Conditions
Metastatic Castration-Resistant Prostate Cancer
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 :
- Safety and tolerability of pembrolizumab combination therapies to estimate the PSA response rate for each combination cohort
- 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
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.
Age Range
18+
Sex
Male
About the trial
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 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.
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