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NCT Number: NCT06967155

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blokhin's Russian Cancer Research Center

Moscow, 115478, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

• 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.

Primary outcomes

  1. Objective Response Rate

    Time frame: assessed up to 12 months

    From date of enrollment until the date of first documented progression

Secondary outcomes

  1. Progression-free survival

    Time frame: assessed up to 24 months

    From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first

  2. Time to objective response

    Time frame: assessed up to 6 months

    Time from start of treatment to objective response to treatment

  3. Duration of response

    Time frame: assessed up to 12 months

    Calculated from achieving objective response to progression or death from any cause

  4. Disease control rate

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

  5. Overall survival

    Time frame: assessed up to 36 months

    From the time of enrolment until the death from any cause

  6. Incidence of adverse events

    Time frame: Proportion of patients with adverse events out of all patients (NCI CTCAE 5.0)

  7. Incidence of adverse events grade 3-4

    Time frame: Proportion of patients with adverse events grade 3-4 out of all patients (NCI CTCAE 5.0)

  8. Reduction of dose reductions and drug withdrawals

    Time frame: Proportion of patients with dose reductions and drug withdrawals in the total number of patients

Sponsors and collaborators

Lead sponsor

Blokhin's Russian Cancer Research Center

Other

Collaborators

  • City Clinical Oncology Hospital No 1
  • Moscow City Oncology Hospital No. 62
  • Moscow Multidisciplinary Clinical Center "Kommunarka"
  • The Loginov MCSC MHD

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 13, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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