Metastatic Colorectal CancerPhase 2BRAVENCT06411600
Combination Therapy for BRAF-V600E Metastatic CRCm
A Phase 2 study testing Encorafenib, Cetuximab and Bevacizumab in people with Metastatic Colorectal Cancer, run by Vall d'Hebron Institute of Oncology at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Encorafenib, Cetuximab and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSpain
- Study dates
- 17 May 2024to 1 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
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- 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 <2 mg/dL. Note: Total bilirubin >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 to non-hepatic cause (e.g., hemolysis, hematoma) may be enrolled following discussion and agreement with the Sponsor medical monitor.
- 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 standard method.
- 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 subjects if the risk of conceptions exists during and at least up to 6 months after the last medication. See 10.4. Appendix 4.
Who cannot join
- 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).
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- 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 atrial fibrillation and paroxysmal supraventricular tachycardia.
- 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 reaction is negative for HCV RNA. Patients with past exposure to HBV are also eligible for the study provided they are negative for HBV DNA.
- 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. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and the enrollment in the study.
- Subjects 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 decreased intestinal absorption).
- 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 in-situ of the cervix, or other noninvasive or indolent malignancy.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Susana Muñoz contact
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron Hospital
Barcelona, 08035
Elena Élez, MD PhD, meelez@vhio.net
About this study
Official title: Bevacizumab Plus encoRAfenib-cetuximab in BRAF-V600E Mutated Metastatic Colorectal Cancer, a Phase II Study With a Safety lead-in Cohort, the BRAVE Trial
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. The rationale behind this trial stems from preclinical studies suggesting that the overexpression and activation of vascular endothelial growth factor A (VEGFA) may contribute to resistance to BRAF inhibitors (BRAFi) in CRC. Thus, the trial hypothesizes that adding bevacizumab, an anti-angiogenic agent targeting VEGFA, to the combination of encorafenib and cetuximab may delay acquired resistance, leading to improved progression-free survival.
The primary objective of the BRAVE is to evaluate the antitumor activity of the encorafenib-cetuximab-bevacizumab combination in patients who have experienced disease progression after one or two chemotherapy regimens for BRAF V600E-mutant metastatic CRC. This activity will be assessed based on the confirmed progression-free survival rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Read the detailed description
Study Design: The study adopts a multicenter, open-label, phase II design. Patients with metastatic CRC harboring the BRAF-V600E mutation, who have experienced disease progression after one or two prior chemotherapy regimens, are eligible for enrollment. The treatment regimen consists of daily oral encorafenib (300 mg), biweekly intravenous cetuximab (500 mg/m2), and biweekly intravenous bevacizumab (5 mg/kg). Treatment will be administered in 28-day cycles until disease progression, unacceptable toxicity, consent withdrawal, initiation of other anticancer therapy, or death.
Secondary Objectives: Secondary objectives include evaluating the safety and tolerability of the combination therapy, assessing objective response rate, time to response, duration of response, overall survival, and patient-reported outcomes. Exploratory objectives involve evaluating potential biomarkers predictive of treatment response and resistance, as well as generating functional models to assess novel drug combinations targeting resistance mechanisms.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Encorafenib, Cetuximab, Bevacizumab
- Keywords
- Encorafenib, Cetuximab, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EncorafenibDrug
Encorafenib is administered orally at a daily dose of 300 mg, typically in the form of four 75 mg capsules taken together.
CetuximabDrug
Cetuximab is administered intravenously every two weeks at a dose of 500 mg/m².
BevacizumabDrug
Bevacizumab is administered intravenously every two weeks at a dose of 5 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | The experimental arm in the BRAVE protocol involves the administration of a combination therapy consisting of encorafenib, cetuximab, and bevacizumab. This arm is designed to evaluate the efficacy and safety of this combination in patients with metastatic colorectal cancer harboring the BRAF-V600E mutation who have experienced disease progression after one or two prior chemotherapy regimens. The primary objective is to assess the antitumor activity of the combination therapy, with secondary objectives including safety and tolerability assessments, as well as evaluations of progression-free survival, overall survival, and patient-reported outcomes. Receives: Drug: Encorafenib; Drug: Cetuximab; Drug: Bevacizumab |
| Control arm | Active comparator | The control arm in the BRAVE protocol involves standard-of-care treatment, which may include various chemotherapy regimens or targeted therapies typically used for metastatic colorectal cancer. In this arm, patients receive the standard treatment without the addition of encorafenib, cetuximab, or bevacizumab. The purpose of the control arm is to provide a reference point for comparing the efficacy and safety of the experimental combination therapy. Patients in this arm may also undergo similar assessments for tumor response, survival outcomes, and adverse events to facilitate comparison with the experimental arm. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS will be evaluated by local radiologist/investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). It refers to the duration from the start of treatment until disease progression or death due to any cause.
Measured: Until disease progression, typically within a follow-up period of approximately 5 years.
Secondary outcomes (5)
Objective Response Rate (ORR)
ORR will be determined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
Measured: Throughout the study duration, that it will take 5 years
Duration of Response (DOR)
DOR is defined as the duration from the first radiographic evidence of response to the earliest documented disease progression or death due to underlying disease.
Measured: Until disease progression, typically within a follow-up period of approximately 5 years.
Disease Control Rate (DCR)
The proportion of patients who achieve a complete response, partial response, or stable disease as the best overall response to treatment.
