Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab
研究概览
简要总结
This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.
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
- •History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs
- •Patient must have had 1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide.
- •Patients must decline or be ineligible for taxane therapy in the opinion of the treating physician.
- •All patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and/or carotuximab)
排除标准
- •Non-PSA producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without PSA rise
- •Prior use of apalutamide
- •Other prior malignancy requiring active anticancer therapy
- •Prior exposure to carotuximab or any CD105 targeted antibody
- •Active bleeding or pathologic medical conditions that carries a high bleeding risk
- •A known diagnosis of Osler-Weber-Rendu syndrome
研究组 & 干预措施
Apalutamide monotherapy
After progression, subjects will crossover to combination therapy
干预措施: Apalutamide (Drug)
Combination therapy (Apalutamide + Carotuximab)
干预措施: Apalutamide (Drug)
Combination therapy (Apalutamide + Carotuximab)
干预措施: Carotuximab (Drug)
结局指标
主要结局
Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab
时间窗: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.
From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause.
次要结局
- Overall radiographic response rate (ORR) in the overall population(From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.)
- To determine the biochemical PFS (by PCWG3) in the overall population(From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.)
- Overall radiographic response rate (ORR) of the combination of apalutamide + carotuximab(From the start of combination study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.)
- Proportion of patients resistant to apalutamide benefit from the addition of carotuximab(From the start of combination therapy study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.)
- To determine the radiographic progression free survival (rPFS) in the overall population(From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.)
- Incidence of Adverse events (grade 3 or higher) related to carotuximab and apalutamide(From start of study treatment through 4 weeks on treatment)
研究者
Edwin Posadas, MD
Co-Director, Experimental Therapeutics Program
Cedars-Sinai Medical Center