Phase 2 Prostate Cancer Trial, Recruiting NCT06863272 Sponsor: Merck Sharp & Dohme LLC Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06863272
Recruiting Phase 2 🇦🇺 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 type of prostate cancer called adenocarcinoma, confirmed by a tissue or cell sample, that is not the small cell type.
  • People whose prostate cancer continued to grow or spread while they were on hormone-reducing therapy (or after surgical removal of both testicles), within 6 months before the screening visit.
  • People who currently have evidence that their cancer has spread to other parts of the body (metastatic disease).
  • People who have already been treated with 1 or 2 specific hormone-blocking drugs (called androgen receptor pathway inhibitors) and whose cancer progressed during or after that treatment.
  • People taking bone-strengthening medications (such as bisphosphonates or denosumab) must have been on a stable dose for at least 4 weeks before joining the trial.
  • People with a general health and activity level rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity), assessed within 10 days before joining.
  • People who have previously been treated with a type of drug called a PARP inhibitor, if that was recommended under local treatment guidelines, or who were assessed by the doctor as not suitable to receive one.

Who may not be able to join:

  • People who have a history of, or currently have, a non-infectious lung condition called interstitial lung disease or pneumonitis that needed steroid treatment, or where this condition is suspected.
  • People with serious breathing difficulties caused by ongoing lung illness.
  • People with uncontrolled or significant heart or blood vessel disease.
  • People with a history of problems with the pituitary gland.
  • People with poorly controlled diabetes.
  • People with a history of, or current, adrenal insufficiency (a condition where the adrenal glands do not produce enough hormones, such as Addison's disease).
  • People who have previously received a chemotherapy drug from the taxane family specifically for advanced prostate cancer that no longer responds to hormone therapy.
  • People who are on long-term steroid medication at a dose higher than 10 mg of prednisone (or equivalent) per day — low-dose inhaled steroids for asthma or lung disease, skin creams for mild skin conditions, and joint injections are generally exceptions (confirm with trial site).
  • People who have had radiotherapy within 2 weeks before starting the study treatment, or who still have side effects from radiation that require steroid treatment.
  • People who have another cancer that is currently growing or has needed active treatment within the past 3 years.
  • People with cancer that has spread to the brain or the lining around the brain or spinal cord.
  • People who have an active autoimmune disease that has needed systemic (whole-body) treatment within the past 2 years.
  • People who have had 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 12 July 2026
Phase 2: approximately ~30% 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

Phone: 1-888-577-8839

Australian sites

Macquarie University-MQ Health Clinical Trials Unit ( Site 0801), Macquarie University, New South Wales
+61 2 9812 2956

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
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
3 July 2025
Est. completion
1 April 2031

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇫🇷 France 🇩🇪 Germany 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Efficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only; Efficacy Phase: Number of Participants Who Experienced an Adverse Event (AE); Efficacy Phase: Number of Participants Who Discontinued Study Intervention Due to an AE; Efficacy Phase: Prostate-Specific Antigen (PSA) response rate; Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only; Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE) - Combination Arms Only; Safety Lea...

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: 12 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