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.
Single group
mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy
DrugDabrafenib 150 mg twice orally daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks, Сalcium folinate 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks.
Objective Response Rate
From date of enrollment until the date of first documented objective response
Progression-free survival
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Time to objective response
Time from start of treatment to objective response to treatment
Overall survival
From the time of enrolment until the death from any cause
Duration of response
Calculated from achieving objective response to progression or death from any cause
Disease control rate
Percentage of patients who achieved a complete response, partial response or disease stabilisation
Incidence of adverse events
Proportion of patients with adverse events out of all patients (NCI CTCAE 5.0)
Incidence of adverse events grade 3-4
Proportion of patients with adverse events grade 3-4 out of all patients (NCI CTCAE 5.0)
Click on the lead sponsor to view all of their trials.
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
