A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 760
- 试验地点
- 178
- 主要终点
- Recurrence free survival (RFS) for Arm A vs. Arm B
研究概览
简要总结
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
详细描述
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.
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)
盲法说明
Double-blind masking
入排标准
- 年龄范围
- 18 Years 至 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)
- •Provision of a tumor sample collected at surgical resection.
- •Randomization within 12 weeks after resection with adequate healing and removal of drains.
- •Confirmed to be disease-free by imaging within 28 days prior to randomization.
- •Eastern Cooperative Oncology Group performance status of 0 or 1
排除标准
- •Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
- •Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
- •Any anti-cancer therapy for BTC prior to surgery
- •Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
- •Current or prior use of immunosuppressive medication within 14 days before the first dose
- •Thromboembolic event within 3 months
- •Active HBV or HCV infection unless treated.
研究组 & 干预措施
Arm A
Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
干预措施: Rilvegostomig (Drug)
Arm A
Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
干预措施: Capecitabine (Drug)
Arm A
Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
干预措施: Gemcitabine/Cisplatin (Drug)
Arm B
Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
干预措施: Gemcitabine/Cisplatin (Drug)
Arm A
Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
干预措施: S-1 [Tegafur/Oteracil/gimeracil] (Drug)
Arm B
Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
干预措施: S-1 [Tegafur/Oteracil/gimeracil] (Drug)
Arm B
Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
干预措施: Placebo (Drug)
Arm B
Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
干预措施: Capecitabine (Drug)
结局指标
主要结局
Recurrence free survival (RFS) for Arm A vs. Arm B
时间窗: Approximately 5 years
Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first.
次要结局
- Overall Survival (OS) for Arm A vs. Arm B(up to 7 years)
研究者
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB