Clinical trial NCT06967155: A Study of Irinotecan With Dabrafenib Plus Trametinib and Anti-EGFR in the Second Line of Therapy in People With Metastatic Colorectal Cancer
Official 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Neoplasms
Keywords: metastatic colorectal cancer
BRAF V600E- mutated
treatment
Lead sponsor: Blokhin's Russian Cancer Research Center
Sponsor class: OTHER
Collaborators: name: City Clinical Oncology Hospital No 1
name: Moscow City Oncology Hospital No. 62
name: The Loginov MCSC MHD
name: MMCC Kommunarka MHD
First posted: 2025-05-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: * Drug: Dabrafenib
* Drug: Trametinib
* Drug: Cetuximab
* Drug: Рanitumumab
* Drug: Oxaliplatin
* Drug: Irinotecan
* Drug: Leucovorin
* Drug: 5-FU
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: assessed up to 12 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: assessed up to 24 months
measure: Time to objective response
timeFrame: assessed up to 6 months
measure: Duration of response
timeFrame: assessed up to 12 months
measure: Disease control rate
timeFrame: Percentage of patients who achieved a complete response, partial response or disease stabilisation? through study completion, an average of 1 year
measure: Overall survival
timeFrame: assessed up to 36 months
measure: Incidence of adverse events
timeFrame: Proportion of patients with adverse events out of all patients (NCI CTCAE 5.0)
measure: Incidence of adverse events grade 3-4
timeFrame: Proportion of patients with adverse events grade 3-4 out of all patients (NCI CTCAE 5.0)
measure: Frequency of dose reductions and drug withdrawals
timeFrame: Proportion of patients with dose reductions and drug withdrawals in the total number of patients
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Blokhin's Russian Cancer Research Center
Study officials:
affiliation: Blokhin's Russian Cancer Research Center
name: Mikhail Fedyanin MD
role: PRINCIPAL_INVESTIGATOR
References: