Clinical Trials List
Protocol NumberMK-5684-003
NCT Number(ClinicalTrials.gov Identfier)NCT06136624
2024-01-01 - 2031-12-31
Phase III
Recruiting5
ICD-10C61
Malignant neoplasm of prostate
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9185
Malignant neoplasm of prostate
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
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Hsi-Chin Wu 無
- 邱鴻傑 無
- Chi-Shun Lien 無
- 蔡禮賢 無
- Po-Fan Hsieh 無
- Che-Hung Lin 無
- Chao-Hsiang Chang 無
- 陳冠亨 無
- 鄭富銘 無
- 謝德鈞 無
- Ching-Chan Lin 無
- Han Chang 無
- Chi-Rei Yang 無
- Po-Jen Hsiao 無
- Yu-De Wang 無
- Wei-Ching Lin 無
- Yi-Huei Chang 無
- Su-Peng Yeh 無
- 賴俊佑 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yung-Chang Lin 無
- 黃亮鋼 無
- See-Tong Pang 無
- 黃文冠 無
- I-hung Shao 無
- Hong-Cheng Gan 無
- Feng-Yuan Liu 無
- 吳俊德 無
- 張境夫 無
- 沈鼎文 無
- Yung-Chia Kao 無
- PO-HUNG LIN 無
- 余紹銘 無
- Kai-Jie Yu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Chieh Tsai 無
- CHING-CHU LU 無
- Ying-Chun Shen 無
- 闕士傑 無
- FU-JEN HSUEH 無
- CHUNG-HSIN CHEN 無
- JHE-CYUAN GUO 無
- - - 無
- 王中傑 無
- YEN-HENG LIN 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzu-chun Wei 無
- 蔡承翰 無
- William Huang 無
- Yen-Hwa Chang 無
- Tzu-Hao Huang 無
- Tzu-Ping Lin 無
- 陳威任 無
- Jia-An Hong 無
- 彭昱璟 無
- I-Shen Huang 無
- Chien-Hsin Ting 無
- Tzu-Hsiang Hsu 無
- Yi-Hsiu Huang 無
- Chih-Chieh Lin 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 詹皓程 無
- Wen-Pin Su 無
- Jiann-Hui Ou 無
- Che-Yuan Hu 無
- Kuan-Yu Wu 無
- 戴大堯 無
- 盧則宏 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Prostate Cancer Metastatic
Objectives
main purpose:
(1) Compare MK-5684 to alternatives abiraterone acetate or enzalutamide in terms of overall survival (OS) in subjects with mCRPC.
(2) Radiographic progression-free survival (rPFS) as assessed by a Blinded Independent Central Review Committee (BICR) in subjects with mCRPC based on Prostate Cancer Working Group (PCWG) revised RECIST 1.1, comparing MK-5684 to alternative Compare abiraterone acetate or enzalutamide.
Test Drug
MK-5684
Active Ingredient
MK-5684
Dosage Form
Tablet
Dosage
2.5 mg/tablet
Endpoints
‧ OS: time from random assignment to death from any cause.
‧ rPFS: time from random assignment to radiographic deterioration or death from any cause, whichever occurs first.
‧ rPFS: time from random assignment to radiographic deterioration or death from any cause, whichever occurs first.
Inclution Criteria
Inclusion Criteria:
1.Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
2.Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
3.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)
4.Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
5.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
6.Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
7.Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
8.Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
9.Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
10.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
11.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
12.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
13.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
14.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
15.Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
16.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 MK-5684, for at least 30 days after the last dose of abiraterone acetate, and for at least 30 days after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom
1.Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
2.Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
3.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)
4.Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
5.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
6.Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
7.Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
8.Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
9.Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
10.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
11.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
12.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
13.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
14.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
15.Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
16.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 MK-5684, for at least 30 days after the last dose of abiraterone acetate, and for at least 30 days after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom
Exclusion Criteria
Exclusion Criteria:
1.Has a gastrointestinal disorder that might affect absorption
2.Has a history of pituitary dysfunction
3.Has poorly controlled diabetes mellitus
4.Has clinically significant abnormal serum potassium or sodium level
5.Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events
6.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
7.Has a history of clinically significant ventricular arrhythmias
8.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
9.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
10.Participants who have not adequately recovered from major surgery or have ongoing surgical complications
11.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
12.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
13.Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
14.Has received colony-stimulating factors within 28 days before the date of randomization
15.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
16.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
17.Has a "superscan" bone scan
18.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
19.Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
20.Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
21.Has an active autoimmune disease that has required systemic treatment in past 2 years
22.Has an active infection requiring systemic therapy
23.Has concurrent active HBV or known active HCV infection
24.Has a history of long QTc syndrome
25.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
26.Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
27.Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
28.Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
29.Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
30.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])
30.Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention
1.Has a gastrointestinal disorder that might affect absorption
2.Has a history of pituitary dysfunction
3.Has poorly controlled diabetes mellitus
4.Has clinically significant abnormal serum potassium or sodium level
5.Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events
6.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
7.Has a history of clinically significant ventricular arrhythmias
8.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
9.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
10.Participants who have not adequately recovered from major surgery or have ongoing surgical complications
11.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
12.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
13.Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
14.Has received colony-stimulating factors within 28 days before the date of randomization
15.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
16.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
17.Has a "superscan" bone scan
18.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
19.Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
20.Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
21.Has an active autoimmune disease that has required systemic treatment in past 2 years
22.Has an active infection requiring systemic therapy
23.Has concurrent active HBV or known active HCV infection
24.Has a history of long QTc syndrome
25.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
26.Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
27.Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
28.Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
29.Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
30.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])
30.Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention
The Estimated Number of Participants
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Taiwan
30 participants
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Global
1200 participants
