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A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

StatusRecruiting
PhasePhase 3
Started2023-12-18
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Merck (MSD)

Amendment history

The 50 most recent of 78 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-08-20
Study Status, Contacts/Locations v77
Primary endpoint(s) modified1 entry, revised
WasRadiographic Progression-Free Survival (rPFS)
NowOverall Survival (OS)
Study sites329→330
2026-08-12
Study Status, Contacts/Locations v76
Study sitesdetails revised at 14 of 329 sites
2026-07-21
Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v75
Eligibility criteria-14 characters
[...] ated AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 os [...]
Study sitesdetails revised at 8 of 329 sites
Collaborators-31 characters
Orion Corporation, Orion Pharma
2026-06-05
Study Status, Contacts/Locations v74
Study sites327→329
2026-06-01
Study Status, Contacts/Locations v73
Trial sites expanded: 324 → 327 locations
Show 45 earlier versions
2026-05-25
Study Status, Contacts/Locations v72
Study sitesdetails revised at 3 of 324 sites
2026-05-15
Study Status, Contacts/Locations v71
Study sitesdetails revised at 8 of 324 sites
2026-05-08
Study Status, Contacts/Locations v70
Study sitesdetails revised at 5 of 324 sites
2026-05-04
Study Status, Contacts/Locations v69
Study sitesdetails revised at 3 of 324 sites
2026-04-24
Study Status, Contacts/Locations v68
Study sites323→324
2026-04-20
Study Status, Contacts/Locations v67
Study sitesdetails revised at 4 of 323 sites
2026-04-13
Study Status, Contacts/Locations v66
Study sites322→323
2026-04-06
Study Status, Contacts/Locations v65
Study sitesdetails revised at 8 of 322 sites
2026-03-27
Study Status, Contacts/Locations v64
Study sites320→322
2026-03-20
Study Status, Contacts/Locations v63
Study sitesdetails revised at 3 of 320 sites
2026-03-06
Study Status, Contacts/Locations v62
Study sitesdetails revised at 6 of 320 sites
2026-02-27
Study Status, Contacts/Locations v61
Study sitesdetails revised at 6 of 320 sites
2026-02-20
Study Status, Contacts/Locations v60
Study sitesdetails revised at 3 of 320 sites
2026-02-13
Study Status, Contacts/Locations v59
Study sitesdetails revised at 11 of 320 sites
2026-02-09
Study Status, Contacts/Locations v58
Study sitesdetails revised at 8 of 320 sites
2026-01-30
Study Status, Contacts/Locations v57
Study sitesdetails revised at 2 of 320 sites
2026-01-23
Study Status, Contacts/Locations v56
Study sitesdetails revised at 3 of 320 sites
2026-01-16
Study Status, Contacts/Locations v55
Study sitesdetails revised at 7 of 320 sites
2026-01-09
Study Status, Contacts/Locations v54
Study sitesdetails revised at 19 of 320 sites
2026-01-02
Study Status, Contacts/Locations v53
Study sitesdetails revised at 26 of 320 sites
2025-12-18
Study Status, Contacts/Locations v52
Study sitesdetails revised at 46 of 320 sites
2025-11-18
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v51
Trial statusActive, Not Recruiting→Recruiting
Study sites319→320
2025-10-01
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v50
Primary completion date2030-12-02→2028-05-10
Enrollment target1500→1314
Eligibility criteria+15 characters
[...] adenocarcinoma of the prostate without small cell histology Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography scan (CT)/magnetic resonance imaging (MRI) Has prostate cancer progression while receiving androgen dep [...] ost 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 shown by computed tomography (CT)/magnetic resonance imaging (MRI) Has d [...] [...]
Secondary endpoints12 to 13 entries
Prostrate-specificOverall AntigenSurvival (OS) PSA) Response Rate Time to firstFirst symptomaticSymptomatic skeletalSkeletal-relatedRelated eventEvent (TSSRE) Number of Participants Who Experience an Adverse Event (AE)
Primary endpoints2 to 1 entries
Overall Survival (OS) Radiographic Progression-freeFree Survival (rPFS)
Study description+93 characters
Per Protocol Amendment 08, overall survival (OS) was moved to be a secondary outcome measure.
2025-09-15
Study Status v49
Re-verified, no change to tracked fields
2025-08-25
Study Status, Contacts/Locations v48
Study sites319 entries, revised
UrologyTrillium ClinicsHealth ofPartners North- Texas,Credit PLLCValley Hospital ( Site 00770289)
2025-08-25
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v47
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 319 of 319 sites
2025-08-14
Study Status, Contacts/Locations v46
Study sitesdetails revised at 2 of 319 sites
2025-08-01
Study Status, Contacts/Locations v45
Study sites317→319
2025-07-25
Study Status, Eligibility, Contacts/Locations v44
Study sites316→317
Eligibility criteria+21 characters
[...] ostate without small cell histology Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft [...]
2025-07-11
Study Status, Contacts/Locations v43
Study sites315→316
2025-07-04
Study Status, Contacts/Locations v42
Study sitescontacts updated at 3 of 315 sites
2025-06-26
Study Status, Contacts/Locations v41
Study sites312→315
2025-06-20
Study Status, Contacts/Locations v40
Study sites311→312
2025-06-11
Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 311 sites
2025-06-06
Study Status, Contacts/Locations v38
Study sites309→311
2025-05-28
Study Status, Contacts/Locations v37
Study sites308→309
2025-05-15
Study Identification, Study Status, Contacts/Locations v36
Study sites308 entries, revised
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( SiSite 0211) Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 00277) Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( SSite 1615) klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( SitSite 0521) ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( SitSite 0552) Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egy [...] [...]
2025-05-08
Study Status, Contacts/Locations v35
Study sites307→308
2025-04-30
Study Status, Contacts/Locations v34
Study sites306→307
2025-04-23
Study Identification, Study Status, Eligibility, Contacts/Locations v33
Study sites304→306
Eligibility criteria+213 characters
[...] non metastatic hormone sensitive prostate cancer (nmHSPC), or castration-resistant prostate cancer (CRPC) metastatic castration-resistant prostate cancer (mCRPC) or non-metastatic castration-resistant prostate cancer (nmCRPC), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression) Note: Participants [...] y group (ECOG) performance status of 0 or 1 assessed within 710 days before randomization Has ongoing androgen deprivation therapy (ADT) with serum testosterone <50 ng/dL (<1.7 nM) Has had prior t [...] therapy (HRT) or participants who have ≤Gr [...]
2025-04-09
Study Status, Contacts/Locations v32
Study sites302→304
2025-04-01
Study Status, Contacts/Locations v31
Study sites294→302
2025-03-06
Study Identification, Study Status, Contacts/Locations, IPDSharing v30
Study sites281→294
2025-01-09
Study Status, Contacts/Locations v29
Study sites278→281
2024-12-26
Study Status, Contacts/Locations v28
Study sites267→278
Merck (MSD)
401 trials monitored
See 24 trials at risk
Prostate Cancer
2,471 trials monitored
See 156 trials at risk
The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.
Trial Details
NCT Number NCT06136650
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms
Enrollment 1,314 participants
Start Date 2023-12-18
Primary Completion 2028-05-10 (estimated)
Study Completion 2030-12-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-25