Clinical Trials Using Binimetinib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Binimetinib. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 30
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  • Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
    Location: 1200 locations

  • An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

    This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.
    Location: 21 locations

  • Binimetinib in Treating Younger Patients with Progressive or Recurrent Solid Tumors or Low-Grade Gliomas

    This phase I / II trial studies the side effects and best of dose binimetinib and to see how well it works in treating younger patients with solid tumors or low-grade gliomas that are growing, spreading, or getting worse (progressive) or have come back (recurrent). Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 15 locations

  • An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer

    This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mutant metastatic non-small cell lung cancer (NSCLC). Patients who are either treatment-naïve, OR who have received 1) first-line treatment with standard platinum-based chemotherapy, OR 2) first-line treatment with an anti-programmed cell death protein 1 (PD-1) / programmed cell death protein ligand 1 (PD-L1) inhibitor given alone or in combination with platinum-based chemotherapy will be enrolled.
    Location: 14 locations

  • Binimetinib for the Treatment of Neurofibromatosis Type 1 Associated Plexiform Neurofibromas, PNOC010 Study

    This phase II trial investigates how well binimetinib works in treating patients with neurofibromatosis type 1 associated plexiform neurofibromas. Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 12 locations

  • Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651)

    The purpose of this study is to determine safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) for the following combinations: pembrolizumab plus binimetinib (Cohort A), pembrolizumab plus mFOLFOX7 (oxaliplatin 85 mg / m^2; leucovorin [calcium folinate] 400 mg / m^2; fluorouracil [5-FU] 2400 mg / m^2) (Cohort B), pembrolizumab plus mFOLFOX7 and binimetinib (Cohort C), pembrolizumab plus FOLFIRI (irinotecan 180 mg / m^2; leucovorin [calcium folinate]400 mg / m^2; 5-FU 2400 mg / m^2 over 46-48 hours) (Cohort D), and pembrolizumab plus FOLFIRI and binimetinib (Cohort E).
    Location: 8 locations

  • Binimetinib and Encorafenib in Treating Patients with Recurrent BRAF V600-Mutated High-Grade Astrocytoma or Other Primary Brain Tumor

    This phase II trial studies the effect of the combination of binimetinib and encorafenib in treating patients with high-grade astrocytoma or other primary brain tumors that have come back (recurrent) and are positive for BRAF V600 mutations. BRAF V600 mutations are specific changes in the BRAF gene, which makes a protein that is involved in sending signals in cells and in cell growth. BRAF V600 mutations may increase the growth and spread of cancer cells. Binimetinib and encorafenib may be more effective than usual treatment (surgery, radiation or chemotherapy) in stopping the growth of tumor cells by blocking some of the enzymes needed for cell growth in patients with recurrent high-grade astrocytoma or other primary brain tumors that are positive for BRAF V600 mutations.
    Location: 5 locations

  • Early Identification and Treatment of Occult Metastatic Disease in Stage III Colorectal Cancer

    This phase III trial studies how well either FOLFIRI (leucovorin, fluorouracil, and irinotecan), active surveillance, nivolumab, or encorafenib, binimetinib, and cetuximab work in decreasing recurrence (chance of the cancer coming back) in patients with stage III colorectal cancer who are ctDNA positive. If all the cancer is not killed after initial treatment, bloods tests may be able to detect tumor DNA in the blood called circulating tumor DNA (ctDNA). This is genetic material unique to the cancer that may be present in the blood stream and can be identified through a ctDNA blood test. Cancer researchers believe that ctDNA in the blood stream may be an indicator that cancer is more likely to recur. Chemotherapy drugs, such as leucovorin, fluorouracil, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Nivolumab is an anti-PD-1 antibody. It works by attaching to and blocking a molecule called PD-1. PD-1 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus potentially allowing immune cells to recognize and destroy cancer cells. Encorafenib in combination with binimetinib and cetuximab may target the BRAF V600E-mutation in colorectal cancer. When this mutation is present, it switches on pathway called the MAPK pathway which stimulates cell division and leads to uncontrolled cell growth. Encorafenib, binimetinib and cetuximab target different parts of this important signaling pathway in tumor cells with this mutation and may slow down their growth and communication. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. This study is being done to determine whether there are differences in cancer recurrence in ctDNA positive patients treated with additional therapy versus put on active surveillance.
    Location: 5 locations

  • Binimetinib and Palbociclib or TAS-102 in Treating Patients with KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer

    This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer.
    Location: 7 locations

  • Avelumab with Binimetinib, Utomilumab, or anti-OX40 Antibody PF-04518600 in Treating Patients with Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

