Binimetinib
Information
- Drug Name
- Binimetinib
- Description
- Entry(CIViC)
- 9
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| neuroblastoma |
NRAS p.Gln61Lys (p.Q61K) ( ENST00000369535.5 ) NRAS p.Gln61Lys (p.Q61K) ( ENST00000369535.5 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 26821351 | Detail |
| skin melanoma | NRAS Q61 NRAS Q61 | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 2 | 23414587 | Detail |
| skin melanoma | NRAS MUTATION NRAS MUTATION | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 2 | 23414587 | Detail |
| melanoma | NRAS MUTATION NRAS MUTATION | D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 24588908 | Detail |
| skin melanoma | NRAS MUTATION NRAS MUTATION | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 26987942 | Detail |
| skin melanoma | NRAS MUTATION NRAS MUTATION | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 5 | 28284557 | Detail |
| colorectal cancer | KRAS MUTATION KRAS MUTATION | D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 27167191 | Detail |
| cancer | HRAS MUTATION HRAS MUTATION | D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 26544513 | Detail |
| melanoma | BRAF V600 BRAF V600 | A |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 5 | 29573941 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In-vitro study in 5 neuroblastoma cell lines (2 wi... | NRAS |
NRAS p.Gln61Lys (p.Q61K) ( ENST00000369535.5 ) NRAS p.Gln61Lys (p.Q61K) ( ENST00000369535.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Phase 2 study of MEK162 in patients with advanced ... | NRAS | NRAS Q61 NRAS Q61 | Sensitivity | true | CIViC Evidence | detail |
| Phase II study in 71 patients with NRAS or BRAF V6... | NRAS | NRAS MUTATION NRAS MUTATION | Sensitivity | true | CIViC Evidence | detail |
| In a panel of 7 NRAS mutant melanoma cell lines, a... | NRAS | NRAS MUTATION NRAS MUTATION | Sensitivity | true | CIViC Evidence | detail |
| Inhibition of CDK4 and 6, regulators of the G1/S c... | NRAS | NRAS MUTATION NRAS MUTATION | Sensitivity | true | CIViC Evidence | detail |
| NEMO is an ongoing, randomised, open-label phase 3... | NRAS | NRAS MUTATION NRAS MUTATION | Sensitivity | true | CIViC Evidence | detail |
| A preclinical study to investigate the efficacy of... | KRAS | KRAS MUTATION KRAS MUTATION | Sensitivity | true | CIViC Evidence | detail |
| A pre-clinical study in 10 solid cancer cell lines... | HRAS | HRAS MUTATION HRAS MUTATION | Sensitivity | true | CIViC Evidence | detail |
| In a phase 3 trial, patients with melanoma with BR... | BRAF | BRAF V600 BRAF V600 | Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT04221438 | Active, not recruiting | Phase 2 | Testing Treatment With Encorafenib and Binimetinib Before Surgery for Melanoma With Lymph Node Involvement | September 22, 2021 | February 28, 2025 |
| NCT04657991 | Active, not recruiting | Phase 3 | A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma | January 15, 2021 | June 30, 2026 |
| NCT04439344 | Active, not recruiting | Phase 2 | Testing Binimetinib as a Potential Targeted Treatment in Cancers With NRAS Genetic Changes (MATCH-Subprotocol Z1A) | May 31, 2016 | March 5, 2025 |
| NCT03981614 | Active, not recruiting | Phase 2 | Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer | October 29, 2019 | April 3, 2024 |
| NCT03839342 | Active, not recruiting | Phase 2 | Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations | June 7, 2019 | December 2024 |
| NCT03170206 | Active, not recruiting | Phase 1 | Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer | May 31, 2017 | June 30, 2025 |
| NCT03864042 | Active, not recruiting | Phase 1 | Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors | January 2, 2018 | June 30, 2023 |
| NCT05195632 | Active, not recruiting | Phase 2 | Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer | June 2, 2022 | May 2025 |
| NCT03898908 | Active, not recruiting | Phase 2 | Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain | July 18, 2019 | October 10, 2023 |
| NCT04800822 | Active, not recruiting | Phase 1 | PF-07284892 in Participants With Advanced Solid Tumors | March 17, 2021 | November 29, 2025 |
