Cobimetinib

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Information
Drug Name
Cobimetinib
Description
Entry(CIViC)
5
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
cancer BRAF p.Val640Glu (p.V640E)
( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E)
( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) 		D Predictive Supports Sensitivity/Response Somatic 3 23934108 Detail
melanoma BRAF p.Val640Glu (p.V640E)
( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E)
( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) 		B Predictive Supports Sensitivity/Response Somatic 4 25265494 Detail
melanoma BRAF V600 BRAF V600 B Predictive Supports Sensitivity/Response Somatic 4 25265494 Detail
melanoma BRAF V600 BRAF V600 A Predictive Supports Sensitivity/Response Somatic 5 27480103 Detail
melanoma BRAF V600 BRAF V600 B Predictive Supports Sensitivity/Response Somatic 3 25037139 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
Preclinical study analyzing the differential respo... BRAF BRAF p.Val640Glu (p.V640E)
( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E)
( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) 		Sensitivity true CIViC Evidence detail
In this Phase III trial (coBRIM, NCT01689519) of 4... BRAF BRAF p.Val640Glu (p.V640E)
( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) BRAF p.Val640Glu (p.V640E)
( ENST00000288602.11, ENST00000496384.7, ENST00000644969.2, ENST00000646891.2 ) 		Sensitivity true CIViC Evidence detail
In a randomized phase 3 study, previously untreate... BRAF BRAF V600 BRAF V600 Sensitivity true CIViC Evidence detail
In this double-blind, randomized, placebo-controll... BRAF BRAF V600 BRAF V600 Sensitivity true CIViC Evidence detail
In this Phase 1b study, 129 patients with unresect... BRAF BRAF V600 BRAF V600 Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT02036086 Active, not recruiting Phase 2 Study of Neo-adjuvant Use of Vemurafenib Plus Cobimetinib for BRAF Mutant Melanoma With Palpable Lymph Node Metastases August 2015 January 31, 2024
NCT02060188 Active, not recruiting Phase 2 A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread March 12, 2014 June 28, 2024
NCT04931342 Active, not recruiting Phase 2 A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors October 7, 2021 December 31, 2028
NCT02721459 Active, not recruiting Phase 1 XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma September 7, 2016 October 2024
NCT04941287 Active, not recruiting Phase 2 Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer December 15, 2021 September 1, 2024
NCT04214418 Active, not recruiting Phase 1/Phase 2 Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies February 12, 2020 September 2024
NCT03337698 Active, not recruiting Phase 1/Phase 2 A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) January 2, 2018 November 30, 2026
NCT04591431 Active, not recruiting Phase 2 The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy October 7, 2020 June 2025
NCT04835805 Active, not recruiting Phase 1 A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma. May 13, 2021 November 28, 2025
NCT02908672 Active, not recruiting Phase 3 A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma January 13, 2017 May 15, 2024
NCT03101254 Active, not recruiting Phase 1/Phase 2 LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma June 6, 2017 December 31, 2023
NCT03600701 Active, not recruiting Phase 2 Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer November 29, 2018 July 17, 2024
NCT03498521 Active, not recruiting Phase 2 A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site July 10, 2018 June 9, 2024
NCT03175432 Active, not recruiting Phase 2 Bevacizumab and Atezolizumab With or Without Cobimetinib in Treating Patients With Untreated Melanoma Brain Metastases June 15, 2017 June 30, 2026
NCT03281369 Active, not recruiting Phase 1/Phase 2 A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) October 13, 2017 April 30, 2025
NCT03363867 Active, not recruiting Phase 2 BEACON - ABC in Recurrent Platinum Resistant HGSOC July 10, 2018 June 30, 2025
NCT03181100 Active, not recruiting Phase 2 Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer July 27, 2017 July 31, 2025
NCT03193190 Active, not recruiting Phase 1/Phase 2 A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) July 5, 2017 October 31, 2026
NCT01928394 Active, not recruiting Phase 1/Phase 2 A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors October 24, 2013 October 31, 2024
NCT03202316 Active, not recruiting Phase 2 Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer August 11, 2017 December 31, 2024
