A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,297
- 试验地点
- 219
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
详细描述
BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls.
Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are:
- (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF
- (Arm V) PROSTVAC-V/F plus GM-CSF placebo
- (Arm P) Double placebo
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
- •Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
- •Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer.
- •PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).
- •Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated).
排除标准
- •Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed).
- •Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo.
- •Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F.
- •History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin.
- •Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
- •History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.
研究组 & 干预措施
PROSTVAC-V/F-TRICOM + GM-CSF
- PROSTVAC-V-TRICOM
- PROSTVAC-F-TRICOM
- GM-CSF
干预措施: PROSTVAC-V (Biological)
PROSTVAC-V/F-TRICOM + GM-CSF
- PROSTVAC-V-TRICOM
- PROSTVAC-F-TRICOM
- GM-CSF
干预措施: PROSTVAC-F (Biological)
PROSTVAC-V/F-TRICOM + GM-CSF
- PROSTVAC-V-TRICOM
- PROSTVAC-F-TRICOM
- GM-CSF
干预措施: GM-CSF (Drug)
PROSTVAC-V/F-TRICOM + GM-CSF placebo
- PROSTVAC-V-TRICOM
- PROSTVAC-F-TRICOM
- GM-CSF placebo
干预措施: PROSTVAC-V (Biological)
PROSTVAC-V/F-TRICOM + GM-CSF placebo
- PROSTVAC-V-TRICOM
- PROSTVAC-F-TRICOM
- GM-CSF placebo
干预措施: PROSTVAC-F (Biological)
PROSTVAC-V/F-TRICOM + GM-CSF placebo
- PROSTVAC-V-TRICOM
- PROSTVAC-F-TRICOM
- GM-CSF placebo
干预措施: GM-CSF Placebo (Other)
Placebo Control
PROSTVAC V/F Placebo + GM-CSF Placebo
干预措施: GM-CSF Placebo (Other)
Placebo Control
PROSTVAC V/F Placebo + GM-CSF Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Overall Survival
时间窗: Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study.
The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.
次要结局
- Number of Subjects Alive Without Event at 6 Months(Randomization through Week 25/End of Treatment visit.)