A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer

Last updated: May 11, 2025
Sponsor: Blokhin's Russian Cancer Research Center
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Treatment

mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy

Clinical Study ID

NCT06978400
05202500303
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600Emutation

  • Metastatic inoperable colorectal cancer

  • Adequate function of hematopoiesis and basic indicators of internal organs

  • Has measurable or evaluable disease according to Response Evaluation Criteria InSolid Tumors (RECIST v1.1).

  • Lacking antitumor systemic treatment for colorectal cancer.

  • Patients with progression after adjuvant chemotherapy may be included if progressionis 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

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 withoxaliplatin 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 useadequate 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.

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy
Phase: 2
Study Start date:
March 01, 2025
Estimated Completion Date:
July 10, 2028

Study Description

The purpose of the study is to evaluate the efficacy and toxicity of first-line FOLFOX with dabrafenib and cetuximab or panitumumab in patients with previously untreated metastatic inoperable colorectal cancer who have MSS and BRAF mutation.

Connect with a study center

  • Blokhin's Russian Cancer Research Center

    Moscow, 115193
    Russian Federation

    Active - Recruiting

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