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New treatment option for Metastatic Colorectal Cancer
Official title Combination Therapy for BRAF-V600E Metastatic CRCm
ClinicalTrials.gov ID: NCT06411600
What this study is testing
What is Encorafenib?
Encorafenib is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The BRAVE is a phase II clinical trial aimed at evaluating the efficacy of the combination therapy of encorafenib, cetuximab, and bevacizumab in patients with metastatic colorectal cancer (CRC) harboring the BRAF-V600E mutation. This mutation is present in about 8-10% of CRC cases and is associated with poor prognosis and limited treatment options.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form.
- Age ≥18 years at time of informed consent.
- Histologically- or cytologically-confirmed mCRC that is metastatic.
- Presence of BRAF V600E mutation in tumor tissue previously determined according to the guidelines of each center, any time point before the...
- Microsatellite stability must be confirmed according to the guidelines of each center, any time point before the enrollment in the study.
You likely can't join if
- Treatment with another investigational drug or participation in another investigational study at enrolment or within 30 days prior to enrolment.
- Patient unable to comply with the study protocol owing to psychological, social (lack of social support or social exclusion) or geographical reasons.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
- Prior history of hypertensive crisis or hypertensive encephalopathy.
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to...
- Evidence of bleeding diathesis or clinically significant coagulopathy (in the absence of therapeutic anticoagulation).
See the full eligibility criteria
Who can join
- Provision of signed and dated informed consent form.
- Age ≥18 years at time of informed consent.
- Histologically- or cytologically-confirmed mCRC that is metastatic.
- Presence of BRAF V600E mutation in tumor tissue previously determined according to the guidelines of each center, any time point before the enrollment in the study.
- Microsatellite stability must be confirmed according to the guidelines of each center, any time point before the enrollment in the study.
- Eligible to receive cetuximab per locally approved label with regard to tumor RAS status, any time point before the enrollment in the study.
- Progression of disease after 1 or 2 prior regimens in the metastatic setting.
- Evidence of measurable or evaluable non-measurable disease per RECIST, v1.1.
- ECOG PS of 0 or 1.
- Adequate bone marrow function characterized by the following at screening:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Platelets ≥100 x 109/L
- Hemoglobin ≥9.0 g/dL (with or without blood transfusions).
- Adequate hepatic and renal function characterized by the following at screening:
- Serum total bilirubin ≤1.5 x upper limit of normal (ULN) and \ 1.5 x ULN is allowed if direct (conjugated) ≤1.5 x ULN and indirect (unconjugated) bilirubin is ≤4.25 x ULN. Note: Participants with hyperbilirubinemia due...
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5 x ULN, or ≤5 x ULN in the presence of liver metastases.
- Adequate renal function defined by an estimated creatinine clearance ≥50 mL/min according to the Cockcroft Gault formula or by 24-hour urine collection for creatinine clearance, or according to local institutional...
- Protein \< 2+ on dipstick urinalysis or ≤ 1.0 g in a 24-hour urine collection. All patients with ≥2+ protein on dipstick urinalysis at baseline must undergo a 24-hour urine collection for protein.
- Adequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits. Note: Replacement treatment to achieve adequate electrolytes will be allowed.
- Adequate cardiac function characterized by the following at screening: a.Mean triplicate QT interval corrected for heart rate using Fridericia's formula (QTcF) value ≤480 msec.
- Able to take oral medications.
- Highly effective contraception for both male and female people if the risk of conceptions exists during and at least up to 6 months after the last medication. See 10.4. Appendix 4.
What rules you out
- Treatment with another investigational drug or participation in another investigational study at enrolment or within 30 days prior to enrolment.
- Patient unable to comply with the study protocol owing to psychological, social (lack of social support or social exclusion) or geographical reasons.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
- Prior history of hypertensive crisis or hypertensive encephalopathy.
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1.
- Evidence of bleeding diathesis or clinically significant coagulopathy (in the absence of therapeutic anticoagulation).
- Patients with history of pulmonary hemorrhage/hemoptysis (\>1/2 teaspoon red blood) within 6 months prior to Cycle 1, Day 1.
- Known history of acute or chronic pancreatitis.
- Tumors with microsatellite instability or mismatch repair deficiency.
- History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention. (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months before the enrollment in the study.
- Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft [CABG], coronary angioplasty or stenting) ≤ 6 months prior to start of study treatment.
- Symptomatic congestive heart failure (i.e., Grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality ≤ 6 months prior to start of study treatment, except...
- Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy.
- Impaired hepatic function, defined as Child-Pugh class B or C.
- Known history of human immunodeficiency virus (HIV), active hepatitis B virus (HBV) infection or active hepatitis C virus (HCV) infection. Patients positive for HCV antibody are eligible only if polymerase chain...
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms...
- people with leptomeningeal carcinomatosis.
- Impaired gastrointestinal (GI) function or disease that may significantly alter the absorption of encorafenib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with...
- Concurrent or previous other malignancy within 5 years of study entry without Sponsor approval, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma...
- History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary embolism.
- Knowledge of any other disease or medication that may interfere with study treatment.
- Known severe hypersensitivity reactions to monoclonal anti-bodies or BRAF inhibitors.
- Known hypersensitivity to any of encorafenib, cetuximab or bevacizumab-bvzr active ingredients or their excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.