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Opevesostat-Based Treatments for Prostate Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology

Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for >4 weeks before randomization

Must not have

History of pituitary dysfunction

Poorly controlled diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 46 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is a part of a larger study focusing on experimental treatments for advanced prostate cancer. The specific goal of this substudy is to assess the safety and effectiveness of using opevesostat alone

Who is the study for?

This trial is for men with advanced prostate cancer that has spread and resisted hormone therapy. They should have tried up to two new hormonal treatments, be past certain previous treatments by specific times, and show current metastatic disease. Stable on bone treatment for over 4 weeks, recovered from prior therapy side effects to mild levels or normal, and if they have Hepatitis B or C or HIV, these must be well-managed.

What is being tested?

The study tests Opevesostat alone or combined with other drugs (Docetaxel, Dexamethasone, Fludrocortisone acetate, Olaparib, Prednisone, Cabazitaxel) in treating metastatic castration-resistant prostate cancer. It includes a safety phase to find the right dose followed by an efficacy phase without hypothesis testing.

What are the potential side effects?

While not specified here, common side effects of cancer treatments like those being tested may include fatigue; nausea; hair loss; skin changes; increased risk of infection due to lowered immunity; blood clots; diarrhea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is confirmed without being a small cell type.

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I have been on a stable dose of medication for bone health for more than 4 weeks.

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I have recovered from side effects of previous cancer treatments.

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My cancer has spread to other parts of my body.

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My prostate cancer progressed despite 1-2 treatments with new hormone therapies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had issues with my pituitary gland.

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My diabetes is not well-managed.

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I do not have any active heart or brain blood vessel problems.

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I or my family have a history of long QT syndrome.

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I have or had adrenal insufficiency.

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I have had pneumonitis treated with steroids or have it now.

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I am HIV-positive and have had Kaposi's sarcoma or Multicentric Castleman's Disease.

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I haven't had radiotherapy or needed steroids for side effects in the last 2 weeks.

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I have active brain metastases or cancer in my brain's lining.

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I have been treated for an autoimmune disease in the last 2 years.

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I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.

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I had major surgery, excluding prostate biopsy, within the last 28 days and am still recovering.

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I haven't had a whole blood transfusion in the last 120 days.

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I have not taken steroids or immunosuppressants in the last 7 days.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 46 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 46 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 46 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants who discontinue study intervention due to an AE

Number of participants who experience one or more adverse events (AEs)

Number of participants who experience one or more dose-limiting toxicities (DLTs)

+1 more

Secondary study objectives

Duration of response (DOR)

Objective response rate (ORR)

Overall survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm A4: Cabazitaxel + OpevesostatExperimental Treatment5 Interventions

Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 20 mg/m\^2 of cabazitaxel Q3W via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.

Group II: Arm A3: Docetaxel + OpevesostatExperimental Treatment5 Interventions

Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 75 mg/m\^2 of docetaxel once every 3 weeks (Q3W) via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.

Group III: Arm A2: Olaparib + OpevesostatExperimental Treatment4 Interventions

Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 300 mg of olaparib BID via oral tablet until progressive disease or discontinuation.

Group IV: Arm A1: OpevesostatExperimental Treatment3 Interventions

Participants receive 5 mg of opevesostat twice daily (BID) via oral tablet plus dexamethasone 1.5 mg by oral tablets once daily (QD) and 0.1 mg fludrocortisone acetate by oral tablet QD until progression or discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

Dexamethasone

2007

Completed Phase 4

~2650