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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06136624




Registration number
NCT06136624
Ethics application status
Date submitted
13/11/2023
Date registered
18/11/2023
Date last updated
25/11/2024

Titles & IDs
Public title
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Scientific title
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
Secondary ID [1] 0 0
2023-504899-25
Secondary ID [2] 0 0
5684-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer Metastatic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Opevesostat
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Hydrocortisone
Treatment: Drugs - Fludrocortisone acetate
Treatment: Drugs - Prednisone
Treatment: Drugs - Dexamethasone

Experimental: Opevesostat - Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) dose will also be provided to participants for use as rescue medication.

Active comparator: Abiraterone Acetate or Enzalutamide - Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.


Treatment: Drugs: Opevesostat
Administered orally

Treatment: Drugs: Abiraterone acetate
Administered orally

Treatment: Drugs: Enzalutamide
Administered orally

Treatment: Drugs: Hydrocortisone
Administered orally or IM as a rescue medication

Treatment: Drugs: Fludrocortisone acetate
Administered orally

Treatment: Drugs: Prednisone
Administered orally

Treatment: Drugs: Dexamethasone
Administered orally as rescue medication
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants
Timepoint [1] 0 0
Up to ~54 months
Primary outcome [2] 0 0
OS in AR LBD Mutation-Negative Participants
Timepoint [2] 0 0
Up to ~54 months
Primary outcome [3] 0 0
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 Participant
Timepoint [3] 0 0
Up to ~36 months
Primary outcome [4] 0 0
rPFS Per Prostate Cancer Working Group-modified RECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD Mutation-Negative Participants
Timepoint [4] 0 0
Up to ~36 months
Secondary outcome [1] 0 0
Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST)
Timepoint [1] 0 0
Up to ~54 months
Secondary outcome [2] 0 0
Objective Response (OR)
Timepoint [2] 0 0
Up to ~54 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to ~54 months
Secondary outcome [4] 0 0
Time to Pain Progression (TTPP)
Timepoint [4] 0 0
Up to ~54 months
Secondary outcome [5] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [5] 0 0
Up to ~54 months
Secondary outcome [6] 0 0
Time to First Symptomatic Skeletal-related Event (SSRE)
Timepoint [6] 0 0
Up to ~54 months
Secondary outcome [7] 0 0
Number of Participants Who Experience an Adverse Event
Timepoint [7] 0 0
Up to ~54 months
Secondary outcome [8] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event
Timepoint [8] 0 0
Up to ~54 months

Eligibility
Key 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 metastatic 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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) 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-areductase 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/08/2028
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Dubbo Hospital ( Site 0235) - Dubbo
Recruitment hospital [2] 0 0
Macquarie University-MQ Health Clinical Trials Unit ( Site 0234) - Macquarie University
Recruitment hospital [3] 0 0
Westmead Hospital-Department of Medical Oncology ( Site 0232) - Westmead
Recruitment hospital [4] 0 0
Princess Alexandra Hospital-Cancer Care Serices ( Site 0237) - Brisbane
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230) - Melbourne
Recruitment postcode(s) [1] 0 0
2830 - Dubbo
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment outside Australia
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United States of America
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Colorado
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Jalisco
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Mexico
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Utrecht
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Hato Rey
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Ponce
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Cadiz
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State/province [163] 0 0
Taoyuan
Country [164] 0 0
Thailand
State/province [164] 0 0
Khon Kaen
Country [165] 0 0
Thailand
State/province [165] 0 0
Krung Thep Maha Nakhon
Country [166] 0 0
Thailand
State/province [166] 0 0
Songkhla
Country [167] 0 0
Turkey
State/province [167] 0 0
Adana
Country [168] 0 0
Turkey
State/province [168] 0 0
Ankara
Country [169] 0 0
Turkey
State/province [169] 0 0
Istanbul
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Cambridgeshire
Country [171] 0 0
United Kingdom
State/province [171] 0 0
England
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Glasgow City
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Hammersmith And Fulham
Country [174] 0 0
United Kingdom
State/province [174] 0 0
London, City Of
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Orion Corporation, Orion Pharma
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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) and to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria In Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) 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 and rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.
Trial website
https://clinicaltrials.gov/study/NCT06136624
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06136624