Actively Recruiting
Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-02-12
25
Participants Needed
3
Research Sites
108 weeks
Total Duration
On this page
Sponsors
F
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor
P
Pierre Fabre Pharma GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to determine the activity of encorafenib plus cetuximab in combination with FOLFIRI in patients with BRAF V600E mutated metastatic colorectal cancer progressing on encorafenib plus cetuximab administered in second line.
CONDITIONS
Official Title
Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent to study procedures
- Age 18 years or older
- Histologically or cytologically confirmed colorectal adenocarcinoma
- Radiological evidence of metastatic disease
- Measurable disease according to RECIST 1.1 criteria
- Presence of BRAF V600E mutation in tumor tissue by PCR or NGS local assay
- Disease progression while on encorafenib plus cetuximab (EC) in second line
- Best response to previous EC treatment: complete response, partial response, or stable disease lasting at least 3 months
- Patient fit for treatment with FOLFIRI chemotherapy
- Life expectancy of 3 months or more
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 1 or less
- Adequate bone marrow function: ANC ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 9.0 g/dL
- Adequate renal function: serum creatinine ≤ 1.5 × upper limit normal or creatinine clearance ≥ 50 mL/min
- Adequate hepatic function: total bilirubin ≤ 1.5 × ULN; ALT and/or AST ≤ 2.5 × ULN or ≤ 5 × ULN if liver metastases present
- Adequate cardiac function with QTcF ≤ 480 msec
- Availability of treatment-naïve archival tumor tissue sample
- Ability to take oral medications
- Males with female partners of childbearing potential must use contraception during treatment and 180 days after
- Women of childbearing potential must have a negative pregnancy test and use contraception during treatment and 180 days after
- Willingness and ability to comply with the protocol
You will not qualify if you...
- Progressive disease as best response to previous encorafenib plus cetuximab treatment
- Contraindications to BRAF inhibitors or anti-EGFR agents
- Contraindications to irinotecan or fluoropyrimidines
- DPYD deficiency
- Life expectancy less than 3 months
- ECOG Performance Status greater than 1
- Recent serious cardiac events or conditions within 6 months prior to treatment
- Congenital long QT syndrome
- Gastrointestinal conditions impairing absorption of encorafenib
- Uncontrolled bleeding disorders
- Gilbert's syndrome or specific UGT1A1 genotypes
- Active infection requiring systemic therapy
- History of acute or chronic pancreatitis
- Known HIV/AIDS or active hepatitis B or C infection
- Symptomatic brain metastasis or leptomeningeal disease
- Prior hypersensitivity preventing planned treatment
- Residual grade 3 or higher toxicity from prior cancer therapy except alopecia or neuropathy
- Use of drugs contraindicated with study drugs or strong CYP3A4 inhibitors within 1 week prior
- Use of St. John's Wort
- Other severe medical or psychiatric conditions increasing risk or interfering with study
- Other malignancies within 3 years except certain treated noninvasive cancers
- Pregnant or lactating women or women with positive or no pregnancy test at baseline
- Sexually active males or females unwilling to use contraception during and 180 days after the study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Not Yet Recruiting
2
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Roma, Italy, 00136
Actively Recruiting
3
Ospedale Cardinale G. Panico
Tricase, Italy, 73039
Actively Recruiting
Research Team
M
Maria Alessandra Calegari
CONTACT
M
Maria Alessandra Calegari
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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