What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway, such as pembrolizumab and nivolumab, can cause a range of side effects. These include immune-related toxicities like pneumonitis, colitis, hepatitis, endocrinopathies (e.g., thyroid dysfunction), and skin reactions (e.g., rash, pruritus). Other side effects may include fatigue, diarrhea, and infusion-related reactions. It is important to monitor for these side effects and manage them promptly to ensure patient safety.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway. One notable approval is pembrolizumab, which has shown efficacy in various cancers, including prostate cancer. Additionally, lutetium Lu 177 vipivotide tetraxetan has been approved for PSMA-positive metastatic castration-resistant prostate cancer (CRPC) after prior treatment with androgen-receptor pathway inhibitors and taxane-based chemotherapy. These treatments aim to enhance the immune system's ability to fight cancer cells, similar to the investigational drug BMS-986460.

What other types of research exist?

Promising alternatives to BMS-986460 for prostate cancer patients include P-PSMA-101 CAR-T cells, which are being evaluated in a phase 1 trial for metastatic castration-resistant prostate cancer (mCRPC). Additionally, other immune checkpoint inhibitors like pembrolizumab and nivolumab, which have shown efficacy in various cancers, may also be considered based on their performance in clinical trials.

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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)

Must not have

Participant must not have history of brain metastases.

Participant must not have impaired cardiac function or clinically significant cardiac disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BMS-986460 to see if it is safe and effective for men with advanced prostate cancer that doesn't respond to hormone treatments. The goal is to find out if the drug can help control the cancer's growth and spread.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had cancer spread to my brain.

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My heart is healthy and I don't have significant heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of BMS-986460Experimental Treatment1 Intervention

0 / 5Eligibility criteria met

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.