A phase II study of rechallenge with encorafenib+binimetinib+cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer with prior treatment history of combination therapy including encorafenib+cetuximab. - TRIDENTE

Kotani Daisuke0 个研究点目标入组 21 人开始时间: 2022年1月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Unresectable adenocarcinoma of the colon or rectum (excluding appendiceal carcinoma and anal canal carcinoma) was diagnosed by histological examination
•2. Wild-type RAS and BRAF V600E mutation in tumor tissue
•3. Refractory or intolerant for the prior therapy by fluoropyrimidines (including oxaliplatin or irinotecan). In the case of positive microsatellite instability (MSI-H), refractory or intolerant for the prior therapy of anti-PD-1 antibody
•4. The best overall response (RECIST Guidelines ver. 1.1) was CR or PR for combination therapy including encorafenib and cetuximab
•5. One and more regimens of antineoplastic post-treatments following PD by imaging or clinical PD was confirmed within 4 weeks after the last dose of encorafenib
•6. Participating in or planning to participate in the GOZILA trial
•7. Measurable disease by RECIST guideline ver. 1.1
•8. ECOG PS 0 or 1
•9. Age on the date of consent >= 20 years old
•10. Possible to take drugs orally
•11. Adequate organ function confirmed by laboratory values measured within 14 days before enrollment
•12. Written consent obtained from the patient

•1. Patients have the following serious complications;
•a. Active double or more cancer
•b. Poorly controlled brain metastasis or leptomeningeal metastasis
•c. Active infections
•d. Ascites, pleural effusion or pericardial effusion requiring continuous drainage at the date of registration
•e. Uncontrolled diabetes mellitus or hypertension
•f. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (NYHA Class 3 or 4) within the previous 6 months from enrollment
•g. Patients with or at risk of previous or current retinal vein occlusion.
•h. Psychosis or psychiatric symptoms that make it difficult to participate in this study
•2. The following therapy before first protocol treatment;
•a. Extensive surgery within 4 weeks
•b. Enterostomy within 2 weeks
•c. Any antineoplastic treatment within 2 weeks
•3. Unrecovered adverse events from prior treatment
•4. History of serious allergy to encorafenib, binimetinib or cetuximab
•5. Severe lung disease
•6. Pregnant, lactating, positive pregnancy test, or unwilling to prevent pregnancy
•7. Gilbert syndrome or known UGT1A1*6/*6, UGT1A1*28/*28, UGT1A1*6/*28

发起方

Kotani Daisuke