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

NCT06978400 | Recruiting Phase 2 DMC

• 1 other identifier: 05202500303
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

metastatic colorectal cancer; BRAF V600E- mutated; first line; MSS; treatment

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

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

  assessed at 8 and 16 weeks

Secondary Outcomes (3)

• Progression-free survival

  assessed up to 24 months

• Time to objective response

  assessed up to 12 months

• Overall survival

  assessed up to 36 months

Other Outcomes (5)

• Duration of response

  assessed up to 12 months

• Disease control rate

  through study completion, an average of 1 year

• Incidence of adverse events

  through study completion, an average of 1 year

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead
• City Clinical Oncology Hospital No 1: collaborator
• Moscow City Oncology Hospital No. 62: collaborator
• The Loginov MCSC MHD: collaborator
• MMCC Kommunarka MHD: collaborator

Study Sites (1)

Blokhin's Russian Cancer Research Center

Moscow, 115193, Russia

RECRUITING

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms

Interventions

dabrafenib; Cetuximab; Panitumumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mikhail Fedyanin MD

  Blokhin's Russian Cancer Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikhail Fedyanin MD

CONTACT

+7 905 704-33-18; fedianinmu@mail.ru

Evgenia Kuzmina MD

CONTACT

+7 9824012681; kuz011@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Drug: Dabrafenib * Drug: Cetuximab * Drug: Рanitumumab * Drug: Oxaliplatin * Drug: Irinotecan * Drug: Leucovorin * Drug: 5-FU

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 18, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): July 10, 2028
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)