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NCT Number: NCT06978400

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

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Key information

Conditions

Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Dabrafenib 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.

Primary outcomes

  1. Objective Response Rate

    Time frame: assessed at 8 and 16 weeks

    From date of enrollment until the date of first documented objective response

Secondary outcomes

  1. Progression-free survival

    Time frame: assessed up to 24 months

    From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first

  2. Time to objective response

    Time frame: assessed up to 12 months

    Time from start of treatment to objective response to treatment

  3. Overall survival

    Time frame: assessed up to 36 months

    From the time of enrolment until the death from any cause

Other outcomes

  1. Duration of response

    Time frame: assessed up to 12 months

    Calculated from achieving objective response to progression or death from any cause

  2. Disease control rate

    Time frame: through study completion, an average of 1 year

    Percentage of patients who achieved a complete response, partial response or disease stabilisation

  3. Incidence of adverse events

    Time frame: through study completion, an average of 1 year

    Proportion of patients with adverse events out of all patients (NCI CTCAE 5.0)

  4. Incidence of adverse events grade 3-4

    Time frame: through study completion, an average of 1 year

    Proportion of patients with adverse events grade 3-4 out of all patients (NCI CTCAE 5.0)

  5. Frequency of dose reductions and drug withdrawals

    Time frame: through study completion, an average of 1 year

    Proportion of patients with dose reductions and drug withdrawals in the total number of patients

Study contacts

Contact information is provided by the study sponsor or research team.

Evgenia Kuzmina MD

CONTACT

[email protected]

+7 9824012681

Mikhail Fedyanin MD

CONTACT

[email protected]

+7 905 704-33-18

Sponsors and collaborators

Lead sponsor

Blokhin's Russian Cancer Research Center

Other

Collaborators

  • City Clinical Oncology Hospital No 1
  • Moscow City Oncology Hospital No. 62
  • Moscow Multidisciplinary Clinical Center "Kommunarka"
  • The Loginov MCSC MHD

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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