Loading clinical trials...

Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer

A Phase Ia/II, Single Arm Trial on the Efficacy of Vemurafenib in Combination With Irinotecan and Cetuximab in BRAF V600E-Mutant Metastatic Colorectal Cancer

NCT04790448•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This prospective, multicenter, single arm clinical trial was designed to evaluate the efficacy and safety of Vemurafenib in combination with Irinotecan and Cetuximab in the treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer.

Detailed Description

PRIMARY OBJECTIVES: To evaluate the Overall Response Rate (ORR) of v-raf murine sarcoma viral oncogene homolog B (BRAF) V600E mutant metastatic colorectal cancer patients treated with Vemurafenib in combination with Irinotecan and Cetuximab (VIC regimen). SECONDARY OBJECTIVES: To evaluate the Progression Free Survival (PFS), Overall Survival (OS), safety and toxicity of VIC regimen in the treatment of BRAF V600E mutant colon cancer. EXPLORATORY OBJECTIVES: Mechanism of primary and secondary resistance to VIC regimen in the treatment of BRAF V600E mutant colon cancer. OUTLINE: Patients receive Cetuximab and Irinotecan intravenously on day 1 and Vemurafenib orally (PO) twice daily (BID) on days 1 to 14. Courses are repeated every 2 weeks in the absence of disease progression or unacceptable toxicity.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed diagnosis of metastatic colorectal cancer
•Histopathological or ctDNA analysis positive for BRAF V600E mutant
•Patients must have had at least undergone one first line treatment with FOLFOX or FOLFIRI or FOLFOXIRI±Bevacizumab before disease progression.
•Measurable and assessable disease according to RECIST 1.1 criteria
•Adequate hematologic function (Platelet\>90×109/L; White blood cells\>3.0×109/L; Neutrophils\>1.5×109/L; Hb\>10.0g/100ml)
•Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminase ≤5 times ULN
•No ascites, normal coagulation function, albumin ≥35g/L
•Child-Pugh class A
•Serum creatinine is less than the upper limit of normal (ULN), or calculated creatinine clearance rate\> 50ml/min (using Cockcroft-Gault equation)
•ECOG performance status of grade 0-2
+3 more criteria

Exclusion Criteria

•Patients with KRAS and NRAS mutations
•Previously received anti-EGFR monoclonal antibodies or EGFR inhibitors, BRAF inhibitors (with the exception of regorafenib)
•Patients with known contraindications to receiving cetuximab or irinotecan at the planned dose
•Patients with retinal vein occlusion or have current risk factors for retinal vein occlusion (for example, uncontrolled glaucoma or ocular hypertension)
•History of acute or chronic pancreatitis
•History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive drugs or surgery) within 12 months prior to enrollment
•Gastrointestinal diseases that may greatly affect the absorption of Vimurafenib (for example, ulcer disease, uncontrolled vomiting, malabsorption syndrome, small bowel resection and reduced intestinal absorption)
•Neuromuscular diseases associated with elevated CK (eg, inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
•Patients with any residual CTCAE ≥ Grade 2 toxicity from previous anti-tumor therapy (excluding hair loss or neuropathy of Grade 2 and above)
•History of HIV infection
+13 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

July 27, 2020

Primary Completion Date

December 31, 2021

Completion Date

December 31, 2021

Last Updated

February 15, 2023

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer Metastatic

Interventions

Cetuximab

DRUG

Irinotecan

DRUG

Vemurafenib

DRUG

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer

NCT05759728

Colorectal Cancer Metastatic

View study

RECRUITINGEARLY_PHASE1

COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer

NCT07328087

Colorectal Cancer MetastaticColorectal Cancer Stage III+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer

COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer

STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer

A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.

A Study of VS-6766 and Cetuximab in Patients With Advanced Colorectal Cancer

Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis