A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 153
- 主要终点
- Radiographic Progression-Free Survival (rPFS) by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans or death due to any cause) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Have histologically confirmed adenocarcinoma of the prostate
- •Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m^Tc bone scan as determined by the investigator
- •Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) (<= 1.73 nanomoles per Liter [nmol/L]) at screening
- •Have progressed by PSA or CT/MRI or 99m^Tc bone scan on at least 1 novel androgen receptor pathway inhibition (ARPI) but no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study
- •Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
排除标准
- •Known history of either brain or leptomeningeal prostate cancer metastases
- •Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated
- •Prior or concurrent second malignancy (other than the disease under study)
- •Received cytotoxic chemotherapy for prostate cancer in any setting
- •Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
研究组 & 干预措施
Docetaxel
Participants will receive docetaxel along with prednisone/prednisolone as background medication.
干预措施: Prednisone/Prednisolone (Drug)
Pasritamig+Docetaxel
Participants will receive pasritamig along with docetaxel until the end of treatment (EOT) visit or until radiographic disease progression is confirmed by blinded independent central review (BICR), or any other protocol defined criteria are met.
干预措施: Docetaxel (Drug)
Pasritamig+Docetaxel
Participants will receive pasritamig along with docetaxel until the end of treatment (EOT) visit or until radiographic disease progression is confirmed by blinded independent central review (BICR), or any other protocol defined criteria are met.
干预措施: Pasritamig (Drug)
Docetaxel
Participants will receive docetaxel along with prednisone/prednisolone as background medication.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Radiographic Progression-Free Survival (rPFS) by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan Assessed by Blinded Independent Central Review (BICR)
时间窗: Up to approximately 1 years 10 months
rPFS by CT/MRI or bone scan is assessed by BICR and is defined as the time from the date of randomization to the first date of radiographic disease progression, or death due to any cause, whichever occurs first.
Radiographic Progression-Free Survival (rPFS) Assessed by BICR
时间窗: Up to approximately 1 years 10 months
rPFS is assessed by BICR and is defined as the time from the date of randomization to the first date of radiographic disease progression, or death due to any cause, whichever occurs first.
次要结局
- Treatment Side Effect as Assessed by EORTC IL46 Score(Up to approximately 4 years 5 months)
- Time to Symptomatic Progression (TSP)(Up to approximately 4 years 5 months)
- Time to Subsequent Therapy (TST)(Up to approximately 4 years 5 months)
- Time to Skeletal-Related Event (TSRE)(Up to approximately 4 years 5 months)
- Time to Symptomatic Progression (TSP)(Up to approximately 4 years 5 months)
- Time to Subsequent Therapy (TST)(Up to approximately 4 years 5 months)
- Time to Skeletal-Related Event (TSRE)(Up to approximately 4 years 5 months)
- Overall Survival (OS)(Up to approximately 4 years 5 months)
- Objective Response Rate (ORR)(Up to approximately 4 years 5 months)
- Duration of Response (DOR)(Up to approximately 4 years 5 months)
- Duration of PSA Response(Baseline and up to approximately 4 years 5 months)
- Time to Prostate-Specific Antigen (PSA) Progression(Up to approximately 4 years 5 months)
- Proportion of Participants Who Achieved Prostate-Specific Antigen (PSA) 50 Response(Up to approximately 4 years 5 months)
- Proportion of Participants Who Achieved Prostate-Specific Antigen (PSA) 90 Response(Up to approximately 4 years 5 months)
- Progression Free Survival After Subsequent Therapy (PFS2)(Up to approximately 4 years 5 months)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity(Up to approximately 4 years 5 months)
- Number of Participants With Clinical Laboratory Abnormalities(Up to approximately 4 years 5 months)
- Change from Baseline in HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cancer Module (EORTC QLQ-C30) Scale Score(Baseline up to approximately 4 years 5 months)
- Change from Baseline in Health Related Quality of Life (HRQoL) as Assessed by Brief Pain Inventory-Short Form (BPI-SF)(Baseline up to approximately 4 years 5 months)
- Change from Baseline in HRQoL as Assessed by EORTC Quality of Life Questionnaire-Prostate (EORTC QLQ-PR25) Scale Score(Baseline up to approximately 4 years 5 months)
- Change from Baseline in HRQoL as Assessed by European Quality of Life Visual Analog Scale (EQ-5D VAS) Score(Baseline up to approximately 4 years 5 months)
- Time to Sustained Worsening of Pain as Assessed by BPI-SF(Up to approximately 4 years 5 months)
- Treatment Side Effect as Assessed by EORTC IL-6 Score(Up to approximately 4 years 5 months)
- European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Scale Score(Up to approximately 4 years 5 months)