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

Sponsor
Blokhin's Russian Cancer Research Center
Study ID
NCT06967155
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Sep 2025
Primary completion
Nov 10, 2027
Completion
Jun 10, 2028

Study Design

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

Arms

  • Experimental: Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy
    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.

Primary Outcome Measure

Objective Response Rate [ Time Frame: assessed up to 12 months ]

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