Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)
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
This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology. * Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening * Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI). * Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA) * Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment * Has ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<1.7 nM) * Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization * Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment * Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment * Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment * If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression \>4 weeks since the last flutamide treatment and \>6 weeks since the last bicalutamide or nilutamide treatment * Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization * Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART) * 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 before randomization * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening. * Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom Exclusion Criteria: * Has a gastrointestinal disorder that might affect absorption * Has a history of pituitary dysfunction * Has poorly controlled diabetes mellitus * Has clinically significant abnormal serum potassium or sodium level * Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events * Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization * Has a history of clinically significant ventricular arrhythmias * Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization * Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications * Participants who have not adequately recovered from major surgery or have ongoing surgical complications * Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization * Has received radium-223 or Lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or Lutetium-177 administered more than 4 weeks before the date of randomization * Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization * Has received colony-stimulating factors within 28 days before the date of randomization * Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization * Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks * Has a "superscan" bone scan * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has an active infection requiring systemic therapy * Has concurrent active HBV or known active HCV infection * Has a history of long QTc syndrome * Has any of the following at Screening Visit: hypotension (systolic BP \<110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy) * Is unable to swallow capsules/tablets * Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures * Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention * Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention * 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 dose of study intervention * Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle \[Silybum marianum\]) * Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention
Study sites (48)
CA
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) · Orange, CA 92868More trials in Orange
- Stanford Cancer Center ( Site 0036) · Palo Alto, CA 94304Study Coordinator · Study contact · 650-725-2078More trials in Palo Alto
- Kaiser Permanente Riverside Medical Center ( Site 0099) · Riverside, CA 92505Study Coordinator · Study contact · 951-809-8361More trials in Riverside
CO
- Anschutz Cancer Pavilion ( Site 0046) · Aurora, CO 80045Study Coordinator · Study contact · 302-290-3598More trials in Aurora
- University of Colorado Health - Highlands Ranch Hospital ( Site 0111) · Highlands Ranch, CO 80129Study Coordinator · Study contact · 302-290-3598More trials in Highlands Ranch
- Colorado Clinical Research ( Site 0067) · Lakewood, CO 80228More trials in Lakewood
- University of Colorado Health - Lone Tree Medical Center ( Site 0112) · Lone Tree, CO 80124Study Coordinator · Study contact · 720-848-5146More trials in Lone Tree
CT
- Yale-New Haven Hospital-Yale Cancer Center ( Site 0064) · New Haven, CT 06510Study Coordinator · Study contact · 203-737-8076More trials in New Haven
FL
- Florida Cancer Specialists - South ( Site 7003) · Fort Myers, FL 33901More trials in Fort Myers
- Bruce W. Carter Veterans Affairs Medical Center ( Site 0082) · Miami, FL 33125More trials in Miami
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051) · Miami, FL 33136Study Coordinator · Study contact · 305-243-1543More trials in Miami
IA
- University of Iowa ( Site 0047) · Iowa City, IA 52242More trials in Iowa City
IL
