Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic C… (NCT04044430) | Clinical Trial Compass
TerminatedPhase 1
Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer
Stopped: Sponsor funding
United States2 participantsStarted 2020-08-31
Plain-language summary
This phase I/II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that has spread to other places in the body (metastatic). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may work better in treating patients with colorectal cancer compared to standard treatments.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and/or metastatic disease that is measurable according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
* Confirmation of BRAFV600E tumor as detected from testing performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
* Confirmation of MSS status from testing performed in a CLIA-certified laboratory
* Prior treatment with at least one systemic chemotherapy regimen for mCRC, or recurrence/progression with development of unresectable or metastatic disease within 6 months of adjuvant chemotherapy for resected CRC
* Eastern Cooperative Oncology Group performance status (ECOG PS) =\< 1 (Karnofsky \>= 70%)
* Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L
* Hemoglobin (Hgb) \>= 9 g/dL with or without transfusions
* Platelets (PLT) \>= 100 x 10\^9/L without transfusions
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) and \< 2 mg/dL
* Note: Patients who have a total bilirubin level \> 1.5 x ULN and/or have Gilbert's disease will be allowed if their direct bilirubin level is =\< 0.5 mg/dl or ULN, whichever is higher.
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =\< 3 x ULN
* Serum creatinine =\< 1.5 x ULN, or calculated creatinine clearance (determined as per Cockcroft-Gault) \>= 50 mL/min at screening
* Corrected QT (QT…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiographic Response
Timeframe: Up to 3 years
2
Best investigator-assessed response
Timeframe: Up to 3 years
3
Incidence of treatment-related grade 3 or higher adverse events (AEs)