The purpose of this study is to evaluate the efficacy and toxicity of FOLFOX regimen with dabrafenib and cetuximab/panitumumab in the first line of therapy for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene and MSS.
Participants in this study will receive one of the following study treatments:
These participants will receive FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy This study is currently enrolling participants who will receive either FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy.
The study team will monitor how each participant responds to the study treatment for up to about 3 years.
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).
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.
Blokhin's Russian Cancer Research Center
Lead sponsor
City Clinical Oncology Hospital No 1
Collaborator
Moscow City Oncology Hospital No. 62
Collaborator
The Loginov MCSC MHD
Collaborator
Moscow Multidisciplinary Clinical Center "Kommunarka"
Collaborator