- University of Illinois at Chicago ( Site 0105) · Chicago, IL 60612Study Coordinator · Study contact · 973-330-2391More trials in Chicago
- University of Chicago Medical Center ( Site 0045) · Chicago, IL 60637Study Coordinator · Study contact · 773-702-7609More trials in Chicago
KY
- University of Kentucky Chandler Medical Center ( Site 0048) · Lexington, KY 40536More trials in Lexington
LA
- Ochsner Clinic Foundation ( Site 0108) · New Orleans, LA 70121More trials in New Orleans
MD
- Baltimore Veterans Affairs Medical Center ( Site 0069) · Baltimore, MD 21201Study Coordinator · Study contact · 410-707-4011More trials in Baltimore
- Greenebaum Comprehensive Cancer Center ( Site 0049) · Baltimore, MD 21201Study Coordinator · Study contact · 410-707-4011More trials in Baltimore
MI
- Henry Ford Hospital ( Site 0015) · Detroit, MI 48202More trials in Detroit
MN
- Avera Cancer Institute - Marshall ( Site 0122) · Marshall, MN 56258Study Coordinator · Study contact · 605-601-1830More trials in Marshall
- M Health Fairview Clinics and Surgery Center ( Site 0019) · Minneapolis, MN 55455Study Coordinator · Study contact · 612-626-1422More trials in Minneapolis
- Metro-Minnesota Community Clinical Oncology ( Site 0014) · Saint Louis Park, MN 55416More trials in Saint Louis Park
MO
- Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062) · St Louis, MO 63110Study Coordinator · Study contact · 314-286-2341More trials in St Louis
MS
- Hattiesburg Clinic Hematology/Oncology ( Site 0120) · Hattiesburg, MS 39401Study Coordinator · Study contact · 601-261-1700More trials in Hattiesburg
NE
- University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095) · Omaha, NE 68105Study Coordinator · Study contact · 402-559-8500More trials in Omaha
NJ
- Atlantic Health System Morristown Medical Center ( Site 0115) · Morristown, NJ 07960Study Coordinator · Study contact · 973-971-7960More trials in Morristown
- Rutgers Cancer Institute of New Jersey ( Site 0033) · New Brunswick, NJ 08903More trials in New Brunswick
NV
- Comprehensive Cancer Centers of Nevada ( Site 0010) · Las Vegas, NV 89148Study Coordinator · Study contact · 702-952-1251More trials in Las Vegas
NY
- James J. Peters VA Medical Center ( Site 0088) · The Bronx, NY 10468Study Coordinator · Study contact · 718-584-9000More trials in The Bronx
OH
- University Hospitals Cleveland Medical Center ( Site 0043) · Cleveland, OH 44106Study Coordinator · Study contact · 216-844-3951More trials in Cleveland
OR
- Oregon Health and Science University ( Site 0028) · Portland, OR 97239More trials in Portland
- VA Portland Health Care System ( Site 0058) · Portland, OR 97239Study Coordinator · Study contact · 503-220-8262More trials in Portland
PA
- AHN Allegheny General Hospital ( Site 0001) · Pittsburgh, PA 15212More trials in Pittsburgh
SC
- Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083) · Charleston, SC 29401More trials in Charleston
SD
- Avera Cancer Institute - Aberdeen ( Site 0123) · Aberdeen, SD 57401Study Coordinator · Study contact · 605-601-1830More trials in Aberdeen
- Avera Cancer Institute - Mitchell ( Site 0121) · Mitchell, SD 57301Study Coordinator · Study contact · 605-601-1830More trials in Mitchell
- Avera Cancer Institute - Pierre ( Site 0118) · Pierre, SD 57501Study Coordinator · Study contact · 605-224-3370More trials in Pierre
- Avera Cancer Institute- Research ( Site 0094) · Sioux Falls, SD 57105Study Coordinator · Study contact · 605-322-6900More trials in Sioux Falls
- Avera Cancer Institute - Yankton ( Site 0117) · Yankton, SD 57078Study Coordinator · Study contact · 605-655-1800More trials in Yankton
TN
- SCRI Oncology Partners ( Site 7000) · Nashville, TN 37203Study Coordinator · Study contact · 615-218-4647More trials in Nashville
TX
- Texas Oncology - Central/South Texas ( Site 8003) · Austin, TX 78731Study Coordinator · Study contact · 512-427-9400More trials in Austin
- Texas Oncology - DFW ( Site 8001) · Dallas, TX 75246More trials in Dallas
- Texas Oncology - Gulf Coast ( Site 8002) · Houston, TX 77024Study Coordinator · Study contact · 713-467-1722More trials in Houston
VA
- University of Virginia Health System ( Site 0054) · Charlottesville, VA 22908Study Coordinator · Study contact · 434-327-3029More trials in Charlottesville
- VCU Health Adult Outpatient Pavillion ( Site 0061) · Richmond, VA 23219More trials in Richmond
- Blue Ridge Cancer Care ( Site 0004) · Roanoke, VA 24014Study Coordinator · Study contact · 540-982-0237More trials in Roanoke
WA
- Fred Hutchinson Cancer Center ( Site 0013) · Seattle, WA 98109Study Coordinator · Study contact · 617-413-9079More trials in Seattle
WI
- Medical College of Wisconsin ( Site 0020) · Milwaukee, WI 53226Study Coordinator · Study contact · 414-805-4600More trials in Milwaukee