A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer

Plain-language summary

This study investigates the first-line use of FOLFOX chemotherapy together with Dabrafenib and either Cetuximab or Panitumumab in people with metastatic colorectal cancer. It enrolls patients with inoperable metastatic colorectal adenocarcinoma that is MSS and carries a BRAF V600E mutation. It is in Phase 2 and is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

Blokhin's Russian Cancer Research Center

Intervention

mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy

Start date

3/1/2025

Estimated completion

7/10/2028

Countries

Russia

Related genes

Locations

• Moscow, Russia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation
* Metastatic inoperable colorectal cancer
* 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).
* Lacking antitumor systemic treatment for colorectal cancer.
* Patients with progression after adjuvant chemotherapy may be included if progression is recorded no earlier than 12 months after the last course of chemotherapy.
* The primary tumor is removed or asymptomatic.
* Absence of grade 2 or higher neuropathy.
* Absence of tumor MSI or dMMR.
* ECOG PS 0-2

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.