| NCT03915951 | Active, not recruiting | Phase 2 | An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer | June 4, 2019 | October 1, 2024 |
| NCT02465060 | Active, not recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | August 17, 2015 | December 31, 2025 |
| NCT03231306 | Active, not recruiting | Phase 2 | Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas | November 28, 2017 | December 31, 2026 |
| NCT02910700 | Active, not recruiting | Phase 2 | Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma | December 9, 2016 | December 8, 2024 |
| NCT04585815 | Active, not recruiting | Phase 1/Phase 2 | Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) | November 10, 2020 | June 17, 2024 |
| NCT03475004 | Active, not recruiting | Phase 2 | Study of Pembrolizumab, Binimetinib, and Bevacizumab in Patients With Refractory Colorectal Cancer | September 17, 2018 | December 31, 2024 |
| NCT02510001 | Completed | Phase 1 | MEK and MET Inhibition in Colorectal Cancer | November 2014 | December 3, 2018 |
| NCT02834364 | Completed | Phase 2 | BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA) | June 2016 | March 29, 2023 |
| NCT02902042 | Completed | Phase 1/Phase 2 | Encorafenib + Binimetinib + Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma | April 24, 2018 | November 30, 2020 |
| NCT02928224 | Completed | Phase 3 | Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer | October 13, 2016 | November 10, 2022 |
| NCT02964689 | Completed | Phase 1 | Binimetinib in Addition to Standard Chemotherapy in KRAS Mutated NSCLC. | April 12, 2017 | July 2, 2021 |
| NCT03106415 | Completed | Phase 1/Phase 2 | Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer | September 27, 2017 | May 19, 2022 |
| NCT03271047 | Completed | Phase 2 | Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation | October 18, 2017 | February 25, 2021 |
| NCT03374254 | Completed | Phase 1 | 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) | February 16, 2018 | July 18, 2023 |
| NCT02185690 | Completed | Phase 1 | A Phase I/Ib Study of MEK162, a MEK Inhibitor, in Combination With Carboplatin and Pemetrexed in Patients With Non-squamous Carcinoma of the Lung | January 11, 2018 | July 4, 2019 |
| NCT05260684 | Completed | Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US | January 17, 2022 | December 31, 2023 | |
| NCT03693170 | Completed | Phase 2 | Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer | January 17, 2019 | April 27, 2023 |
| NCT03843775 | Completed | Phase 1/Phase 2 | A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers | February 14, 2019 | September 2, 2023 |
| NCT05304546 | Not yet recruiting | Phase 2 | Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma | June 2023 | June 2027 |
| NCT05926960 | Recruiting | Phase 2 | A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma | June 13, 2023 | May 23, 2027 |
| NCT03543969 | Recruiting | Early Phase 1 | Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma | June 14, 2018 | July 2028 |
| NCT03563729 | Recruiting | Phase 2 | Melanoma Metastasized to the Brain and Steroids | June 6, 2018 | June 6, 2028 |
| NCT03947385 | Recruiting | Phase 1/Phase 2 | Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions | June 28, 2019 | May 31, 2025 |
| NCT03971409 | Recruiting | Phase 2 | Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer | July 8, 2019 | June 30, 2025 |
| NCT03991819 | Recruiting | Phase 1 | Study of Binimetinib in Combination With Pembrolizumab in Advanced Non-Small Cell Lung Cancer | September 20, 2019 | December 2026 |
| NCT04045691 | Recruiting | Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment | October 17, 2019 | September 2027 | |
| NCT04061980 | Recruiting | Phase 2 | Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer | October 30, 2020 | October 30, 2026 |
| NCT04132505 | Recruiting | Phase 1 | Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer | October 22, 2019 | December 31, 2026 |
| NCT04511013 | Recruiting | Phase 2 | A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases | January 6, 2021 | June 30, 2027 |
| NCT04598009 | Recruiting | Phase 2 | Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma | March 3, 2021 | March 31, 2026 |
