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

Blokhin's Russian Cancer Research Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06967155

05202500302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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