Phase 3 Parkinson's Disease Trial, Completed NCT03834493 Sponsor: Merck Sharp & Dohme LLC Condition: Parkinson's Disease
Back to Parkinsons Disease

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03834493) enrolled 1,244 people with prostate cancer — 621 in the group receiving pembrolizumab plus enzalutamide, and 623 in the group receiving a placebo plus enzalutamide. The trial was measuring two main things: how long participants lived overall (called "overall survival"), and how long it took before scans showed the cancer had visibly grown or spread (called "radiographic progression-free survival"). Several additional measures were also tracked, including PSA blood marker responses and tumour shrinkage rates. It is worth noting that no participants were recorded as having formally "completed" the study, meaning all had left the study before its scheduled end — for reasons such as death, stopping treatment, or other causes. The reported data shows that, for overall survival, participants in the pembrolizumab plus enzalutamide group had a median (middle value) of 24.7 months, compared with 27.3 months in the placebo plus enzalutamide group. For the time before scans showed cancer progression, the reported median was 10.4 months in the pembrolizumab group versus 9.0 months in the placebo group. The reported data also shows that the time until participants started a new cancer treatment was 13.2 months versus 12.6 months respectively. For PSA levels dropping by at least half (a commonly watched marker in prostate cancer), 49.0% of the pembrolizumab group and 45.1% of the placebo group met this measure. PSA falling to very low levels (below 0.2 ng/mL) was reported in 13.1% versus 12.6% of participants. Tumour shrinkage on scans was reported in 12.2% of the pembrolizumab group and 9.3% of the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Parkinson's Disease Trial, Completed

NCT03834493
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with a specific type of prostate cancer (adenocarcinoma, not small cell type), confirmed by a tissue or cell sample test.
  • People whose prostate cancer has continued to grow or spread while receiving hormone-suppressing treatment (or after having both testicles surgically removed), within the 6 months before joining the trial.
  • People who have evidence that their cancer has spread to bones or other parts of the body, confirmed by a bone scan, CT scan, or MRI.
  • People who either have never taken the drug abiraterone acetate, took it for at least 4 weeks without their cancer progressing, or took it for at least 8 weeks (or 14 weeks if cancer spread to bones) and then their cancer progressed.
  • People whose testosterone levels are being kept very low (below 50 ng/dL) through ongoing hormone-suppressing treatment.
  • People taking bone-protecting medications (such as bisphosphonates or denosumab) who have been on a stable dose before joining the trial.
  • People who agree to avoid donating sperm and to either abstain from sexual activity or use a condom, during treatment and for at least 90 days after the last dose of the study drug enzalutamide.
  • People who can provide a recent tissue biopsy (taken within 12 months of screening) from a soft tissue area that has not been previously treated with radiation, or a bone biopsy if the cancer is mainly in the bones.
  • People who are in good general health, able to carry out normal daily activities with little or no limitation (confirmed by a standard health assessment called ECOG score of 0 or 1), assessed within 7 days of joining the trial.

Who may not be able to join:

  • People who have another cancer that is still growing or has needed active treatment in the last 3 years.
  • People who have an active autoimmune disease (where the immune system attacks the body) that has needed systemic (whole-body) treatment in the past 2 years.
  • People who have an immune system deficiency condition, or who are currently taking long-term steroid medication throughout their body.
  • People who have had major surgery, including procedures on the prostate (other than a biopsy), within 28 days before joining the trial and have not fully recovered.
  • People who have a digestive condition that affects how their body absorbs medications, or who are unable to swallow tablets or capsules.
  • People who have an active infection (including tuberculosis) currently requiring treatment.
  • People who have a history of, or currently have, a non-infectious lung condition (such as pneumonitis or interstitial lung disease) that needed steroid treatment.
  • People who have an active HIV infection, active hepatitis B, or known active hepatitis C infection.
  • People who have active cancer spread to the brain or the lining of the brain or spinal cord.
  • People who have a known allergy or sensitivity to the study drugs pembrolizumab or enzalutamide, or to any of their ingredients.
  • People who have a history of seizures or any medical condition that may increase the risk of seizures.
  • People who have lost consciousness at any point in the 12 months before screening.
  • People who have very low or uncontrolled high blood pressure at their screening visit (confirm with trial site for exact values).
  • People who have a very slow heart rate (fewer than 50 beats per minute) found on a heart tracing (ECG) at screening.
  • People whose prostate cancer previously progressed while taking the drug ketoconazole.
  • People who have previously been treated with enzalutamide, apalutamide, darolutamide, or certain hormone-blocking drugs other than abiraterone acetate.
  • People who have previously received certain types of immunotherapy drugs that work on immune checkpoint pathways (such as anti-PD-1 or anti-PD-L1 treatments).
  • People who have previously been treated with radium or other radioactive treatments for prostate cancer.
  • People who have previously received chemotherapy such as docetaxel for advanced prostate cancer that no longer responds to hormone treatment.
  • People who have previously received certain anti-cancer antibody treatments (monoclonal antibodies) before joining the trial.
  • People who have recently used herbal products known to have anti-prostate cancer effects or to lower PSA levels (for example, saw palmetto) before joining the trial.
  • People who have received a live or weakened live vaccine within 30 days before joining the trial.
  • People who are currently taking part in, or have recently taken part in, another clinical trial involving an experimental treatment or device within the 4 weeks before the first study dose.
  • People whose bone scan shows a particular pattern called a "superscan" (confirm with trial site).
  • People who are planning to father children from the time of screening through to 90 days after the last dose of enzalutamide.
  • People who have received an organ or tissue transplant from another person.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Merck Sharp & Dohme LLC

Australian sites

St. Vincent's Hospital ( Site 0158), Darlinghurst, New South Wales
St George Hospital ( Site 0157), Kogarah, New South Wales
Macquarie University ( Site 0151), Macquarie University, New South Wales
Port Macquarie Base Hospital ( Site 0153), Port Macquarie, New South Wales
Calvary Mater Newcastle ( Site 0148), Waratah, New South Wales
Gallipoli Medical Research Ltd ( Site 0149), Greenslopes, Queensland
Gold Coast University Hospital ( Site 0150), Southport, Queensland
Royal Adelaide Hospital ( Site 0154), Adelaide, South Australia
Monash Medical Centre ( Site 0147), Clayton, Victoria
Fiona Stanley Hospital ( Site 0162), Perth, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
28 July 2019
Est. completion
12 December 2022

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇴 Colombia 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland Puerto Rico 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

10 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Overall Survival (OS); Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov