NCT06551324进行中（未招募）3 期
A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 600
- 试验地点
- 378
- 主要终点
- Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
研究概览
简要总结
Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment.
The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
- •Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
- •Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
- •Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
排除标准
- •Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant inappropriate for the study.
- •Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
- •Clinically significant cardiovascular disease.
- •Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
- •Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy, CDK4/6 inhibitors, or other systemic anti-cancer treatment, with the following exceptions:
- •Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
- •Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
- •Use of 5-alpha reductase inhibitors within 28 days of randomization.
- •Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
- •Inadequate organ function.
研究组 & 干预措施
Arm A
Experimental
Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)
干预措施: Enzalutamide (Drug)
Arm A
Experimental
Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)
干预措施: PF-06821497 (Drug)
Arm B
Active Comparator
Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days
干预措施: Enzalutamide (Drug)
Arm B
Active Comparator
Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days
干预措施: Docetaxel (Drug)
结局指标
主要结局
Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
时间窗: Randomization up to approximately 2 years.
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.
次要结局
- Overall survival (OS)(Randomization up to approximately 4.5 years.)
- Objective Response (ORR)(Randomization up to approximately 2 years.)
- Time to first symptomatic skeletal event(Randomization up to approximately 2 years.)
- Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)(Randomization up to approximately 4.5 years)
- Duration of Response (DoR) in measurable soft tissue disease(Randomization up to approximately 2 years.)
- Prostate Specific Antigen Response(Randomization up to approximately 2 years.)
- Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization to approximately 4.5 years)
- Time to prostate specific antigen (PSA) progression.(Randomization up to approximately 2 years.)
- Time to initiation of antineoplastic therapy.(Randomization up to approximately 4.5 years.)
- Incidence of Adverse Events(Randomization up to approximately 4.5 years)
- Change from baseline in emotional well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization up to approximately 4.5 years)
- Change from baseline in social/family well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization up to approximately 4.5 years)
- Change from baseline in functioning well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization up to approximately 4.5 years)
- Change from baseline in physical well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization to approximately 4.5 years)
- Change from baseline in symptoms per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization up to approximately 4.5 years)
- Time to confirmatory deterioration in patient-reported pain symptoms per BPI-SF Item 3 "worst pain in 24 hours"(Randomization up to approximately 4.5 years)
- Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (EQ-5D-5L)(Randomizaton up to approximately 4.5 years)
- Time to definitive deterioration in patient-reported physical well-being per FACT-P(Randomization up to approximately 4.5 years)
- Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)(Randomization up to approximately 4.5 years)
- Overall side effect burden as measured by the FACT- GP5(Randomization to approximately 4.5 years)
- Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P(Randomization up to approximately 4.5 years)
- To evaluate the PK of PF-06821497 when dosed with enzalutamide(Cycle 1 (each cycle is 28 days), Day 1 to last PK draw at the end of Cycle 6, Day 1.)
- To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden.(Baseline up to approximately 2 years.)
研究者
研究点 (378)
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相关资讯
Phase III Trial MEVPRO-1 Evaluates Mevrometostat Plus Enzalutamide in mCRPC Post-Abiraterone- MEVPRO-1 is a phase III trial assessing mevrometostat with enzalutamide for metastatic castration-resistant prostate cancer (mCRPC) after abiraterone treatment.
- The study randomizes patients to either mevrometostat plus enzalutamide or physician's choice of enzalutamide or docetaxel.
- The primary endpoint is radiographic progression-free survival (rPFS), with overall survival as a key secondary endpoint.
- The trial aims to determine if adding mevrometostat can overcome anti-androgen resistance in mCRPC patients.last yearPhase 3 Trials Target Advanced Prostate Cancer with Novel Therapies• A Phase 3 trial is underway to assess CAN-2409 immunotherapy combined with radiation for localized prostate cancer, aiming to improve disease-free survival.
• Johnson & Johnson's Akeega, combining niraparib and abiraterone, is being evaluated in the AMPLITUDE study for metastatic castration-sensitive prostate cancer with HRR mutations.
• Pfizer's mevrometostat, an EZH2 inhibitor, is under investigation in the MEVPRO-1 trial for metastatic castration-resistant prostate cancer after abiraterone treatment.last year