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 I
    • Arm 1 pembrolizumab+carboplatin+etoposide
    • Arm 2 carboplatin+etoposide.

Entrance criteria for Cohort I:

  • Prior androgen deprivation therapy (ADT) for metastatic prostate cancer
  • < 2 chemotherapies for mCRPC
  • < 2 second generation hormonal therapies for mCRPC
  • No prior treatment for prostate cancer with platinum-containing drugs

Adenocarcinoma cohort:

  • Cohort J
    • Arm J1 belzutifan
    • Arm J2 pembrolizumab + belzutifan (Arm J2 is not currently enrolling)

Entrance criteria for Cohort J:

  • Prior docetaxel for metastatic castrate resistant prostate cancer (mCRPC)
  • 1 other chemotherapy for mCRPC
  • 2 second generation hormonal therapies

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 18Sep2023

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 October 22, 2027
  • Estimated study completion date October 22, 2027

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.