Avelumab added to FOLFIRI plus Cetuximab followed by Avelumab maintenance in patients with previously untreated RAS/BRAF wild-type metastatic colorectal cancer - The phase II FIRE-6-Avelumab study - AIO KRK-0118/FIRE-6

Klinikum der Ludwig-Maximilians-Universität München - Klinikum Großhadern (vertreten durch den kaufmännischen Direktor)0 个研究点目标入组 55 人2019年1月2日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Avelumab added to FOLFIRI plus cetuximab followed by avelumab maintenance in patients with previously untreated RAS/BRAF wild-type metastatic colorectal cancer - the phase II FIRE-6-avelumab study
发起方: Klinikum der Ludwig-Maximilians-Universität München - Klinikum Großhadern (vertreten durch den kaufmännischen Direktor)
入组人数: 55
状态: 进行中（未招募）
最后更新: 4年前

暂无简介。

注册库

who.int

开始日期

2019年1月2日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Klinikum der Ludwig-Maximilians-Universität München - Klinikum Großhadern (vertreten durch den kaufmännischen Direktor)

•1\. Histologically confirmed, UICC stage IV adenocarcinoma of the colon or rectum with metastases (mCRC), metastases primarily non resectable
•or surgery refused by the patient
•2\. RAS wild\-type tumour status (KRAS and NRAS, exon 2, 3, 4\) and BRAF wild\-type tumour status (V600, exon 15\) (proven in the primary
•tumour or metastasis)
•3\. Adult patients \= 18 years
•4\. ECOG performance status 0\-1
•5\. Patients suitable for chemotherapy administration
•6\. Patient's written declaration of consent obtained
•7\. Estimated life expectancy \> 3 months
•8\. Presence of at least one measurable reference lesion according to the RECIST v1\.1 criteria

•1\. Proof of a RAS mutation (KRAS or NRAS, exons 2, 3, 4\) or BRAF mutation (V600 in exon 15\) in the tumour (proven in primary tumour
•or metastasis) or absence of testing for RAS or BRAF mutations
•2\. Primarily resect metastases and the patient wishes for resection
•3\. \= Grade II heart failure (NYHA classif)
•4\. Myocardial infarct, balloon angioplasty (PTCA) with or without stenting \+ cerebral vascular accident/stroke within the past 12 months before start of study treatm, unstable angina pectoris, serious cardiac arrhythmia according to investigator’s judgem. requiring medic.
•5\. Pre\-existing pulmonary fibrosis or immune pneumonitis
•6\. Active autoimmune disease that might be negatively affected by an immune checkpoint inhibitor. Patients diabetes type I, vitiligo, psoriasis, or hypo\- or hyperthyroid diseases not requiring immunosup. treatment are eligible.
•7\. Prior organ transpl., incl allogeneic stem cell transpl.
•8\. Current use of immunosuppressive medi, except for the following:
•a) Intranasal, inhaled, topical steroids, or local steroid inject (e.g., intra\-articular inject);