Clareo Health | A Study of Irinotecan With Dabrafenib Plus Trametinib and Anti-EGFR in the Second Line of Therapy in People With Metastatic Colorectal Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Blokhin's Russian Cancer Research Center
With
City Clinical Oncology Hospital No 1
Moscow City Oncology Hospital No. 62
The Loginov MCSC MHD
Moscow Multidisciplinary Clinical Center "Kommunarka"
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.
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
You may not be if
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.