    This phase II trial studies how well avelumab in combination with binimetinib, utomilumab, or anti-OX40 antibody PF-04518600 works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patients immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. Patients on this trial will receive two weeks of treatment with one of three treatments to stimulate the bodies immune system, including the monoclonal antibodies utomilumab and the anti-OX40 antibody PF-04518600 which may help the body's immune system attack the cancer, and could interfere with the ability of tumor cells to grow and spread. The third medication is called binimetinib , which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with binimetinib, utomilumab, or anti-OX40 antibody PF-04518600 will work better in treating patients with triple negative breast cancer.
    Location: 8 locations

  • Study of IDE196 in Patients With Solid Tumors Harboring GNAQ / 11 Mutations or PRKC Fusions

    This is a Phase 1 / 2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ / 11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 Tablet and Food Effect Pharmacokinetic (PK) Substudy will assess the PK profile of IDE196 tablet and evaluate the effects of food on the PK profile of IDE196 tablet Phase 1 (dose escalation - combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.
    Location: 4 locations

  • Binimetinib and Encorafenib in Treating Patients with Genetically Changed (Non-V600 Activating BRAF Mutant) Metastatic or Advanced Malignant Tumors

    This phase I / II trial studies the best dose and side effects of binimetinib and to see how well it works when given together with encorafenib in treating patients with malignant tumors that have spread to other places in the body (metastatic or advanced) and have a specific type of genetic mutation (non-V600 activating BRAF mutant). BRAF gene makes a protein that is involved in sending signals in cells and in cell growth. BRAF activating mutation may result in constant activation of cellular growth that may increase the growth and spread of cancer cells. Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors

    This Phase 1b / 2 study will examine the effects of the study drugs, avelumab, binimetinib and talazoparib when given in a 2 (doublet) or 3 (triplet) drug combination, in patients with locally advanced or metastatic RAS-mutant solid tumors. The Phase 1b part of the study will assess if the different study drugs can be given together safely and which doses to use for further research. Phase 2 will test if the study treatments have an effect on tumor size and growth, and gather more information about potential side effects.
    Location: 4 locations

  • Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

    This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide / breast cancer resistance protein (OATP / BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase.
    Location: 2 locations

  • Palbociclib with or without Binimetinib or Binimetinib Alone in Treating Patients with Advanced KRAS Mutant Non-small Cell Lung Cancer

    This randomized phase I trial studies the side effects and best dose of palbociclib and binimetinib and to see how well they work in treating patients with KRAS mutant non-small cell lung cancer that has spread to other places in the body. Palbociclib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 2 locations

  • Lorlatinib with Crizotinib or Binimetinib for the Treatment of Refractory Stage IV Non-small Cell Lung Cancer with ALK or ROS1 Gene Rearrangement

    This phase Ib / II trial studies the side effects and best dose of lorlatinib and how well it works with crizotinib or binimetinib in treating patients with stage IV non-small cell lung cancer that has not responded to treatment (refractory) with ALK or ROS1 gene rearrangement. Lorlatinib is an oral ALK and ROS1 inhibitor that may help stop the growth and spread of ALK-positive and ROS1-positive lung cancer cells. Binimetinib is an oral inhibitor of MEK, a signaling protein that may cause some types of lung cancer to grow. Combining binimetinib with drugs targeting these growth signals has been shown to prevent lung cancer cells from growing. Crizotinib is an oral inhibitor of a number of proteins, including MET, a signaling protein that may cause some types of cancer to grow. Adding crizotinib to lorlatinib may be able to control the growth of lung cancer cells that have also become dependent on growth signals from MET. Giving lorlatinib with crizotinib or binimetinib may work better in treating patients with non-small cell lung cancer.
    Location: 2 locations

  • Binimetinib and Hydroxychloroquine in Treating Patients with KRAS Mutant Metastatic Pancreatic Cancer

    This phase I trial studies the best dose of hydroxychloroquine when given together with binimetinib in treating patients with KRAS gene mutated pancreatic cancer that 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. Hydroxychloroquine may prevent autophagy, a normal process in which a cell destroys proteins and other substances which may lead to cell death. Autophagy may prevent normal cells from developing into tumor cells, but it may also protect tumor cells by destroying anticancer drugs or substances taken up by them. Giving hydroxychloroquine together with binimetinib may work better in treating patients with pancreatic cancer compared to binimetinib alone.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Encorafenib, Binimetinib, and Nivolumab in Treating Patients with Microsatellite Stable BRAFV600E Metastatic Colorectal Cancer

    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.
    Location: 2 locations

  • Brigatinib and Binimetinib in Treating Patients with Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer

    This phase I trial studies the side effects and best dose of brigatinib and binimetinib in treating patients with stage IIIB-IV non-small cell lung cancer and a type of gene mutation called a rearrangement in the ALK or ROS1 genes. Brigatinib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Pembrolizumab, Binimetinib, and Bevacizumab in Treating Participant with Metastatic Unresectable Colorectal Cancer

