D075 Prostate Prostate
Conditions
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1_ Has histologically- or cytologically-confirmed (if acceptable according to local health authority regulations) adenocarcinoma of the prostate without small cell histology. Diagnosis must be stated in a pathology report and confirmed by the investigator. 2_ Has metastatic disease as assessed by investigator and verified by BICR (prior to randomization) by either =2 bone lesions on bone scan and/or visceral disease (eg, lung or liver) by CT/MRI. Participants whose metastatic disease is limited to lymph nodes are not eligible. 3_ Once randomized, participant must be willing to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy. 4_ Has an ECOG performance status of 0 or 1 assessed within 10 days of randomization. 5_ Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for =4 weeks prior to randomization. 6_ Demonstrates adequate organ function as defined in Table 4; all screening labs should be performed in central laboratory within 10 days of the first dose of study intervention. 7_ Is male, =18 years of age at the time of signing the informed consent. 8_ Male participants are eligible to participate if they agree to the following during the intervention period and for at least 120 days after the last dose of study intervention. 9_ Male participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex. 10_ The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study. Please refer to the protocol for more information.
Exclusion criteria
Exclusion criteria: 1. Has a known additional malignancy that is progressing or has required active treatment in the last 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded. 2. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. 4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. 5. Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications. 6. Has a gastrointestinal disorder affecting absorption (eg, gastrectomy, active peptic ulcer disease within last 3 months). 7. Is unable to swallow tablets/capsules. 8. Has an active infection (including tuberculosis) requiring systemic therapy. 9. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 10. Has known active HIV, hepatitis B virus (eg, hepatitis B surface antigen reactive) or HCV (eg, HCV RNA [qualitative] is detected). Testing for Hepatitis B and Hepatitis C is not required unless mandated by local regulation. 11. Has known or suspected CNS metastases and/or carcinomatous meningitis. 12. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. 13. Has a history of seizure or any condition that may predispose to seizure (including, but not limited to prior cerebrovascular accident, transient ischemic attack, or brain arteriovenous malformation; or intracranial masses such as a schwannoma or meningioma that is causing edema or mass effect). 14. Has a history of loss of consciousness within 12 months of the Screening Visit. 15. Has had myocardial infarction or uncontrolled angina within 6 months prior to randomization. 16. Has New York Heart Association class III or IV congestive heart failure or a history of New York Heart Association class III or IV congestive heart failure. 17. Has a history of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes). 18. Has a history of Mobitz II second degree or third degree heart block without a permanent pacemaker in place. 19. Has hypotension as indicated by systolic blood pressure 170 mm Hg or diastolic blood pressure >105 mm Hg at the Screening visit. 22. Has sev
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kaplan-Meier Method NAME OF THE RESULT: Radiographic progression-free survival (rPFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Interim analyses for rPFS will occur approximately every 7 months until 53 months starting at month 32 and then every 12 months until at least 652 rPFS events have accrued.;Kaplan-Meier Method NAME OF THE RESULT: Overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After final rPFS analysis, analyses for OS will occur approximately every 12 months until at least 600 OS events achieved. Predicted to occur approximately 77 months after first participant enrolled. | — |
Secondary
| Measure | Time frame |
|---|---|
| Kaplan-Meier Method NAME OF THE RESULT: Radiographic progression-free survival (rPFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Interim analyses for rPFS will occur approximately every 7 months until 53 months starting at month 32 and then every 12 months until at least 652 rPFS events have accrued.;Kaplan-Meier Method NAME OF THE RESULT: Overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After final rPFS analysis, analyses for OS will occur approximately every 12 months until at least 600 OS events achieved. Predicted to occur approximately 77 months after first participant enrolled.;Kaplan-Meier Method NAME OF THE RESULT: time to initiation of the first subsequent anti-cancer therapy (TFST) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Until approximately 65 months after the randomization of the first participant starting at month 32 months after the randomization of the first participant.;Kaplan-Meier Method NAME OF THE RESULT: Time to symptomatic skeletal-related event (TTSSRE) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After final rPFS analysis, analyses for OS and TTSSRE will occur approximately every 12 months until at least 600 OS events achieved. An analysis may be delayed up to 3 months if 600 OS events predicted to accrue in that time window. | — |
Countries
Australia, Austria, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan, Korea South, Netherlands, New Zealand, Poland, Russian Federation, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kindgdom, United States
Outcome results
None listed