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A Study to Learn About the Investigational Medicine Called Mevrometostat (PF-06821497) in Men With Metastatic Castration-Sensitive Prostate Cancer Who Have Not Tried Novel Hormonal Therapy or Chemotherapy for Metastatic Prostate Cancer (MEVPRO-3)
EU CTIS ID: 2024-519369-24-00
What this study is testing
To demonstrate that mevrometostat in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging blinded independent central review (BICR)-assessed radiologic progression-free survival (rPFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male participants aged 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features (neuroendocrine differentiation and other histologic components are permitted if adenocarcinoma is the primary histology). For participants without a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis.
- Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI scan (for soft tissue/visceral disease).
- Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator’s judgement).
- Participants cannot have received any cytotoxic chemotherapy, ARPIs (eg, enzalutamide, apalutamide, abiraterone acetate, or darolutamide), any other systemic anticancer therapies for mCSPC, with the following exceptions: a.ADT (chemical or surgical) must be started prior to randomization and must continue throughout the study. Prior therapy with up to 3 months of ADT (with or without antiandrogens) is allowed with no radiographic evidence of disease progression or rising PSA levels indicative of disease progression prior to Day 1.; b. Treatment with estrogens, cyproterone acetate or first-generation antiandrogens is allowed until randomization, but must be discontinued prior to randomization.; c. Participants may have received 1 course of palliative radiation or surgery for symptomatic control secondary to prostate cancer, which should be completed at least 2 weeks prior to randomization.
- Participants must have ECOG PS 0 or 1.
You likely can't join if
- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Inability to swallow oral medications.
- Clinically significant cardiovascular disease, defined as: Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, or symptomatic pulmonary embolism or other clinically significant episode of thromboembolic disease, congenital long QT syndrome, Torsade de Pointes, clinically important arrhythmias, left anterior hemiblock (bifascicular block), ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, or other clinically significant cardiovascular disease as assessed by the investigator. If a participant has a cardiac rhythm device/pacemaker placed and QTcF >470 ms, the participant may be considered eligible. QTcF >480 ms on screening ECG.
- CNS pathology/neurological findings: a.Known or suspected brain metastasis or active leptomeningeal disease; b.Symptomatic or impending spinal cord compression or cauda equina syndrome; c.Participants with epidural disease, canal disease and prior cord involvement are NOT excluded if those areas have been treated, are stable and not neurologically impaired; d. Clinically significant history of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also history of unexplained loss of consciousness or transient ischemic attack within 12 months of randomization.
- Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy except for any of the following: a.Carcinoma in situ or nonmelanoma skin cancer.; b.Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage; c. Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator.
- In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption.
See the full eligibility criteria
Who can join
- Male participants aged 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features (neuroendocrine differentiation and other histologic components are permitted if adenocarcinoma is the primary histology). For participants without a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis.
- Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI scan (for soft tissue/visceral disease).
- Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator’s judgement).
- Participants cannot have received any cytotoxic chemotherapy, ARPIs (eg, enzalutamide, apalutamide, abiraterone acetate, or darolutamide), any other systemic anticancer therapies for mCSPC, with the following exceptions: a.ADT (chemical or surgical) must be started prior to randomization and must continue throughout the study. Prior therapy with up to 3 months of ADT (with or without antiandrogens) is allowed with no radiographic evidence of disease progression or rising PSA levels indicative of disease progression prior to Day 1.; b. Treatment with estrogens, cyproterone acetate or first-generation antiandrogens is allowed until randomization, but must be discontinued prior to randomization.; c. Participants may have received 1 course of palliative radiation or surgery for symptomatic control secondary to prostate cancer, which should be completed at least 2 weeks prior to randomization.
- Participants must have ECOG PS 0 or 1.
What rules you out
- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Inability to swallow oral medications.
- Clinically significant cardiovascular disease, defined as: Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, or symptomatic pulmonary embolism or other clinically significant episode of thromboembolic disease, congenital long QT syndrome, Torsade de Pointes, clinically important arrhythmias, left anterior hemiblock (bifascicular block), ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, or other clinically significant cardiovascular disease as assessed by the investigator. If a participant has a cardiac rhythm device/pacemaker placed and QTcF >470 ms, the participant may be considered eligible. QTcF >480 ms on screening ECG.
- CNS pathology/neurological findings: a.Known or suspected brain metastasis or active leptomeningeal disease; b.Symptomatic or impending spinal cord compression or cauda equina syndrome; c.Participants with epidural disease, canal disease and prior cord involvement are NOT excluded if those areas have been treated, are stable and not neurologically impaired; d. Clinically significant history of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also history of unexplained loss of consciousness or transient ischemic attack within 12 months of randomization.
- Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy except for any of the following: a.Carcinoma in situ or nonmelanoma skin cancer.; b.Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage; c. Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator.
- In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption.
- Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.
- Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- Prior treatment with: a.ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was <12 months prior to randomization and the total duration of ADT was >36 months; b. ARPI’s such as abiraterone, apalutamide, darolutamide, enzalutamide or other investigational ARPI’s; c.Cytochrome P17 enzyme inhibitors such as oral ketoconazole as anticancer treatments for prostate cancer; d. Chemotherapy including docetaxel or immunotherapy for prostate cancer.; e. Radiopharmaceuticals (ie, 177Lu-PSMA-617, radium-223); f. CDK4/6 inhibitors; g. Any other anticancer treatment for metastatic prostate cancer, excluding palliative radiotherapy/surgery and ADT as discussed above.
- Previous administration of an investigational product (drug or vaccine) which does not meet exclusion criterion 7 within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
- Inadequate renal function defined by an eGFR <45 mL/min/1.73 m2. Based upon participant age at screening, eGFR is calculated using the recommended formulas in Appendix 7 Section 10.7.2 to determine eligibility and to provide a baseline to quantify any subsequent kidney safety events. For eligibility assessment based upon estimated renal function, the higher of the screening and baseline eGFR values may be used.
- Major surgery (as defined by investigator) from which the participant has not fully recovered at least 28 days prior to randomization.
- Hepatic dysfunction defined as having any 1 of the following, which may be confirmed by a single repeat test, if necessary: a. Total bilirubin ≥1.5 x ULN (≥3 x ULN for participants with documented Gilbert’s syndrome, direct bilirubin >ULN is exclusionary) b. AST >2.5 x ULN c. ALT >2.5 x ULN
- Hematologic abnormalities defined as having any 1 of the following, which may be confirmed by a single repeat test, if necessary: a. ANC <1500/mm3; b. Platelets <100,000/mm3, independent of transfusion within 14 days of randomization; c. Hemoglobin <9 g/dL, independent of transfusion within 14 days of randomization
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Brazil
- United Kingdom
- Switzerland
- Taiwan
- Israel
- Canada
- Turkey
- Japan
- Australia
- New Zealand
- United States
- China
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Brazil; United Kingdom; Switzerland; Taiwan; Israel and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.