Combining Dabrafenib with FOLFOX and Cetuximab/Panitumumab for Metastatic Colorectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of the FOLFOX chemotherapy regimen combined with dabrafenib and either cetuximab or panitumumab as a first-line treatment for patients with metastatic colorectal cancer that has a BRAF V600E mutation and is microsatellite stable (MSS). Participants will receive these treatments and be monitored for their response over a period of up to three years. The goal is to determine how well this combination works compared to standard treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Blokhin's Russian Cancer Research Center
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Mikhail Fedyanin MD — Blokhin's Russian Cancer Research Center
• Study coordinator: Mikhail Fedyanin MD
• Email: fedianinmu@mail.ru
• Phone: +7 905 704-33-18

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.