CAVE (Cetuximab-AVElumab) mCRC: A single arm phase IIclinical study of the combination of avelumab plus cetuximab in pre-treated RAS wild type metastatic colorectal cancer patients. - CAVE mCRC

A.O.U. Università degli Studi della Campania Luigi Vanvitelli0 个研究点目标入组 75 人开始时间: 2020年10月5日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•Histologically proven diagnosis of colorectal adenocarcinoma;
•Diagnosis of metastatic disease;
•RAS (NRAS and KRAS exon 2,3 and 4) wild-type in tissue at initial diagnosis;
•Efficacy of a first line therapy containing an anti-EGFR agent (panitumumab or cetuximab) with a major response achieved (complete or partial response);
•A second line therapy;
•More than 4 months from last dose of anti-EGFR agent administered in first line treatment before randomization;
•Measurable disease according to RECIST criteria v1.1;
•ECOG PS of 0 to 1 at trial entry;
•Estimated life expectancy of more than 12 weeks.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 37
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 38

•Participation in a clinical study or experimental drug treatment within 30 days;
•Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment;
•All subjects with brain metastases, except those meeting the following criteria:
•-Brain metastases have been treated locally, and
•-No ongoing neurological symptoms that are related to the brain localization of the disease;
•Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.

发起方

A.O.U. Università degli Studi della Campania Luigi Vanvitelli