Measured: Throughout the study duration, that it will take 5 years
Electrocardiogram (ECG) Changes
This outcome measure assesses changes in electrocardiogram (ECG) parameters in participants receiving treatment with encorafenib in combination with cetuximab and bevacizumab, as well as up to 30 ± 2 days after the last dose. ECG recordings will be analyzed for parameters such as QT interval duration, presence of arrhythmias, and other relevant ECG changes.
Measured: During treatment (until disease progression) and up to 30 ± 2 days after the last dose.
Incidence and Severity of Adverse Events
This outcome measure assesses the occurrence and severity of adverse events experienced by participants during treatment with encorafenib in combination with cetuximab and bevacizumab, as well as up to 30 ± 2 days after the last dose. Adverse events will be categorized and graded according to standardized criteria (e.g., CTCAE version 5.0).
Measured: Until disease progression, typically within a follow-up period of approximately 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start17 May 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Elez, MD PhD, Principal investigator, Vall d'Hebron Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411600
- Sponsor's protocol ID
- VHIO23001
- Acronym
- BRAVE
- Status last verified
- Nov 2024
- First submitted
- 24 Apr 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab Plus encoRAfenib-cetuximab in BRAF-V600E Mutated Metastatic Colorectal Cancer, a Phase II Study With a Safety lead-in Cohort, the BRAVE Trial
- ClinicalTrials.gov ID
- NCT06411600
- Acronym / sponsor ID
- BRAVE / VHIO23001
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Encorafenib, Cetuximab, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Vall d'Hebron Institute of OncologyUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The rationale behind this trial stems from preclinical studies suggesting that the overexpression and activation of vascular endothelial growth factor A (VEGFA) may contribute to resistance to BRAF inhibitors (BRAFi) in CRC. Thus, the trial hypothesizes that adding bevacizumab, an anti-angiogenic agent targeting VEGFA, to the combination of encorafenib and cetuximab may delay acquired resistance, leading to improved progression-free survival.
The primary objective of the BRAVE is to evaluate the antitumor activity of the encorafenib-cetuximab-bevacizumab combination in patients who have experienced disease progression after one or two chemotherapy regimens for BRAF V600E-mutant metastatic CRC. This activity will be assessed based on the confirmed progression-free survival rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Detailed description
Study Design: The study adopts a multicenter, open-label, phase II design. Patients with metastatic CRC harboring the BRAF-V600E mutation, who have experienced disease progression after one or two prior chemotherapy regimens, are eligible for enrollment. The treatment regimen consists of daily oral encorafenib (300 mg), biweekly intravenous cetuximab (500 mg/m2), and biweekly intravenous bevacizumab (5 mg/kg). Treatment will be administered in 28-day cycles until disease progression, unacceptable toxicity, consent withdrawal, initiation of other anticancer therapy, or death.
Secondary Objectives: Secondary objectives include evaluating the safety and tolerability of the combination therapy, assessing objective response rate, time to response, duration of response, overall survival, and patient-reported outcomes. Exploratory objectives involve evaluating potential biomarkers predictive of treatment response and resistance, as well as generating functional models to assess novel drug combinations targeting resistance mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Encorafenib, Drug: Cetuximab, Drug: BevacizumabThe experimental arm in the BRAVE protocol involves the administration of a combination therapy consisting of encorafenib, cetuximab, and bevacizumab. This arm is designed to evaluate the efficacy and safety of this combination in patients with metastatic colorectal cancer harboring the BRAF-V600E mutation who have experienced disease progression after one or two prior chemotherapy regimens. The primary objective is to assess the antitumor activity of the combination therapy, with secondary objectives including safety and tolerability assessments, as well as evaluations of progression-free survival, overall survival, and patient-reported outcomes. |
| Control arm | Active comparator | Drug: BevacizumabThe control arm in the BRAVE protocol involves standard-of-care treatment, which may include various chemotherapy regimens or targeted therapies typically used for metastatic colorectal cancer. In this arm, patients receive the standard treatment without the addition of encorafenib, cetuximab, or bevacizumab. The purpose of the control arm is to provide a reference point for comparing the efficacy and safety of the experimental combination therapy. Patients in this arm may also undergo similar assessments for tumor response, survival outcomes, and adverse events to facilitate comparison with the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EncorafenibEncorafenib is administered orally at a daily dose of 300 mg, typically in the form of four 75 mg capsules taken together. | Drug | Experimental arm |
| CetuximabCetuximab is administered intravenously every two weeks at a dose of 500 mg/m². | Drug | Experimental arm |
| BevacizumabBevacizumab is administered intravenously every two weeks at a dose of 5 mg/kg. | Drug | Control arm, Experimental arm |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Until disease progression, typically within a follow-up period of approximately 5 years.
PFS will be evaluated by local radiologist/investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). It refers to the duration from the start of treatment until disease progression or death due to any cause.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Throughout the study duration, that it will take 5 years
Duration of Response (DOR)
Time frame: Until disease progression, typically within a follow-up period of approximately 5 years.
Disease Control Rate (DCR)
Time frame: Throughout the study duration, that it will take 5 years
Electrocardiogram (ECG) Changes
Time frame: During treatment (until disease progression) and up to 30 ± 2 days after the last dose.
Incidence and Severity of Adverse Events
Time frame: Until disease progression, typically within a follow-up period of approximately 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susana Muñoz contact
Elena Elez, MD PhD principal investigator
Vall d'Hebron Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Encorafenib, Cetuximab and Bevacizumab in people with Metastatic Colorectal Cancer, run by Vall d'Hebron Institute of Oncology at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Elez, MD PhD (+34 932744350, meelez@vhio.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Until disease progression, typically within a follow-up period of approximately 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.