RecruitingPhase 1 / Phase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests opevesostat alone or with other drugs for prostate cancer that has spread and keeps growing despite treatment to lower testosterone. It will check how safe the treatments are, how well they work, and what dose to use for the drug combinations.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests must show prostate adenocarcinoma, a type of prostate cancer, with no small cell cancer. The cancer must have spread.
  • Your cancer has gotten worse, and you had hormone-lowering treatment or surgery to remove both testicles within 6 months before screening.
  • If your last treatment was flutamide, the cancer must worsen more than 4 weeks after stopping it. For bicalutamide or nilutamide, the wait is more than 6 weeks.
  • You have had 1 or 2 newer hormone drugs, and your cancer got worse during or after treatment.
  • If you take medicine to slow bone loss, your dose must be stable for more than 4 weeks before study group assignment.
  • Side effects from past cancer treatments must be gone or back to your usual level.
  • If you have HIV, it must be well controlled with HIV medicine.
  • If you test positive for hepatitis B, you need at least 4 weeks of treatment and no virus found in blood tests. If you have had hepatitis C, no virus can be found in blood tests.

Who can't join

  • Past pituitary gland problems, past or current low adrenal gland function, or poorly controlled diabetes. These glands help control hormones.
  • Active or unstable heart or blood vessel disease, certain serious heart conditions, or a stroke, mini-stroke, or heart attack in the past 6 months.
  • You or a family member has long QT syndrome, a heart rhythm problem.
  • Certain bone marrow disorders or blood cancers called MDS or AML, or signs of these diseases.
  • Current lung inflammation, or past lung inflammation not caused by infection that needed steroid treatment.
  • A weak immune system, recent treatment that lowers immune defenses, or an autoimmune disease needing whole-body treatment in the past 2 years.
  • Another cancer that is growing or needed treatment in the past 3 years, or active cancer spread to the brain, spinal cord, or their lining.
  • An active infection needing whole-body treatment, both hepatitis B and C active at the same time, or HIV with a history of Kaposi's sarcoma or Multicentric Castleman's disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (7)

CA

FL

  • University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051) · Miami, FL 33136Study Coordinator · Study contact · 305-243-1543More trials in Miami

MD

  • University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049) · Baltimore, MD 21201More trials in Baltimore

NJ

OH

WI