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

CLINICALTRIALS.GOV IDENTIFIER:

NCT02861573

When speaking to your doctor, please have the trial identifier number available.

About The Trial

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Phase 1

Tests the medicine or vaccine in a small group of 20 to 100 volunteers who are usually healthy, but not always. The trial often takes place in a hospital.

Phase 2

Tests the medicine or vaccine in approximately 100 to 500 volunteers. In the case of medicines, volunteers usually have the disease or condition the investigational medicine is designed to treat. In vaccine studies, the volunteers are usually healthy.

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Dates

  • Actual study start date November 17, 2016
  • Estimated primary completion date May 30, 2025
  • Estimated study completion date May 30, 2025

Eligibility

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Conditions

Metastatic Castration-resistant Prostate Cancer

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Age Range

18 - No Age Maximum

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Sex

Male

Trial locations

What Can You Do Next?

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

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Discuss With Your Doctor

Print this page or email it to your doctor to discuss at your next visit.

CLINICALTRIALS.GOV IDENTIFIER:

NCT02861573

When speaking to your doctor, please have the trial identifier number available.

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.