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

Phase 2

Active, not recruiting

• Conditions: Neoplasms

• Registration Number: NCT06967155
• Lead Sponsor: Blokhin's Russian Cancer Research Center

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.

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.

Study Timeline

• Study Start: 2025-03-01
• Study First Submitted: 2025-04-25
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-03
• Last Update Submitted: 2025-05-03
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-11-10
• Study Completion: 2028-06-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Histologically confirmed metastatic inoperable colorectal adenocarcinoma
2. The tumour has a BRAF mutation
3. Adequate function of hematopoiesis and basic indicators of internal organs
4. Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
5. Absence of grade 2 or higher toxicity from previous line of treatment.
6. It is possible to include patients with MSI or dMMR if they have received first-line immune checkpoint therapy.
7. ECOG PS 0-1

Exclusion Criteria

1. 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).
2. Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment.
3. Pregnant and breastfeeding women.
4. Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study.
5. HIV-infected patients.
6. Patients with a life expectancy of less than 3 months.
7. The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	assessed up to 12 months	From date of enrollment until the date of first documented progression

Secondary Outcome Measures

Name	Time	Method
Time to objective response	assessed up to 6 months	Time from start of treatment to objective response to treatment
Duration of response	assessed up to 12 months	Calculated from achieving objective response to progression or death from any cause
Disease control rate	Percentage of patients who achieved a complete response, partial response or disease stabilisation? through study completion, an average of 1 year
Incidence of adverse events grade 3-4	Proportion of patients with adverse events grade 3-4 out of all patients (NCI CTCAE 5.0)
Frequency of dose reductions and drug withdrawals	Proportion of patients with dose reductions and drug withdrawals in the total number of patients
Progression-free survival	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
Overall survival	assessed up to 36 months	From the time of enrolment until the death from any cause
Incidence of adverse events	Proportion of patients with adverse events out of all patients (NCI CTCAE 5.0)

Trial Locations

Locations (1)

Blokhin's Russian Cancer Research Center; 🇷🇺 Moscow, Russian Federation