Combining Dabrafenib with FOLFOX and Cetuximab/Panitumumab for Metastatic Colorectal Cancer
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
This study is testing if a new combination of chemotherapy and targeted treatments can help people with metastatic colorectal cancer that has a specific mutation feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Blokhin's Russian Cancer Research Center Academic / other |
| Drugs / interventions | chemotherapy, cetuximab, panitumumab |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06978400 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with untreated metastatic colorectal cancer that has a BRAF V600E mutation and is microsatellite stable.
Not a fit: Patients who have received more than two lines of treatment or have other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with a specific type of metastatic colorectal cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and chemotherapy in treating colorectal cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Moscow
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.