Trial Purpose

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).

The goal of substudy 01A is to evaluate the safety and efficacy of MK-5684-based treatment combinations, or as a single agent, in participants with mCRPC.

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the MK-5684-based treatment combinations. There will be no hypothesis testing in this study.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER

NCT06353386

EU CT Number

2023-506288-33

When you talk with your doctor or clinical trial team member, please have the trial identifier number available.

Resources

Eligibility

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.

Conditions Icon

Conditions

Prostatic Neoplasms, Castration-Resistant

Age Range Icon

Age Range

18+

Sex Icon

Sex

All

About the trial

Trial phase Icon Current trial phase

Trial Phase 1

Investigational medication is tested for safety on a relatively small group of 20 to 100 volunteers who are usually healthy, but not always. Phase 1 trials may happen in a doctor’s office or a hospital.

Trial Phase 2

In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participants – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.

Trial start Icon Trial start and end dates
  • Trial start date May 20, 2024
  • Estimated primary completion date March 31, 2028
  • Estimated trial completion date March 31, 2028

Trial locations

Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.

What can you do next?

If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

CLINICALTRIALS.GOV IDENTIFIER

NCT06353386

EU CT Number

2023-506288-33

When you talk with your doctor or clinical trial team member, please have the trial identifier number available.

Taking part in a clinical trial is an important decision

If you are considering joining a clinical trial, first learn as much as you can about:

  • The investigational treatment that is being studied
  • What the risks and possible benefits are for participants

Talk to your doctor about the clinical trial before you decide to join.

Read our “What to Consider” page for more questions to ask and think about