Phase 3 Parkinson's Disease Trial, Active, Not Recruiting NCT05116189 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 (NCT05116189) enrolled 643 people in total — 322 in the group receiving pembrolizumab combined with paclitaxel (with or without bevacizumab), and 321 in the group receiving a placebo combined with paclitaxel (with or without bevacizumab). The trial was measuring how long participants went without their disease getting worse — a timeframe researchers call "progression-free survival" — comparing the two groups. This was looked at both across all participants and within a smaller subgroup whose tumours had a particular biological marker (called PD-L1 positive, with a score of 1 or higher). The reported data shows the following numbers for how long, on average, participants went before their disease progressed or they passed away. Among all participants, the pembrolizumab group recorded 8.3 months and the placebo group recorded 6.4 months. Within the PD-L1 positive subgroup, the pembrolizumab group recorded 8.3 months compared with 7.2 months in the placebo group. A separate review carried out by an independent team (who did not know which group participants were in) reported similar figures: 8.4 months versus 6.4 months across all participants, and 8.5 months versus 7.6 months in the PD-L1 positive subgroup. The reported data for two other secondary outcomes — overall survival (how long participants lived in total) and the number of people who experienced side effects — were not provided in the submitted results. 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, Active, Not Recruiting

NCT05116189
Active, Not Recruiting 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 confirmed by lab testing to have epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  • People who have received 1 or 2 previous treatment regimens for ovarian cancer, including at least one treatment that contained platinum-based chemotherapy.
  • People whose cancer has shown signs of growing or spreading on a scan within 6 months (180 days) after their last platinum-based chemotherapy — this is sometimes called platinum-resistant disease.
  • People who are medically suitable to receive paclitaxel chemotherapy (and bevacizumab, if that treatment is being used).
  • People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale, assessed within 3 days before joining the trial (confirm with trial site).
  • People who are not pregnant and not breastfeeding, and who either cannot become pregnant or are using a highly effective form of contraception (with a failure rate of less than 1% per year).
  • People who have measurable or detectable disease visible on a scan, assessed by the local trial team.
  • People who have provided a tumour tissue sample — either from stored tissue or a new biopsy from a site that has not previously been treated with radiation.
  • People whose organs (such as kidneys, liver, and bone marrow) are functioning at an adequate level (confirm with trial site).
  • People who have given written informed consent to take part in the study.

Who may not be able to join:

  • People whose cancer is a non-epithelial type, or is classified as borderline, mucinous, seromucinous (predominantly mucinous), malignant Brenner's tumour, or undifferentiated carcinoma.
  • People whose cancer grew or spread during, or within 28 days of finishing, their very first platinum-based chemotherapy — known as primary platinum-refractory disease.
  • People whose cancer previously got worse while they were being treated with weekly paclitaxel on its own.
  • People who have had more than 2 previous treatment regimens for ovarian cancer.
  • People who received any systemic cancer treatment, investigational therapy, or maintenance therapy (including bevacizumab maintenance) within 4 weeks before joining the trial.
  • People who received radiation therapy within 2 weeks before starting the trial treatment.
  • People who have not fully recovered from surgery or surgical complications.
  • People who received certain blood cell-stimulating medications (such as G-CSF or GM-CSF) within 4 weeks before joining the trial.
  • People who received a live or live-attenuated vaccine within 30 days before the first dose of trial treatment.
  • People who have received an experimental drug or used an experimental medical device within 4 weeks before starting the trial.
  • People who have a diagnosed immune system deficiency or who are currently taking long-term steroid medication.
  • People who have another cancer that is currently active or has required treatment within the past 3 years.
  • People who have active cancer spread to the brain or the lining around the brain or spinal cord.
  • People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab, paclitaxel, bevacizumab, or any of their ingredients.
  • People who have an active autoimmune disease that has needed systemic medical treatment within the past 2 years.
  • People who have a history of, or currently have, non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment.
  • People who have an active infection currently requiring systemic treatment.
  • People with a known history of HIV infection.
  • People with a known history of Hepatitis B, or a currently active Hepatitis C infection.
  • People with a medical condition, ongoing therapy, or other circumstance that could affect the reliability of the trial results (confirm with trial site).
  • People with a known psychiatric condition or substance use disorder that could affect their ability to take part in the trial.
  • People who, in the trial doctor's judgement, are unlikely to be able to follow the trial's procedures and requirements.
  • People who have previously received a transplant of donor tissue or a solid organ.
  • (For people being considered for bevacizumab specifically) People with uncontrolled high blood pressure.
  • (For people being considered for bevacizumab specifically) People with a bowel blockage, abdominal fistula, gastrointestinal perforation, abdominal abscess, or evidence of cancer involving the lower bowel area on examination.
  • (For people being considered for bevacizumab specifically) People with a history of blood clotting disorders, significant bleeding, coughing up blood, or active gastrointestinal bleeding within 6 months before joining the trial.

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

Westmead Hospital-Department of Gynaecological Oncology ( Site 0201), Westmead, New South Wales
Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202), Brisbane, Queensland
Epworth Freemasons ( Site 0204), Melbourne, Victoria
St. John of God Subiaco Hospital ( Site 0203), Subiaco, 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
Active, Not Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
13 December 2021
Est. completion
5 March 2025

Where this trial is recruiting

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

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

Primary endpoints

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1); PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants

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