Phase 3 Parkinson's Disease Trial, Completed NCT04191096 Sponsor: Merck Sharp & Dohme LLC Condition: Parkinson's Disease
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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 (NCT04191096) enrolled 1,251 people with prostate cancer — 626 in a group receiving pembrolizumab combined with enzalutamide and androgen deprivation therapy (ADT, a hormone-lowering treatment), and 625 in a group receiving a placebo combined with enzalutamide and ADT. The trial was designed to measure two main things: how long participants went without their cancer visibly growing or spreading on scans (called radiographic progression-free survival), and how long participants lived overall (overall survival). It also tracked several secondary measures, including how long before participants needed a new cancer treatment, how long before certain bone-related complications occurred, how long before a specific blood marker called PSA showed signs of rising, and how long before soft tissue tumours visibly grew on scans. The reported data shows that for every single outcome measured — both primary outcomes and all secondary outcomes — the submitted results list the values as "NA" (not available or not reported). This means that no numerical results for any of these measures were included in the data submitted to ClinicalTrials.gov. It is also noted that zero participants in either group were recorded as having "completed" the study, with all participants listed under "not completed," though the reasons for this were not provided in the submitted data. 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

NCT04191096
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:

  • You are a male with prostate cancer (specifically adenocarcinoma) that has been confirmed by a lab test, and it is not the small cell type.
  • Your cancer has spread to other parts of the body, shown by either 2 or more spots on a bone scan or spread to internal organs seen on a CT or MRI scan.
  • You are willing to continue hormone-suppressing therapy (to lower testosterone) throughout the study, or you have already had both testicles surgically removed.
  • You are generally well enough to carry out light activity and care for yourself (a standard doctor's fitness rating of 0 or 1, checked within 10 days of joining).
  • If you are already taking bone-strengthening medication, you have been on a stable dose before joining the trial.
  • Your kidneys, liver, and other organs are working well enough as shown by recent blood tests.
  • You are able to provide a recent tissue sample (biopsy taken within the last 12 months) from a tumor area that has not been previously treated with radiation (or a bone biopsy if your cancer is mainly in the bones).
  • You agree not to donate sperm and to either avoid sexual intercourse or use contraception for the entire treatment period and for at least 120 days after your last dose.
  • You agree to use a condom during any sexual activity where ejaculate could be passed to another person.

Who may not be able to join:

  • You have another cancer that is still growing or has needed active treatment in the past 3 years.
  • You have an autoimmune disease (where the immune system attacks the body) that needed medical treatment in the past 2 years.
  • You have been diagnosed with an immune system deficiency, or you are currently taking long-term steroid medication.
  • You had major surgery or a procedure on your prostate (not including a biopsy) within the past 28 days and have not fully recovered.
  • You have a digestive condition that affects how your body absorbs medication, or you are unable to swallow tablets or capsules.
  • You currently have an active infection, including tuberculosis, that requires treatment.
  • You have a history of lung inflammation (not caused by infection) that needed steroid treatment, or you currently have lung inflammation.
  • You have an active HIV, hepatitis B, or hepatitis C infection.
  • Your cancer has spread to your brain or the lining around it.
  • You have a history of seizures or a condition that makes seizures more likely.
  • You lost consciousness at any point in the 12 months before screening.
  • You have had a heart attack or uncontrolled chest pain in the past 6 months, or you have moderate-to-severe heart failure.
  • Your blood pressure is too low (below 86 systolic) or uncontrolled and too high (above 170 systolic or 85 diastolic) at your screening visit.
  • You have a history of serious irregular heartbeats.
  • You have had an allergic reaction to either of the study drugs (pembrolizumab or enzalutamide) or their ingredients.
  • You previously received hormone-suppressing therapy for more than 39 months for non-spreading prostate cancer, or received it within the past 9 months, or your cancer got worse while on that therapy.
  • You have previously been treated with newer hormone-blocking drugs such as abiraterone, enzalutamide, apalutamide, or darolutamide.
  • You have previously received certain types of immunotherapy drugs that work on the PD-1 or PD-L1 pathway, or similar immune-targeting treatments.
  • You received a live vaccine within 30 days before joining the trial.
  • Your bone scan shows an extremely widespread pattern throughout your bones (called a "superscan") (confirm with trial site).
  • You have received an organ or tissue transplant from another person.
  • You are planning to father children from the time of screening until 120 days after your last dose.
  • You have already received drug treatment, radiation, or surgery for your metastatic prostate cancer, with some limited exceptions (confirm with trial site for details on whether short-term hormone therapy, limited palliative radiation, or a short course of chemotherapy with docetaxel may still allow you to qualify).

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 27 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

Chris OBrien Lifehouse ( Site 0300), Camperdown, New South Wales
Port Macquarie Base Hospital ( Site 0301), Port Macquarie, New South Wales
Riverina Cancer Care Center ( Site 0302), Wagga Wagga, New South Wales
Gallipoli Medical Research Ltd ( Site 0309), Greenslopes, Queensland
John Flynn Hospital & Medical Centre ( Site 0308), Tugun, Queensland
Box Hill Hospital ( Site 0304), Box Hill, Victoria
Monash Health ( Site 0305), Clayton, Victoria
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0306), Melbourne, Victoria
Fiona Stanley Hospital ( Site 0311), 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
12 February 2020
Est. completion
31 October 2022

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇪 Peru 🇵🇱 Poland 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

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 (BICR); Overall Survival (OS)

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: 27 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