A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
Launched by SWOG CANCER RESEARCH NETWORK · Aug 10, 2020
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is designed to compare two different treatment combinations for patients with a specific type of melanoma called BRAF-V600 mutant melanoma, which has spread to the brain. The study is looking at the effectiveness of a combination of three drugs—encorafenib, binimetinib, and nivolumab—against another combination of two drugs—ipilimumab and nivolumab. Both combinations aim to control and reduce brain tumors caused by melanoma.
To participate in this trial, individuals must have confirmed melanoma that has spread to the brain and must meet specific health criteria, such as having a measurable brain tumor size and being able to take pills. Participants will undergo regular check-ups and imaging tests to monitor their condition. Importantly, the trial is currently recruiting patients of various ages and backgrounds, and those interested will need to give their consent to participate in this research study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 in size (per modified RECIST 1.1) that has not been irradiated, or progressed (in the opinion of the treating physician) after prior radiation therapy. Participating sites MUST use MRI slice thickness of =\< 1.5 mm and are recommended to adhere to the 'minimum' Brain Tumor Imaging Protocol for Clinical Trials in Brain Metastases (BTIP-BM) compliant MRI acquisition protocol. Computed tomography (CT) of the head cannot substitute for brain MRI. (NOTE: All central nervous system \[CNS\] disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form \[RECIST 1.1\] using RECIST 1.1.)
- • 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 randomization. Please note, while any extracranial disease will also be assessed and followed, participants are NOT required to have extracranial disease for randomization. NOTE: All disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). CNS disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form (RECIST 1.1) using RECIST 1.1
- • 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 Functional Classification. To be eligible for this trial, participants must be class 2B or better
- • 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 efficacy assessment of the investigational regimen are eligible for this trial
- • 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 90 days prior to randomization
- • 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 randomization
- • 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 entered in the system
- Exclusion Criteria:
- • 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 anti-CTLA4 therapy, alfa-interferon, etc.) is permitted. If patients received prior neoadjuvant/adjuvant therapy, they must have had eventual disease relapse prior to randomization
- • 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 modifying agents (e.g. methotrexate) or patients on corticosteroids =\< 10 mg prednisone daily or equivalent (to treat auto-immune disease), or on replacement therapy (e.g., thyroxine, insulin) are eligible if deemed in the best interest of the patient by treating physician
- • 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 drugs.)
- • 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 encorafenib can result in decreased concentration and loss of efficacy.) A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
About Swog Cancer Research Network
The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Washington, Missouri, United States
Denver, Colorado, United States
Plantation, Florida, United States
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Tampa, Florida, United States
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Santa Rosa, California, United States
Englewood, Colorado, United States
Tampa, Florida, United States
Burnsville, Minnesota, United States
Lincoln, Nebraska, United States
Aventura, Florida, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Kalamazoo, Michigan, United States
Clemmons, North Carolina, United States
Statesville, North Carolina, United States
Dublin, Ohio, United States
Wilkesboro, North Carolina, United States
Napa, California, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Grove City, Ohio, United States
Centralia, Illinois, United States
Paducah, Kentucky, United States
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New Albany, Ohio, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Ames, Iowa, United States
Patients applied
Trial Officials
Zeynep Eroglu
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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