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

Sponsor
Blokhin's Russian Cancer Research Center
Study ID
NCT06978400
Phase
PHASE2
Status
Recruiting
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Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
May 2025
Primary completion
Nov 10, 2027
Completion
Jul 10, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Objective Response Rate [ Time Frame: assessed at 8 and 16 weeks ]

Central Contacts

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