| NCT04720768 | Recruiting | Phase 1/Phase 2 | Encorafenib, Binimetinib and Palbociclib in BRAF-mutant Metastatic Melanoma CELEBRATE | June 4, 2020 | December 4, 2024 |
| NCT04720976 | Recruiting | Phase 1/Phase 2 | JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors | March 23, 2021 | February 5, 2024 |
| NCT04892017 | Recruiting | Phase 1/Phase 2 | A Phase 1/2 Study of DCC-3116 in Patients With RAS/MAPK Pathway Mutant Solid Tumors | June 15, 2021 | August 2028 |
| NCT05026983 | Recruiting | Phase 2 | Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases | December 27, 2021 | May 1, 2025 |
| NCT05111561 | Recruiting | Phase 1 | Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer | August 2, 2022 | March 14, 2025 |
| NCT05170334 | Recruiting | Phase 2 | Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma | December 15, 2021 | December 2024 |
| NCT05355701 | Recruiting | Phase 1 | A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. | July 5, 2022 | March 5, 2029 |
| NCT05510895 | Recruiting | Phase 2 | Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer | September 1, 2022 | January 31, 2025 |
| NCT05554354 | Recruiting | Phase 2 | Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial) | August 27, 2024 | November 1, 2026 |
| NCT05554367 | Recruiting | Phase 2 | Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial | December 13, 2023 | August 26, 2026 |
| NCT05564377 | Recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial | April 7, 2023 | July 1, 2030 |
| NCT05564403 | Recruiting | Phase 2 | Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) | February 9, 2024 | January 21, 2025 |
| NCT05615818 | Recruiting | Phase 3 | Personalized Medicine for Advanced Biliary Cancer Patients | May 29, 2024 | June 2028 |
| NCT04322383 | Recruiting | Phase 2 | Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant | January 7, 2021 | July 31, 2028 |
| NCT04324112 | Recruiting | Phase 2 | Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL | October 28, 2020 | July 31, 2028 |
| NCT04375527 | Recruiting | Phase 2 | Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma | December 3, 2020 | June 1, 2025 |
| NCT03911869 | Terminated | Phase 2 | 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 | April 30, 2019 | January 27, 2022 |
| NCT04801966 | Terminated | N/A | Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study | September 23, 2021 | December 30, 2022 |
| NCT03637491 | Terminated | Phase 1/Phase 2 | A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors | August 15, 2018 | February 2, 2021 |
| NCT04543188 | Terminated | Phase 1 | A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement | January 8, 2021 | March 20, 2024 |
| NCT04005144 | Terminated | Phase 1 | Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer | February 25, 2020 | October 1, 2022 |
| NCT04655157 | Terminated | Phase 1/Phase 2 | Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma | May 28, 2021 | September 20, 2022 |
| NCT03973918 | Terminated | Phase 2 | Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG | July 29, 2019 | October 1, 2023 |
| NCT03878719 | Terminated | Phase 1 | Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma | August 3, 2020 | August 19, 2022 |
| NCT04390243 | Terminated | Phase 2 | Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation | November 16, 2020 | November 1, 2023 |
| NCT04044430 | Terminated | Phase 1 | Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer | August 31, 2020 | July 31, 2022 |
| NCT04292119 | Unknown status | Phase 1/Phase 2 | Lorlatinib Combinations in Lung Cancer | May 1, 2020 | March 1, 2023 |
| NCT04870034 | Withdrawn | Early Phase 1 | Binimetinib and Palbociclib Before Surgery for the Treatment of Operable KRAS-Positive Lung, Colorectal, or Pancreatic Cancer | January 15, 2024 | September 30, 2026 |
| NCT02451865 | Withdrawn | Phase 1 | Binimetinib With Docetaxel in Treating Patients With Previously Treated, Stage IV Non-small Cell Lung Cancer | June 2016 | June 2019 |
| NCT05080621 | Withdrawn | Phase 1/Phase 2 | Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST) | November 2021 | May 2027 |
| NCT02263898 | Withdrawn | Phase 2 | Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations | January 2015 | December 2020 |