Trial Purpose

Keynote 365 is a phase 1B/2 study  to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). Currently enrolling cohorts are*:

Treatment emergent neuroendocrine carcinoma (t-NE)  cohorts

  • Cohort F pembrolizumab+lenvatinib
  • Cohort H pembrolizumab/vibostolimab coformulation,
  • Cohort I
    • Arm 1 pembrolizumab+carboplatin+etoposide
    • Arm 2 carboplatin+etoposide.

Entrance criteria for Cohorts F, H, I:

  • Prior next-generation hormonal agents (NHA) or prior docetaxel for metastatic hormone sensitive prostate cancer (mHSPC) or metastatic castrate resistant prostate cancer (mCRPC)
  • < 2 chemotherapies for mCRPC
  • < 2 second generation hormonal therapies for mCRPC

Additional criteria apply and only an HCP can determine if you are eligible.

Primary objectives :

  1. Safety and tolerability of pembrolizumab combination therapies to estimate the PSA response rate for each combination cohort
  2. Evaluate the Objective Response Rate (ORR) for each cohort based on RECIST 1.1 by Blinded Independent Review

 

* Enrollment status updated as of 5/31/23

View full trial information on Clinicaltrials.gov

NATIONAL TRIAL REFERENCE NUMBER

NCT02861573

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

Metastatic Castration-Resistant Prostate Cancer

Age Range Icon

Age Range

18+

Sex Icon

Sex

Male

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 November 17, 2016
  • Estimated primary completion date May 30, 2025
  • Estimated trial completion date May 30, 2025

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

Contact our Trial Information Center

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

NATIONAL TRIAL REFERENCE NUMBER

NCT02861573

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