Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V… (NCT04375527) | Clinical Trial Compass
TerminatedPhase 2
Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma
Stopped: poor enrollment
United States3 participantsStarted 2020-12-03
Plain-language summary
This phase II trial studies how well binimetinib and nivolumab work in treating patients with BRAF V600 wildtype melanoma that has spread to nearby tissues or lymph nodes and cannot be removed by surgery (locally advanced unresectable) or has spread to other places in the body (metastatic). 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 binimetinib and nivolumab together may work better in treating patients with melanoma compared to nivolumab alone.
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:
* Males or females age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Histologically confirmed locally advanced/unresectable or metastatic cutaneous melanoma
* Measurable disease per RECIST version (v.) 1.1 criteria using imaging scans, OR peripheral lesions that can be adequately documented with a picture and a ruler even if they do not meet RECIST criteria
* Patient must have failed prior alphaPD-1 or alphaPD-1 + alphaCTLA-4 therapy in the metastatic setting
* V600BRAF wildtype tumor status confirmed by Clinical Laboratory Improvement Act (CLIA) approved lab
* Hemoglobin \>= 8.0 g/dL
* Whole blood cell count (WBC) \>= 2,000/mm\^3
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count \>= 75,000/mm\^3
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x institutional upper limit of normal (ULN), (=\< 5.0 x ULN in those with hepatic metastases)
* Bilirubin =\< 1.5 x ULN; for subjects with documented/suspected Gilbert's disease, bilirubin =\< 3 x ULN
* Albumin \>= 2.5 g/dl
* Serum creatinine =\< 2.0 x upper limit of normal (ULN)
* Left ventricular ejection fraction (LVEF) \>= 50% assessed by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan completed =\< 180 days (6 months) before initiation of protocol treatment
* Patients must be willing to submit blood and tissue specimens for translational medicine studies
* Patients must have a site of disease amenable to biopsy and…
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.