Moscow Multidisciplinary Clinical Center "Kommunarka"
The purpose of the study is to evaluate the efficacy and toxicity of first-line FOLFOX with dabrafenib and cetuximab or panitumumab in patients with previously untreated metastatic inoperable colorectal cancer who have MSS and BRAF mutation.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation
Metastatic inoperable colorectal cancer
Adequate function of hematopoiesis and basic indicators of internal organs
Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Lacking antitumor systemic treatment for colorectal cancer.
Patients with progression after adjuvant chemotherapy may be included if progression is recorded no earlier than 12 months after the last course of chemotherapy.
The primary tumor is removed or asymptomatic.
Absence of grade 2 or higher neuropathy.
Absence of tumor MSI or dMMR.
ECOG PS 0-2
You may not be if
Participants having more than 2 lines of treatment (a progression of disease within 12 months of the completion of adjuvant and/or perioperative chemotherapy with oxaliplatin and fluoropyrimidines is acceptable).
Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment.
Pregnant and breastfeeding women.
Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study.
HIV-infected patients.
Patients with a life expectancy of less than 3 months.
The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial.
Clareo Health | A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer
