Keynote 365

For patients with metastatic castration-resistant prostate cancer (mCRPC)

Study of Pembrolizumab Combination Therapies in Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be three cohorts in this study with 70 participants enrolled in each cohort: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome measures will be assessed individually for each cohort.

Status:

Recruiting

Phase 1 Icon

Trial Phase

The investigational immunotherapy is being studied in a small group of patients for the first time to evaluate its safety, determine a safe dosage range and identify side effects.

Eligibility

About the Trial

All patients who enroll in the trial will receive medication while on the study.

  • 22% will receive pembrolizumab along with olaparib*
  • 39% will receive pembrolizumab, docetaxel along with prednisone*
  • 39% will receive pembrolizumab along with enzalutamide*

*Your doctor will decide which treatment is best for you based on your previous treatment(s) for your mCRPC.

Trial Purpose
5

US Trial Locations

Clinical trial sites are places such as hospitals or clinics where the trial is being conducted.

See Locations

National Trial Reference Number

NCT02861573 Read More at clinicaltrials.gov

What Can You Do Next?

If you would like to learn about this clinical trial or see if you can participate, you can:

Contact Our Trial Info Center

To learn more, call 1-888-577-8839

Discuss With Your Doctor

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Tip: To help with understanding of some clinical terms used on the page, select an underlined term to see what they mean.

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Condition

The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Metastatic Castration-Resistant Prostate Cancer

Age range

18 — no age maximum

Gender(s)

Male

Trial Purpose

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be three cohorts in this study with 70 participants enrolled in each cohort: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome measures will be assessed individually for each cohort.

Important information

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.

Trial Locations

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    Location
    Status
  • Irvine, California, United States, 92697
    Recruiting
  • Los Angeles, California, United States, 90095
    Recruiting
  • New Brunswick, New Jersey, United States, 08903-2681
    Recruiting
  • Seattle, Washington, United States, 98109
    Recruiting
  • San Francisco, California, United States, 94115
    Recruiting

How to Learn More

When speaking to your doctor, please have the trial reference number available. You can also call 1-888-577-8839 for more information.

Print or email this page.

Trial reference number

A unique identification code given to each clinical trial registered on clinicaltrials.gov.

Keynote number

A unique identification code used by the sponsor to identify a specific trial.
Keynote-365

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
keynote 365 trial logo

Call 1-888-577-8839 to contact our trial information center

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.