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Recruiting NCT06978400

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

Phase II Interventional Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy.
Who it may be relevant to
Registry conditions: Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed 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.

Interventions

  • Drug mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy
    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 outcome measures

  • Objective Response Rate [Time frame: assessed at 8 and 16 weeks]
Secondary outcome measures (3)
  • Progression-free survival [Time frame: assessed up to 24 months]
  • Time to objective response [Time frame: assessed up to 12 months]
  • Overall survival [Time frame: assessed up to 36 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • Blokhin's Russian Cancer Research Center — Moscow

Identifiers

NCT: NCT06978400 · 05202500303

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