    This phase II trial studies how well pembrolizumab, binimetinib, and bevacizumab work in treating participants with colorectal cancer that has spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab, binimetinib, and bevacizumab may work better in treating participants with colorectal cancer.
    Location: University of Colorado Hospital, Aurora, Colorado

  • Nivolumab with Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients with BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

    This phase II trial studies the side effects and how well nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib work in treating patients with BRAF-mutated stage III-IV melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Trametinib, dabrafenib, encorafenib, and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib may work better in treating patients with BRAF-mutated melanoma.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Combination Chemotherapy and Binimetinib in Treating Patients with RAS Positive Metastatic Colorectal Cancer

    This phase Ib trial studies the side effects and best doses of combination chemotherapy when given together with binimetinib in patients with RAS positive colorectal cancer that has spread from the primary site (place where it started) to other places in the body (metastatic). Drugs used in chemotherapy, such as fluorouracil and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Binimetinib works in different ways to stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with binimetinib may kill more tumor cells.
    Location: Huntsman Cancer Institute / University of Utah, Salt Lake City, Utah

  • Binimetinib and Imatinib Mesylate in Treating Patients with Untreated Advanced Gastrointestinal Stromal Tumors

    This phase Ib / II trial studies the side effects and the best dose of binimetinib when given together with imatinib mesylate and to see how well they work in treating patients with untreated gastrointestinal stromal tumors that have spread from where they started to nearby tissue or lymph nodes or to other places in the body (advanced). Binimetinib and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Encorafenib Plus Binimetinib for People With BRAF V600E Mutated Relapsed / Refractory HCL

    Background: Hairy cell leukemia (HCL) does not usually respond to chemotherapy. Most people with HCL have a BRAF gene mutation. This can increase the growth of cancer cells. Vemurafenib has been tested to treat these people. However, researchers think a combination of drugs might work better. Objective: To test if treatment with a combination of encorafenib and binimetinib in BRAF mutant HCL is more effective than treatment with vemurafenib. Eligibility: People ages 18 and older with BRAF mutant HCL that did not respond to or came back after treatment Design: Participants will be screened with: Medical history Physical exam Bone marrow biopsy: A needle will be injected through the participant s skin and into a bone to remove liquid. Blood and urine tests Heart and lung function tests CT or MRI scan: Participants will lie in a machine that takes pictures of the body. They may have a contrast agent injected into a vein. Eye exam Participants will take the study drugs by mouth in 28-day cycles. They will take encorafenib daily. They will take binimetinib twice daily. They will keep a pill diary. Participants will take their temperature daily. Participants will have at least 1 visit before each cycle. Visits will include repeats of some screening tests. They will also include abdominal ultrasounds, exercise stress tests, and skin evaluations. Participants may continue treatment as long as their disease does not get worse and they do not have bad side effects. About a month after their last dose of treatment, participants will have a follow-up visit. Then they will have annual follow-ups....
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Binimetinib for People With Relapsed / Refractory BRAF Wild Type Hairy Cell Leukemia and Variant

    Background: Most people with hairy cell leukemia have a BRAF gene mutation. They can be treated with BRAF inhibitors, drugs that target this mutation. For people who do not have this mutation, BRAF inhibitors are not a treatment option. We found that in hairy cell leukemia, when BRAF is not mutated, the MEK gene frequently is. Binimetinib is a MEK inhibitor which targets MEK. It is important to determine if this drug can be a good treatment option in those who cannot benefit treatment with BRAF inhibitors. Objective: To see if binimetinib is an effective treatment for hairy cell leukemia that does not have a BRAF mutation. Eligibility: People ages 18 and older with hairy cell leukemia without a mutation in the BRAF gene and whose disease either did not respond to treatment or came back after treatment Design: Participants will be screened with: - Medical history - Physical exam - Blood and urine tests - Lung and heart tests - Eye exam - Bone marrow biopsy: A needle will be injected through the participant s skin into the bone to remove a sample of marrow. - CT or MRI scan: Participants will lie in a machine that takes pictures of the body. They might receive a contrast agent by vein. Before they start treatment, participants will have an abdominal ultrasound, pulmonary function tests, and exercise stress tests. Participants will take binimetinib by mouth twice daily in 28-day cycles. They will keep a medication diary. Participants will have at least one visit before every cycle. Visits will include repeats of some screening tests. Participants may continue treatment as long as their disease does not get worse and they do not have bad side effects. About a month after their last dose of treatment, participants will have a follow-up visit. They will then have visits once a year. ...
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland


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