Phase II RAINSPOT: a multicentric open label trial of Zolbetuximab-Paclitaxel-Ramucirumab in second line setting for CLDN18.2 positive gastro-esophageal adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- The primary endpoint is OS (overall survival), which is defined as the time from the date of signature of informed consent until death from any cause. Patients starting a subsequent line of treatment after study discontinuation will not be censored for survival at the start of this subsequent treatment. Subjects who are still alive at the time of analysis will be censored at the last day known to be alive.
研究概览
简要总结
To evaluate the effect of the addition of Zolbetuximab to standard treatment on survival in CLDN18.2 positive patients that were previously treated in first line but unexposed to Zolbetuximab or other anti CLDN18.2 targeted therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- •WHO performance status 0 - 1
- •Histologically proven metastatic gastroesophageal adenocarcinoma
- •Pretreatment with one 1st line therapy according to SOC (+/- immunotherapy)
- •If relapse while adjuvant (immune/chemo) therapy or within 6 months ending adjuvant therapy the adjuvant therapy is considered a first line therapy
- •CLDN18.2-positive (defined as ≥75% of tumour cells showing moderate-to-strong membranous CLDN18.2 staining, as determined by immunohistochemistry using the VENTANA CLDN18 [43-14A] RxDx Assay.
- •Any PDL1 score
- •Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
排除标准
- •Metastatic squamous cell cancer of the esophagus
- •Absolute contra-indication for anti-VEGF inhibitors (tumour perforation, active proteinuria, recent stroke, myocardial infarction, acute arterial thrombosis, active wound problem)
- •Other active malignancy
- •Pretreatment with Zolbetuximab or other anti-CLDN18.2 direct therapy in first line setting once available
- •Known hypersensitivity to the active substance Zolbetuximab or to any of the excipients [(Arginine, Phosphoric acid (E 338), Sucrose, Polysorbate 80 (E 433)]
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
- •Participation in another interventional Trial with an investigational medicinal product (IMP) or device
结局指标
主要结局
The primary endpoint is OS (overall survival), which is defined as the time from the date of signature of informed consent until death from any cause. Patients starting a subsequent line of treatment after study discontinuation will not be censored for survival at the start of this subsequent treatment. Subjects who are still alive at the time of analysis will be censored at the last day known to be alive.
The primary endpoint is OS (overall survival), which is defined as the time from the date of signature of informed consent until death from any cause. Patients starting a subsequent line of treatment after study discontinuation will not be censored for survival at the start of this subsequent treatment. Subjects who are still alive at the time of analysis will be censored at the last day known to be alive.
次要结局
- Secondary Endpoints PFS, which is defined as the time from the date of signature of informed consent until the date of radiological PD (per Response Evaluation Criteria in Solid Tumours [RECIST] 1.1) or death from any cause, whichever is earliest. Patients unprogressed at time of discontinuation for other causes, starting a subsequent line of treatment will be censored for progression at the start of this subsequent treatment.
- Safety will be assessed and reported continuously as per regulations.
研究者
Filip Van Herpe
Scientific
UZ Leuven