BridgeMD
Compares treatment options for Acral Lentiginous Melanoma
Official title A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
ClinicalTrials.gov ID: NCT04511013
What this study is testing
What is Binimetinib?
Binimetinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acral lentiginous melanoma.
Also referred to as ARRY-162, ARRY-438162.
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
- This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Participants must have histologically and pathologically confirmed melanoma that has metastasized to the brain
- Any primary (cutaneous, acral/mucosal, etc) or unknown origin are permitted, except that participants with uveal primary are not eligible
- Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- All participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system...
- Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to...
You likely can't join if
- Participants must not have received prior systemic therapy for metastatic disease. Prior systemic therapy received only in the neoadjuvant and/or...
- Participants must not have had prior radiation therapy within 7 days prior to randomization
- Participants must not be planning to require any additional form of systemic anti-tumor therapy for melanoma while on protocol treatment
- Participants must not be planning to use hormonal contraceptives
- Participants must not have a serious active infection requiring systemic therapy at time of randomization in the opinion of the treating physician
- Participants must not have active autoimmune disease that has required treatment in the past 6 months with use of biologic disease modifying agents...
See the full eligibility criteria
Who can join
- Participants must have histologically and pathologically confirmed melanoma that has metastasized to the brain
- Any primary (cutaneous, acral/mucosal, etc) or unknown origin are permitted, except that participants with uveal primary are not eligible
- Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- All participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system metastases with at least one measurable brain metastasis \>= 0.5 cm...
- Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to randomization; all non-measurable disease must be assessed within 42 days prior to...
- Participants may have leptomeningeal disease
- Participants may be receiving corticosteroids for brain metastases at a dose of up to 8 mg of dexamethasone per day. The dose must not have exceeded 8 mg per day for at least 7 days prior to randomization
- Participants must have Zubrod performance status =\< 2
- Participants must have complete history and physical examination within 28 days prior to randomization
- Participants must be able to swallow and retain pills
- Hemoglobin \>= 8.0 g/dL (within 28 days prior to randomization)
- Absolute neutrophil count \>= 1,500/mcL (within 28 days prior to randomization)
- Platelets \>= 75,000/mcL (within 28 days prior to randomization)
- Total bilirubin =\< 1.5 institutional upper limit of normal (ULN) (within 28 days prior to randomization)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional ULN (in participants with liver metastases =\< 5 x ULN) (within 28 days prior to randomization)
- Creatinine =\< 2.0 institutional ULN (within 28 days prior to randomization)
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association...
- Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or how well it works assessment...
- Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within...
- Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to...
- Participants must agree to participate in image banking. Images must be submitted via the Triad System
- Participants must be offered the opportunity to participate in specimen and blood collections
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been...
What rules you out
- Participants must not have received prior systemic therapy for metastatic disease. Prior systemic therapy received only in the neoadjuvant and/or adjuvant setting (e.g., BRAF/MEK inhibitor therapy, anti-PD-1 therapy or...
- Participants must not have had prior radiation therapy within 7 days prior to randomization
- Participants must not be planning to require any additional form of systemic anti-tumor therapy for melanoma while on protocol treatment
- Participants must not be planning to use hormonal contraceptives
- Participants must not have a serious active infection requiring systemic therapy at time of randomization in the opinion of the treating physician
- Participants must not have active autoimmune disease that has required treatment in the past 6 months with use of biologic disease modifying agents (.e.g. infliximab, adalimumab). Patients on non-biologic disease...
- Participants must not have had grade 3 or 4 immune-related adverse events on ipilimumab or nivolumab that required more than 12 weeks of immune suppression with corticosteroids
- Participants must not have had adverse events related to encorafenib and/or binimetinib specifically, that required discontinuation of one or both drugs. (Please note this does not apply to other BRAF/MEK inhibitor...
- Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective method of contraception. (NOTE: Patients must agree to not use hormonal contraceptives, as...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Fairhope, Alabama, United States
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Fort Smith, Arkansas, United States
- Burbank, California, United States
- Dublin, California, United States
- Emeryville, California, United States
- Los Angeles, California, United States
- Martinez, California, United States
- Napa, California, United States
- Oakland, California, United States
- San Diego, California, United States
- Santa Rosa, California, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Boulder, Colorado, United States
- Centennial, Colorado, United States
- Denver, Colorado, United States
+ 217 more site(s).
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 Birmingham, Alabama, United States; Fairhope, Alabama, United States; Mobile, Alabama, United States; Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Fort Smith, Arkansas, United States and 231 more location(s). 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.