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

NCT ID: NCT06978400

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2028-07-10

Brief 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.

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

In the first-line setting, 8 courses are administered, and if disease control is achieved, dabrafenib, cetuximab or panitumumab therapy is continued until disease progression or intolerable toxicity.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

City Clinical Oncology Hospital No 1

OTHER_GOV

Sponsor Role: collaborator

Moscow City Oncology Hospital No. 62

OTHER_GOV

Sponsor Role: collaborator

The Loginov MCSC MHD

UNKNOWN

Sponsor Role: collaborator

MMCC Kommunarka MHD

UNKNOWN

Sponsor Role: collaborator

Blokhin's Russian Cancer Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikhail Fedyanin MD

Role: PRINCIPAL_INVESTIGATOR

Blokhin's Russian Cancer Research Center

Locations

Blokhin's Russian Cancer Research Center

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Mikhail Fedyanin MD

Role: CONTACT

fedianinmu@mail.ru

+7 905 704-33-18

Evgenia Kuzmina MD

Role: CONTACT

kuz011@mail.ru

+7 9824012681

Facility Contacts

Evgenia Kuzmina

Role: primary

kuz011@mail.ru

89824012681

Mikhail Fedyanin MD

Role: backup

fedianinmu@mail.ru

+7 905 704-33-18

Other Identifiers

05202500303

Identifier Type: -

Identifier Source: org_study_id