Clinical trial NCT06978400: A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First 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 FOLFOX With Dabrafenib and Cetuximab/Panitumumab in the First Line of Therapy of Patients With Metastatic BRAF V600E- Mutated MSS Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neoplasms
Keywords: metastatic colorectal cancer
BRAF V600E- mutated
first line
MSS
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: 2025-05-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: * Drug: Dabrafenib
* 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 FOLFOX regimen with dabrafenib and cetuximab/panitumumab in the first line of therapy for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene and MSS.

Participants in this study will receive one of the following study treatments:

These participants will receive FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy This study is currently enrolling participants who will receive either FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first 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 first-line FOLFOX with dabrafenib and cetuximab or panitumumab in patients with previously untreated metastatic inoperable colorectal cancer who have MSS and BRAF mutation.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: assessed at 8 and 16 weeks
Secondary outcomes:
measure: Progression-free survival
timeFrame: assessed up to 24 months
measure: Time to objective response
timeFrame: assessed up to 12 months
measure: Overall survival
timeFrame: assessed up to 36 months
Other outcomes:
measure: Duration of response
timeFrame: assessed up to 12 months
measure: Disease control rate
timeFrame: through study completion, an average of 1 year
measure: Incidence of adverse events
timeFrame: through study completion, an average of 1 year
measure: Incidence of adverse events grade 3-4
timeFrame: through study completion, an average of 1 year
measure: Frequency of dose reductions and drug withdrawals
timeFrame: through study completion, an average of 1 year
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: