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Tests treatment safety and results for Colorectal Cancer
Official title Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer
ClinicalTrials.gov ID: NCT06207656
What this study is testing
What is EBC?
EBC is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for 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
- As a result of the little benefit obtained from standard treatments and the poor prognosis of these patients, the BRAF-V600E mutant MSS aCRC represents an unmet medical need requiring clinical research. The combination of encorafenib, cetuximab and binimetinib as second- or third-line treatment for mCRC resulted in significantly better outcomes than standard therapy in a phase 3 clinical trial, which also revealed treatment safety and tolerability to be acceptable.
- 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
- 1\. Male or female participants age ≥18 years at the time of informed consent. 2. Capable of giving signed informed consent/assent. 3. Participants...
- Locally advanced colorectal cancer with initially unresectable but potentially resectable disease according to the local Multidisciplinary Tumour...
- Oligometastatic colorectal cancer (possible metastasis sites: liver, lung, lymph nodes and peritoneum) with: i. Initially resectable disease...
- ANC ≥1.5 × 109/L
- Platelets ≥100 × 109/L
You likely can't join if
- 1\. Any medical or psychiatric condition including recent (within the past year) or current suicidal ideation/behavior or laboratory abnormality that...
- History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or...
- Congestive heart failure requiring treatment (New York Heart Association Grade ≥2).
- History or presence of clinically significant cardiac arrhythmias (including uncontrolled atrial fibrillation or uncontrolled paroxysmal...
- History of thromboembolic or cerebrovascular events ≤12 weeks prior to the start of study treatment. Examples include transient ischemic attacks...
- Triplicate average QTcF interval ≥480 ms or a history of prolonged QT syndrome.
See the full eligibility criteria
- 1\. Male or female participants age ≥18 years at the time of informed consent. 2. Capable of giving signed informed consent/assent. 3. Participants who are willing and able to comply with all scheduled visits, treatment...
- Locally advanced colorectal cancer with initially unresectable but potentially resectable disease according to the local Multidisciplinary Tumour Board (MTB).
- Oligometastatic colorectal cancer (possible metastasis sites: liver, lung, lymph nodes and peritoneum) with: i. Initially resectable disease according to the local MTB or ii. Initially unresectable but potentially...
- ANC ≥1.5 × 109/L
- Platelets ≥100 × 109/L
- Hemoglobin ≥9.0 g/dL (with or without blood transfusions). 11. Adequate hepatic and renal function characterized by the following at screening:
- Serum total bilirubin ≤1.5 x ULN. Note 1: 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 2: Participants with hyperbilirubinemia due...
- ALT and AST ≤2.5 × ULN, or ≤5 × 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...
- 1\. Any medical or psychiatric condition including recent (within the past year) or current suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the...
- History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤6 months prior to the start of study treatment.
- Congestive heart failure requiring treatment (New York Heart Association Grade ≥2).
- History or presence of clinically significant cardiac arrhythmias (including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia).
- History of thromboembolic or cerebrovascular events ≤12 weeks prior to the start of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e., massive or...
- Triplicate average QTcF interval ≥480 ms or a history of prolonged QT syndrome.
- Congenital LQTS. 7. Evidence of active non-infectious pneumonitis. 8. Evidence of active and uncontrolled bacterial or viral infection, with certain exceptions, as noted below, for chronic infection with HIV, hepatitis...
- A stable regimen of highly active anti-retroviral therapy that is not contraindicated.
- No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections.
- A CD4 count \>250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests. 10\. Active hepatitis B or hepatitis C infection a. Active HBV is defined as any of the following:
- HBsAg (+), HBV DNA \>200 IU/mL (105 copies/mL);
- HBsAg (+), HBV DNA ≤200 IU/mL and persistent or intermittent elevation of ALT/AST and/or liver biopsy showing chronic hepatitis with moderate or severe necroinflammation. Note: Participants who are HBsAg (-), HBcAb (+)...
- HCV antibody positive; AND
- Presence of HCV RNA. 11. Concurrent or previous other malignancy within 3 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the...
- Patients with resected (R0 or R1 resections) metastasis of CRC treated with or without adjuvant or neoadjuvant chemotherapy (+/- antiEGFR or bevacizumab) would be includible if the time from the resection or from the...
- Patients with previous adjuvant or neoadjuvant chemotherapy for resected St II/III CRC would be eligible if the time from the resection or from the end of the adjuvant treatment (the later) to the relapse of CRC were...
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Madrid, 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.