临床试验/NCT04486378

NCT04486378

招募中

2 期

A Multi-site, Open-label, Phase II, Randomized, Controlled Trial to Compare the Efficacy of RO7198457 Versus Watchful Waiting in Resected, Stage II (High Risk) and Stage III Colorectal Cancer Patients Who Are ctDNA Positive Following Resection

BioNTech SE197 个研究点分布在 5 个国家目标入组 327 人2021年3月8日

适应症Colorectal Cancer Stage II Colorectal Cancer Stage III

干预措施RO7198457 intravenous (IV)Observational group (no intervention)

概览

阶段: 2 期
干预措施: RO7198457 intravenous (IV)
疾病 / 适应症: Colorectal Cancer Stage II
发起方: BioNTech SE
入组人数: 327
试验地点: 197
主要终点: Disease-free survival (DFS)
状态: 招募中
最后更新: 17天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

概览

简要总结

This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.

详细描述

Patients will receive up to 15 doses of RO7198457 over the course of trial treatment.

注册库

clinicaltrials.gov

开始日期

2021年3月8日

结束日期

2030年8月1日

最后更新

17天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

BioNTech SE

责任方

Sponsor

入排标准

入选标准

•Patients must be a man or woman of at least 18 years of age.
•Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per American Joint Committee on Cancer (AJCC) 2017 that has been surgically totally resected (R0 confirmed by pathology report). Stage II (high risk) colon cancer is defined as Stage II disease with any of the following risk factors for recurrence:
•Clinical presentation with bowel obstruction or perforation.
•Histological signs of vascular, lymphatic or perineural invasion.
•\< 12 nodes evaluated after surgery.
•For the CLM Cohort: patients must have metastatic colorectal cancer (mCRC) (Stage IV) with resected CLM (synchronous and metachronous CLM within 6 months of initial diagnosis) per AJCC 2017, after standard of care (SoC) primary resection and curative-intent hepatectomy (R0 confirmed by pathology report) with or without (neo-)adjuvant chemotherapy (prior to hepatectomy), and planned adjuvant chemotherapy.
•For the Biomarker Cohort: patients with tumors of the colon, including but not limited to, colon adenocarcinoma, carcinoid tumors (including goblet cell carcinoid/adenocarcinoma), and tumors of the appendix, whose tumors were surgically resected and are planned for adjuvant chemotherapy (per institutional standards), can be included.
•Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx) (except for the Biomarker Cohort).
•ctDNA assay must be performed through this trial or study BNT000-001 ctDNA screening protocol.
•Patients must have an Eastern Cooperative Oncology Group Performance Status of 0-

排除标准

•Patients with uncontrolled intercurrent illness as defined by the protocol.
•Diagnosed microsatellite instability high tumors.
•Prior therapy with any of the following:
•Neo-adjuvant (radio)chemotherapy prior to surgery.
•Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of trial treatment or anticipation of need for systemic immunosuppressive medication during trial treatment, with the exception of low dose steroids defined as 10 mg oral prednisone (or equivalent).
•Current or recent (within the 28 days prior to randomization) treatment with another investigational drug.
•Exception for the CLM Cohort: primary tumor must be resected and (neo-)adjuvant chemotherapy prior to curative-intent hepatectomy is accepted.
•Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
•Patients who developed metastatic disease during screening/receiving standard of care treatment (not applicable for the Exploratory Cohort or the Biomarker Cohort).
•Patients with known past or current malignancy other than inclusion diagnosis, except for:

研究组 & 干预措施

RO7198457

Participants will receive a recommended dose of RO7198457.

干预措施: RO7198457 intravenous (IV)

Observational Group

Observational group will undergo watchful waiting, which is the standard of care in this setting.

干预措施: Observational group (no intervention)

Biomarker Cohort

干预措施: RO7198457 intravenous (IV)

Exploratory Cohort

干预措施: RO7198457 intravenous (IV)

Colorectal Liver Metastasis (CLM) Cohort

干预措施: RO7198457 intravenous (IV)

结局指标

主要结局

Disease-free survival (DFS)

时间窗: Through study completion, up to 5 years

DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first: * Locoregional recurrence or distant metastases as determined by an independent central radiology assessment. * Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment. * Death from any cause. * Loss to follow-up is censored.

次要结局

Change of ctDNA status (approximately every 3 months)(Through study completion, up to 5 years)
Relapse-free survival (RFS)(Through study completion, up to 5 years)
Time to recurrence (TTR)(Through study completion, up to 5 years)
Time to treatment failure (TTF)(Through study completion, up to 5 years)
Overall survival (OS)(Through study completion, up to 5 years)
Occurrence of treatment emergent adverse event (TEAE)(15 months)
Occurrence of dose reduction and discontinuation of RO7198457 due to a TEAE.(15 months)