC)
Duration of response (DOR)
Maximum concentration (Cmax)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Administration of BMS-986460Experimental Treatment1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments often include androgen deprivation therapy (ADT), which reduces levels of male hormones that can promote cancer growth, and chemotherapy, which targets rapidly dividing cells. Immune checkpoint inhibitors, such as those targeting the PD-1/PD-L1 pathway, work by blocking proteins that prevent the immune system from attacking cancer cells.
This allows the immune system to recognize and destroy cancer cells more effectively. For prostate cancer patients, especially those with metastatic castration-resistant prostate cancer (CRPC), these treatments can be crucial as they offer a different mechanism to combat cancer cells that may not respond to traditional therapies.
The trial BMS-986460 is investigating such an immune checkpoint inhibitor, which could provide new hope for patients with advanced stages of the disease.
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,742 Total Patients Enrolled
43 Trials studying Prostate Cancer
5,568 Patients Enrolled for Prostate Cancer
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