Home/Get Matched/NCT06353386
Phase 1Recruiting
View on ClinicalTrials.gov

Comparing 4 approaches for castration-resistant prostatic neoplasms

Official title: 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)

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Condition: Prostatic Neoplasms, Castration-ResistantSponsor: Merck Sharp & Dohme LLCTarget enrollment: 220
  • Phase 1
  • 4 groups
  • Sites in Montreal and Québec
  • Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0200), Montreal, QuebecJewish General Hospital ( Site 0206), Montreal, QuebecCentre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207), Québec, Quebec

Interventions (7)

  • Medication

    Opevesostat

    Oral Tablet

  • Medication

    Olaparib

    Oral Tablet

  • Medication

    Docetaxel

    IV Infusion

Canadian Sites (3)

3 of 3 recruiting

  • Centre Hospitalier de l'Université de Montréal ( Site 0200)

    Montreal, Quebec

    Recruiting
  • Jewish General Hospital ( Site 0206)

    Montreal, Quebec

    Recruiting
  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207)

    Québec, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for32 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +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.
  • +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.
  • +The main inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
  • +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.
  • +Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for \>4 weeks before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
  • +Participants who experienced adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) due to previous anticancer therapies must have recovered to \<Grade 1 or baselineBaselineYour starting measurements, taken before treatment begins.Read more →.

Exclusion

  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Concurrent active HBV or HCV infections.
  • The main exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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.
  • Received a whole blood transfusion in the last 120 days before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (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 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.
  • 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 prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 4 groups in this study.

Group A receives Opevesostat, together with one or more of: Fludrocortisone acetate and Dexamethasone.

Registry label: A: Arm A1: Opevesostat

Group B receives Olaparib and Opevesostat, together with one or more of: Fludrocortisone acetate and Dexamethasone.

Registry label: B: Arm A2: Olaparib + Opevesostat

Group C receives Docetaxel and Opevesostat, together with one or more of: Fludrocortisone acetate, Dexamethasone and Prednisone.

Registry label: C: Arm A3: Docetaxel + Opevesostat

Group D receives Cabazitaxel and Opevesostat, together with one or more of: Fludrocortisone acetate, Dexamethasone and Prednisone.

Registry label: D: Arm A4: Cabazitaxel + Opevesostat

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 220 people.

The study is currently expected to finish around January 2029.

The main measurement is taken over: Up to approximately 28 days.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Number of participants who experience one or more dose-limiting toxicities (DLTs) — measured over Up to approximately 28 days.

Number of participants who experience one or more adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Up to approximately 46 months.

Number of participants who discontinue study intervention due to an AE — measured over Up to approximately 46 months.

Prostate-specific antigen (PSA) response rate — measured over Up to approximately 46 months.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06353386 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About OpevesostatDrug

Oral Tablet

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About OlaparibDrug

Oral Tablet

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About DocetaxelDrug

IV Infusion

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About CabazitaxelDrug

IV Infusion

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Fludrocortisone acetateDrug

Oral Tablet

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About DexamethasoneDrug

Oral Tablet

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About PrednisoneDrug

Oral Tablet

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Up to approximately 28 days.

The study as a whole is currently expected to finish around 2029-01-15.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 220 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 2 locations, including: Montreal, Quebec, Canada; Québec, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

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.

Think this trial might be right for you?

Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.

See if this trial could fit you

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.