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

NCT06967155 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 05202500302
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms

Keywords

metastatic colorectal cancer; BRAF V600E- mutated; treatment

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  From date of enrollment until the date of first documented progression

  assessed up to 12 months

Secondary Outcomes (8)

• Progression-free survival

  assessed up to 24 months

• Time to objective response

  assessed up to 6 months

• Duration of response

  assessed up to 12 months

• Disease control rate

  Percentage of patients who achieved a complete response, partial response or disease stabilisation? through study completion, an average of 1 year

• Overall survival

  assessed up to 36 months

Study Arms (1)

Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy

EXPERIMENTAL

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.

Drug: • Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU

Interventions

• Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU DRUG

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.

Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic inoperable colorectal adenocarcinoma
• The tumour has a BRAF mutation
• 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).
• Absence of grade 2 or higher toxicity from previous line of treatment.
• It is possible to include patients with MSI or dMMR if they have received first-line immune checkpoint therapy.
• ECOG PS 0-1

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, Moscow, 115478, Russia

Location

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mikhail Fedyanin MD

  Blokhin's Russian Cancer Research Center

  PRINCIPAL INVESTIGATOR

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: Trametinib * Drug: Cetuximab * Drug: Рanitumumab * Drug: Oxaliplatin * Drug: Irinotecan * Drug: Leucovorin * Drug: 5-FU

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 13, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): June 10, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)