NIPH Clinical Trials Search

JRCT ID: jRCTs031210510

Registered date:01/01/2022

Addition of binimetinib after refractory to encorafenib and cetuximab in patients with BRAF V600E-mutant metasta tic colorectal cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUnresectable, advanced or recurrent colorectal cancer with BRAF V600E mutation
Date of first enrollment24/02/2022
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Encorafenib 300 mg once daily Binimetinib 45 mg twice daily Cetuximab 400 mg/m^2 Day 1, 250 mg/m^2 Day 8, 15, 22 (250 mg/m^2 from Cycle 2 later) These treatments are repeated every 28 days in one cycle.


Primary OutcomeProgression-free survival rate at 12 weeks after first protocol treatment
Secondary OutcomeProgression-free survival (PFS) Objective response rate (ORR) Disease control rate (DCR) Time to treatment failure (TTF) Overall survival (OS) Rate of adverse events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1. 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. The best overall response (RECIST Guidelines ver 1.1) was CR, PR, SD (>= 4 months), nonCR/nonPD (>= 4 months) for combination therapy including encorafenib and cetuximab 4. PD by imaging or clinical PD was confirmed within 4 weeks after the last dose of encolafenib 5. No history of MEK inhibitor administration 6. Participating in or planning to participate in the GOZILA trial 7. ECOG PS 0 or 1 8. Age on the date of consent >= 20 years old 9.Possible to take drugs orally 10.Applicable starting doses of encorafenib, binimetinib, and cetuximab as defined in this trial 11. Adequate organ function confirmed by laboratory values measured within 14 days before enrollment 12.Written consent obtained from the patient
Exclude criteria1. 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(Encolafenib, cetuximab, and 5-FU are acceptable) 3. Unrecovered adverse events from prior treatment 4. History of serious allergy to encorafenib 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

Related Information


Public contact
Name Hideaki Bando
Address 6-5-1 Kashiwanoha, Kashiwa-shi Chiba Chiba Japan 277-8577
Telephone +81-4-7133-1111
Affiliation National Cancer Center Hospital East
Scientific contact
Name Hideaki Bando
Address 6-5-1 Kashiwanoha, Kashiwa-shi Chiba Chiba Japan 277-8577
Telephone +81-4-7133-1111
Affiliation National Cancer Center Hospital East