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Looking for participantsPhase1/Phase2

Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06353386

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Opevesostat (drug), Olaparib (drug), Docetaxel (drug), Cabazitaxel (drug)
How long the study runs
Study runs about 56 months (dates as stated)
About the drug or intervention
Opevesostat — drug: Oral Tablet · Olaparib — drug: Oral Tablet · Docetaxel — drug: IV Infusion · Cabazitaxel — drug: IV Infusion · Fludrocortisone acetate — drug: Oral Tablet · Dexamethasone — drug: Oral Tablet · Prednisone — drug: Oral Tablet
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
220
Started
2024-05-20
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for prostatic neoplasms, castration-resistant
  • • Phase1/Phase2 - 220 participants
  • • Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostatic neoplasms, castration-resistant

Where?

  • • Cambridge - Addenbrooke's Hospital ( Site 1902)
  • • Glasgow - The Beatson West of Scotland Cancer Centre ( Site 1904)
  • • Preston - Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
  • • London - University College London Hospital ( Site 1905)
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.

Prostatic Neoplasms, Castration-Resistant

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ 1 to 2 novel h
  • ✓ been on stable doses for \>4 weeks
  • ✓ recovered to \<Grade 1 or baseline
  • ✓ well controlled HIV on antiretroviral therapy

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓confirmed by testing a sample diagnosis of adenocarcinoma of the prostate without small cell histology.
  • ✓Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6...
  • ✓Current evidence of that has spread disease.
  • ✓Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been...

Who cannot take part

  • ✗The main exclusion criteria include but are not limited to the following:
  • ✗History of pituitary dysfunction.
  • ✗Poorly controlled diabetes mellitus.
  • ✗History or family history of long corrected QT interval (QTc) syndrome.
  • ✗Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
See the full criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology. * Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening. * Evidence of disease progression from either, \>4 weeks from last flutamide treatment, or \>6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy. * Current evidence of metastatic disease. * Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment. * Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for \>4 weeks before randomization. * Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to \<Grade 1 or baseline. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy. * Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load. * Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * History of pituitary dysfunction. * Poorly controlled diabetes mellitus. * Active or unstable cardio/cerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina * History or family history of long corrected QT interval (QTc) syndrome. * Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML. * History or current condition of adrenal insufficiency. * History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications. * Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention. * Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization). * Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. * Received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids. * Received a live or live-attenuated vaccine within 30 days before the first does of study intervention. Administration of killed vaccines is allowed. * Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Active autoimmune disease that has required systemic treatment in the past 2 years. * Active infection requiring systemic therapy. * Concurrent active HBV or HCV infections.

Where Is This Study? (5 UK sites)

Addenbrooke's Hospital ( Site 1902)

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441223216083

The Beatson West of Scotland Cancer Centre ( Site 1904)

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441413017070

Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)

Preston PR2 9HT, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Paul Brown

Research.Access@lthtr.nhs.uk01772 522031

University College London Hospital ( Site 1905)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442034472930

Queen Elizabeth Hospital Birmingham ( Site 1903)

Birmingham B15 2TH, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10