Clinical Trials List
Protocol NumberMK-5684-01A
NCT Number(ClinicalTrials.gov Identfier)NCT06353386
Active
2024-03-01 - 2031-12-31
Phase I/II
Recruiting4
MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (OMAHA-01A)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
MERCK SHARP & DOHME (I.A.) LLC. TAIWAN BRANCH (U.S.A.)
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Han Chang Division of General Surgery
- 謝德鈞 Division of Nuclear Medicine
- Wei-Ching Lin Division of Radiology
- Chi-Rei Yang Division of Urology
- Chi-Ping Huang Division of Urology
- Chao-Hsiang Chang Division of Urology
- Po-Fan Hsieh Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Chieh Lin Division of Urology
- Tzu-Hsiang Hsu Division of Urology
- William Huang 無
- Tzu-chun Wei 無
- Chien-Hsin Ting Division of Nuclear Medicine
- Jia-An Hong Division of Radiology
- 彭昱璟 Division of Others
- 蔡承翰 無
- Liang-Yu Lin Division of Endocrinology
- 陳威任 無
- Tzu-Ping Lin Division of Urology
- Yen-Hwa Chang Division of Urology
- Tzu-Hao Huang 無
- Hsiao-Jen Chung 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Po-Jung Su
Co-Principal Investigator
- 余紹銘 Division of Hematology & Oncology
- PO-HUNG LIN Division of Hematology & Oncology
- See-Tong Pang Division of Hematology & Oncology
- Feng-Yuan Liu Division of Hematology & Oncology
- 沈鼎文 Division of Hematology & Oncology
- 張境夫 Division of Hematology & Oncology
- 黃亮鋼 Division of Hematology & Oncology
- 吳俊德 Division of Hematology & Oncology
- I-hung Shao Division of Hematology & Oncology
- 黃文冠 Division of Hematology & Oncology
- Hong-Cheng Gan Division of Hematology & Oncology
- Yung-Chang Lin Division of Hematology & Oncology
- Yung-Chia Kao Division of Hematology & Oncology
- Kai-Jie Yu
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Objectives
Primary Outcome Measures
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Number of participants who experience one or more adverse events (AEs)
Number of participants who discontinue study intervention due to an AE
Prostate-specific antigen (PSA) response rate
Secondary Outcome Measures
Objective response rate (ORR)
Radiographic progression-free survival (rPFS)
Overall survival (OS)
Duration of response (DOR)
Time to first subsequent anticancer therapy (TFST)
Time to pain progression (TTPP)
Test Drug
MK-5684
Active Ingredient
MK-5684
Dosage Form
tablets
Dosage
2.5 mg
Endpoints
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Number of participants who experience one or more adverse events (AEs)
Number of participants who discontinue study intervention due to an AE
Prostate-specific antigen (PSA) response rate
Number of participants who experience one or more adverse events (AEs)
Number of participants who discontinue study intervention due to an AE
Prostate-specific antigen (PSA) response rate
Inclution Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
• Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology.
• Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
• Evidence of disease progression from either, >4 weeks from last flutamide treatment, or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.
• Current evidence of metastatic disease.
• Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
• Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for >4 weeks before randomization.
• Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to
• 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.
• Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
The main inclusion criteria include but are not limited to the following:
• Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology.
• Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
• Evidence of disease progression from either, >4 weeks from last flutamide treatment, or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.
• Current evidence of metastatic disease.
• Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
• Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for >4 weeks before randomization.
• Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to
• 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.
• Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
Exclusion Criteria
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
• History of pituitary dysfunction.
• Poorly controlled diabetes mellitus.
• Active or unstable cardio/cerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina
• History or family history of long corrected QT interval (QTc) syndrome.
• Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
• History or current condition of adrenal insufficiency.
• History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
• Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications.
• Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.
• Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).
• Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
• 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 does of study intervention. Administration of killed vaccines is allowed.
• Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Active autoimmune disease that has required systemic treatment in the past 2 years.
• Active infection requiring systemic therapy.
• Concurrent active HBV or HCV infections.
The main exclusion criteria include but are not limited to the following:
• History of pituitary dysfunction.
• Poorly controlled diabetes mellitus.
• Active or unstable cardio/cerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina
• History or family history of long corrected QT interval (QTc) syndrome.
• Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
• History or current condition of adrenal insufficiency.
• History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
• Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications.
• Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.
• Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).
• Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
• 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 does of study intervention. Administration of killed vaccines is allowed.
• Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Active autoimmune disease that has required systemic treatment in the past 2 years.
• Active infection requiring systemic therapy.
• Concurrent active HBV or HCV infections.
The Estimated Number of Participants
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Taiwan
14 participants
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Global
220 participants
