2022-500027-76-00招募中2 期
METIMMOX-2: Metastatic pMMR/MSS Colorectal Cancer – Shaping Anti-Tumor Immunity by Oxaliplatin
Akershus University Hospital6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- PFS: radiologic assessment following every 2 cycles each of FLOX and nivolumab, according to RECIST v1.1 and iRECIST
研究概览
简要总结
To determine progression-free survival (PFS) of repeat sequential treatment with oxaliplatin-based chemotherapy (the Nordic FLOX regimen) and an immune checkpoint inhibitor (nivolumab) in previously untreated unresectable metastatic pMMR/MSS colorectal cancer (CRC).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patient has histologically verified CRC adenocarcinoma.
- •Patient has radiologically measurable metastatic disease.
- •Patient has not had previous systemic cytotoxic therapy for the metastatic disease, except for previous neoadjuvant treatment.
- •Patient is eligible for the Nordic FLOX chemotherapy regimen.
排除标准
- •Patient has initially resectable metastatic disease for which systemic therapy is deemed superfluous.
- •Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or worse.
- •Patient has serum/plasma C-reactive protein (CRP) of 60 mg/L or higher.
- •Patient does not meet the following requirements at baseline: adequate bone marrow function without current use of colony-stimulating factors (minimum values of neutrophils 1.5 x10e9/L, platelets 100 x10e9/L, hemoglobin 10 g/dL), adequate liver function (maximum values of AST/ALT 5 xULN and bilirubin 2 xULN; albumin value of 30 g/L or higher; INR within normal level), adequate renal function (maximum creatinine value of 1.5 xULN), protein in urine less than 2+ by dipstick (within 14 days prior to initiation of study treatment).
- •Patient has any other reason, in the opinion of Clinical Investigator, not to participate in the study.
- •Patient does not present any infradiaphragmatic metastatic manifestation.
- •Patient has untreated or symptomatic brain metastasis (patient must be symptom-free without the use of corticosteroids).
- •Patient experiences a period of less than 6 months since discontinuation of neoadjuvant or adjuvant oxaliplatin-containing chemotherapy.
- •Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle.
- •Patient has had radiation therapy against the only measurable lesion within 4 weeks of start of study treatment.
- •Patient has a nervous system disorder worse than grade 1 of the Common Terminology Criteria for Adverse Events (CTCAE) v5.
- •Patient has any medical condition or has undergone any treatment within 4 weeks of start of study treatment that will preclude him/her from cancer immune therapy.
- •Patient has any medical condition that will preclude him/her from receiving a component of the FLOX regimen.
结局指标
主要结局
PFS: radiologic assessment following every 2 cycles each of FLOX and nivolumab, according to RECIST v1.1 and iRECIST
PFS: radiologic assessment following every 2 cycles each of FLOX and nivolumab, according to RECIST v1.1 and iRECIST
次要结局
- Safety: incidence of adverse events, as reported according to CTCAE v5.0, recorded on onboing basis and summarized at every visit.
- Tolerability: adverse event grading, as assessed by CTCAE v5.0, recorded on onboing basis and summarized at every visit.
- Objective response rate: the percentage of patients with a confirmed complete or partial response.
- Duration of response: the time from the first documentation of a complete or partial response to disease progression on active therapy.
- Secondary surgical curative-intent resection rate: the percentage of patients with a confirmed resection of metastatic disease with microscopically free margin (R0).
- Overall survival: the time from study enrollment to death of any cause.
研究者
Anne Hansen Ree
Scientific
Akershus University Hospital
研究点 (6)
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