Tests dabrafenib with chemotherapy as first treatment for colorectal cancer
Tests dabrafenib with chemotherapy in adults with BRAF-mutated metastatic colorectal cancer.
Plain-language title generated from the registry record
Registry title: A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer
Key facts
- Where
- Moscow, RussiaSee the site
- Phase
- Phase 2
Where in Russia
- Blokhin's Russian Cancer Research CenterMoscow, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Blokhin's Russian Cancer Research Center
- Trial code
- NCT06978400
- Record updated
- 18 May 2025
- Original description
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.Read full original descriptionShow less
Non-randomised, Multicentre, Prospective, Single-arm, Phase II Study of the Efficacy and Toxicity of a Combination of FOLFOX With Dabrafenib and Cetuximab/Panitumumab in the First Line of Therapy of Patients With Metastatic BRAF V600E- Mutated MSS Colorectal Cancer
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.
Inclusion: 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.
Exclusion: Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment; 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); HIV-infected patients; The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial; Pregnant and breastfeeding women; Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study; Patients with a life expectancy of less than 3 months.