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Phase III study in mCRC patients with RAS/BRAF wild type tissue and RAS/BRAF mutated in LIquid BIopsy to compare in first-line therapy FOLFIRI plus CetuxiMAb or BevacizumaB
EU CTIS ID: 2024-517863-22-00
What this study is testing
The primary objective of the study is to assess whether the combination of bevacizumab plus chemotherapy is superior to cetuximab plus chemotherapy in terms of PFS in patients with RAS/BRAF mut at liquid biopsy and RAS/BRAF wt on tissue
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provision of written informed consent
- If DPD status is known it must be wild type. No restrictions are applied if DPD status in unknown
- Women of childbearing potential must have a negative blood pregnancy test within 24 hr prior to the start of study treatment. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive
- Subjects and their partners must be willing to avoid pregnancy during the trial and until 5 months for WOCBP (Women of Childbearing Potential) and 7 months for male subjects with female partners of WOCBP after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the investigator (barriers contraceptive measure or oral contraception)
- Male or female > 18 years of age
- Histologically confirmed diagnosis of colorectal adenocarcinoma RAS/BRAF wild type (analysed either on primary and/or related metastasis)
You likely can't join if
- Previous chemotherapy treatment, with the exception of patient treated in adjuvant setting completed at least 6 months before the randomization
- History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection
- Chronic, daily treatment with high-dose aspirin (>325 mg/day)
- Any previous venous thromboembolism > NCI CTCAE Grade 3
- History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment. History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
See the full eligibility criteria
Who can join
- Provision of written informed consent
- If DPD status is known it must be wild type. No restrictions are applied if DPD status in unknown
- Women of childbearing potential must have a negative blood pregnancy test within 24 hr prior to the start of study treatment. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive
- Subjects and their partners must be willing to avoid pregnancy during the trial and until 5 months for WOCBP (Women of Childbearing Potential) and 7 months for male subjects with female partners of WOCBP after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the investigator (barriers contraceptive measure or oral contraception)
- Male or female > 18 years of age
- Histologically confirmed diagnosis of colorectal adenocarcinoma RAS/BRAF wild type (analysed either on primary and/or related metastasis)
- Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease
- Patients suitable for first line chemotherapy
- Life expectancy > 3 months
- At least one site of measurable disease per RECIST 1.1
- ECOG Performance status ≤ 2
- Adequate bone marrow, liver and renal function assessed before starting study treatment
What rules you out
- Previous chemotherapy treatment, with the exception of patient treated in adjuvant setting completed at least 6 months before the randomization
- History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection
- Chronic, daily treatment with high-dose aspirin (>325 mg/day)
- Any previous venous thromboembolism > NCI CTCAE Grade 3
- History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment. History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
- Current, recent (within 10 days prior to study treatment start) or ongoing treatment with anticoagulants for therapeutic purposes. Patients with an active therapy with low molecular weight heparin or NAO may be enrolled
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study
- History of any severe hypersensitivity reactions to any monoclonal antibody
- A significant concomitant disease which, in the investigating physician's opinion, rules out the patient’s participation in the study
- Any contraindication to the use of Cetuximab, Bevacizumab, Irinotecan, 5FU or folinic acid
- Radiotherapy to any site within 4 weeks before the randomization
- Serious, non-healing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
- Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy
- Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- Active and untreated brain (CNS) metastases and/or carcinomatous meningitis
- Active infection requiring systemic therapy or active disseminated intravascular coagulation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.