NCT03202940 Active, not recruiting Phase 1/Phase 2 A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC September 14, 2017 January 1, 2027
NCT03224767 Active, not recruiting Phase 2 Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma August 4, 2017 August 2026
NCT02902029 Completed Phase 2 Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma November 2016 March 2024
NCT03108131 Completed Phase 2 Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors April 7, 2017 April 2, 2024
NCT03139513 Completed A Study of Adult Participants With BRAF V600 Mutation-Positive Advanced Melanoma Treated With Cobimetinib (Cotellic®) During the French Early Access Program (Temporary Authorization for Use [TAU]) October 27, 2016 August 22, 2018
NCT03178851 Completed Phase 1 Cobimetinib (Targeted Therapy) Plus Atezolizumab (Immunotherapy) in Participants With Advanced Melanoma Whose Cancer Has Worsened During or After Treatment With Previous Immunotherapy and Atezolizumab Monotherapy in Participants With Previously Untreated Advanced Melanoma June 20, 2017 September 21, 2020
NCT03201458 Completed Phase 2 Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer February 8, 2018 February 19, 2024
NCT04007848 Completed Phase 3 Cobimetinib for BRAF-wild-type or Mutated Histiocytoses July 25, 2019 March 14, 2022
NCT01249131 Completed Phase 1 A Study of Relative Bioavailability and Food Effect Study of Cobimetinib in Healthy Participants December 1, 2010 January 10, 2011
NCT01271803 Completed Phase 1 A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma February 17, 2011 December 12, 2017
NCT01277718 Completed Phase 1 A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants January 2011 February 2011
NCT01562275 Completed Phase 1 A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors April 2012 January 2015
NCT01656642 Completed Phase 1 A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma August 13, 2012 March 25, 2020
NCT01689519 Completed Phase 3 A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma January 8, 2013 July 21, 2019
NCT01929876 Completed Phase 1 A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants July 2013 October 2013
NCT01959633 Completed Phase 1/Phase 2 Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF Mutation April 3, 2014 March 26, 2018
NCT01986166 Completed Phase 1 A Study of MEHD7945A and Cobimetinib in Patients With Locally Advanced or Metastatic Cancers With Mutant KRAS November 2013 January 2016
NCT01988896 Completed Phase 1 Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors December 27, 2013 November 4, 2019
NCT02091141 Completed Phase 2 My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors April 14, 2014 May 24, 2023
NCT02136524 Completed Phase 1 A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation April 2014 May 2014
NCT02291289 Completed Phase 2 A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) April 17, 2015 March 24, 2021
NCT02300025 Completed Phase 1 A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage August 2014 January 2015
NCT02457793 Completed Phase 1 A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors June 16, 2015 December 5, 2016
NCT02639546 Completed Phase 1/Phase 2 Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors May 20, 2016 July 21, 2021
NCT02649972 Completed Phase 2 Single-agent Cobimetinib for Adults With Histiocytic Disorders January 2016 December 16, 2022
NCT02670044 Completed Phase 1 A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy March 9, 2016 December 10, 2020
NCT02768207 Completed Phase 2 A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma May 23, 2016 June 27, 2019
NCT02788279 Completed Phase 3 A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370) July 5, 2016 December 26, 2018
NCT02876224 Completed Phase 1 Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors September 30, 2016 June 25, 2019
NCT03264066 Completed Phase 2 A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors November 23, 2017 June 25, 2020
NCT03312530 Completed Phase 1/Phase 2 A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma November 13, 2017 May 18, 2021
NCT03395899 Completed Phase 2 Pre-operative Immunotherapy Combination Strategies in Breast Cancer December 21, 2017 August 18, 2023
NCT03625141 Completed Phase 2 A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases December 13, 2018 April 13, 2023
NCT03695380 Completed Phase 1 A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer January 9, 2019 July 12, 2023
NCT03989115 Completed Phase 1/Phase 2 Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC July 2, 2019 February 8, 2022
