NCT06967155

A Study of Irinotecan With Dabrafenib Plus Trametinib and Anti-EGFR in the Second Line of Therapy in People With Metastatic Colorectal Cancer

Non-randomised, Multicentre, Prospective, Single-arm, Phase II Study of the Efficacy and Toxicity of a Combination of Irinotecan With Dabrafenib and Trametinib, Anti-EGFR in the Second Line of Treatment of Patients With Metastatic BRAF V600E- Mutated Colorectal Cancer.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy and toxicity of irinotecan with dabrafenib, cetuximab/panitumumab in the second line of treatment for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene. Participants in this study will receive one of the following study treatments: These participants will receive in the second line is irinotecan, dabrafenib + trametinib, cetuximab or panitumumab. This trial is currently enrolling participants who will receive either irinotecan and dabrafenib plus cetuximab or panitumumab in the second 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 irinotecan in combination with dabrafenib + trametinib and cetuximab or panitumumab in second-line treatment of patients with metastatic inoperable colorectal cancer who have a BRAF mutation.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	• Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU	Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy Dabrafenib 150 mg twice orally daily Trametinib 2 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Irinotecan 90 mg/m2 (90-minute IV infusion) weekly. Second-line treatment is administered until disease progression or intolerable toxicity. It may be possible to switch to a regimen of dabrafenib, trametinib, cetuximab or panitumumab if irinotecan is intolerable.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-11-10
• Completion: 2028-06-10
• First posted: 2025-05-13
• Last updated: 2025-10-02

Locations

1 site across 1 country: Russia