Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
ConditionProstate Cancer Metastatic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Opevesostat
DrugAdministered orally
Abiraterone acetate
DrugAdministered orally
Enzalutamide
DrugAdministered orally
Hydrocortisone
DrugAdministered orally or IM as a rescue medication
Fludrocortisone acetate
DrugAdministered orally
Prednisone
DrugAdministered orally as a rescue medication
Dexamethasone
DrugAdministered orally as rescue medication
Treatment groups
1,310 Participants
are divided into 2 treatment groupsGroup A: OpevesostatExperimental treatment 5 interventions
Group B: Abiraterone Acetate or EnzalutamideActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants
OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-positive participants will be reported for each study arm.
Time frame
Up to ~54 months2
OS in AR LBD Mutation-Negative Participants
OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-negative participants will be reported for each study arm.
Time frame
Up to ~54 monthsSecondary outcomes
1
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD Mutation-Positive Participants
rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm.
Time frame
Up to ~36 months2
rPFS Per Prostate Cancer Working Group-modifiedRECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD Mutation-Negative Participants
rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm.
Time frame
Up to ~36 months3
Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST)
TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.
Time frame
Up to ~54 months4
Objective Response (OR)
OR is determined by PCWG-modified RECIST 1.1 as assessed by BICR.
Time frame
Up to ~54 monthsSponsors and contacts
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Source ClinicalTrials.gov