NCT00467779 Completed Phase 1 Study of Cobimetinib in Participants With Solid Tumors May 2007 April 2014
NCT05260684 Completed Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US January 17, 2022 December 31, 2023
NCT03178552 Recruiting Phase 2/Phase 3 A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) September 22, 2017 August 3, 2028
NCT05441514 Recruiting Phase 1 Enasidenib in Combination With Cobimetinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia November 3, 2022 May 2, 2025
NCT03768063 Recruiting Phase 3 A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study February 28, 2019 July 5, 2028
NCT05691504 Recruiting Phase 1 Testing the Combination of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers September 14, 2023 June 1, 2026
NCT04005690 Recruiting Early Phase 1 Targeted Pathway Inhibition in Patients With Pancreatic Cancer August 1, 2019 February 1, 2028
NCT05768178 Recruiting Phase 2/Phase 3 DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers. March 1, 2023 October 2029
NCT04079179 Recruiting Phase 2 Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders April 19, 2021 December 2029
NCT04109456 Recruiting Phase 1 IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma March 16, 2020 September 30, 2024
NCT04185831 Recruiting Phase 2 A MolEcularly Guided Anti-Cancer Drug Off-Label Trial October 20, 2020 October 2024
NCT04216953 Recruiting Phase 1/Phase 2 MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma February 12, 2020 February 1, 2027
NCT04409639 Recruiting Phase 2 Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations January 12, 2021 August 15, 2026
NCT04551521 Recruiting Phase 2 CRAFT: The NCT-PMO-1602 Phase II Trial October 13, 2021 June 30, 2025
NCT05034627 Recruiting Phase 1 Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer August 9, 2022 October 1, 2026
NCT05125471 Recruiting Phase 2 Cobimetinib In Extracranial Arteriovenous Malformations (COBI-AVM Study) July 26, 2022 December 2026
NCT05159245 Recruiting Phase 2 The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs December 10, 2021 November 25, 2026
NCT03554083 Recruiting Phase 2 Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma October 5, 2018 June 29, 2025
NCT06440850 Recruiting Phase 2 Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation November 30, 2024 November 30, 2026
NCT02818023 Terminated Phase 1 Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma July 13, 2016 April 23, 2021
NCT02322814 Terminated Phase 2 A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread March 12, 2015 September 17, 2021
NCT01495988 Terminated Phase 2 Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma August 2013 June 2016
NCT03566485 Terminated Phase 1/Phase 2 Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer July 10, 2018 December 10, 2020
NCT02303951 Terminated Phase 2 Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC January 22, 2015 May 14, 2020
NCT04190628 Terminated Phase 1 Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors June 16, 2020 April 5, 2024
NCT02230306 Terminated Phase 2 Phase II Study of Cobimetinib in Combination With Vemurafenib in Active Melanoma Brain Metastases February 2015 March 2016
NCT00996892 Terminated Phase 1 Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors November 2009 March 2014
NCT03878524 Terminated Phase 1 Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial April 1, 2020 December 10, 2020
NCT03273153 Terminated Phase 3 A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma December 11, 2017 February 19, 2021
NCT03224208 Terminated Phase 2 Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients May 17, 2018 January 8, 2021
NCT03430947 Terminated Phase 2 Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases July 1, 2018 February 10, 2023
NCT04801966 Terminated N/A Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study September 23, 2021 December 30, 2022
NCT01813214 Terminated Phase 2 The Effects of Vemurafenib + Cobimetinib on Immunity in Patients With Melanoma March 2013 December 2016
NCT02427893 Withdrawn Phase 3 Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma August 2015 November 2016
NCT01974258 Withdrawn Phase 1 Safety, Tolerability, and Pharmacokinetics of Onartuzumab Combined With Vemurafenib and/or Cobimetinib in Cancer Patients February 2014 July 2014
NCT03340558 Withdrawn Phase 2 Atezolizumab Monotherapy vs Atezolizumab Plus Cobimetinib in Liver Metastases From Colorectal Cancer May 2018 February 2025
NCT05238831 Withdrawn Early Phase 1 SMMART Adaptive Clinical Treatment (ACT) Trial January 30, 2023 May 31, 2026