MEK inhibitor · small molecule
cobimetinib
10 active trials across 11 of our biomarkers, targeting MEK1/2. 4 active approvals for a biomarker on marked.bio.
Also known as GDC-0973, XL518, Cotellic.
Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.
Approvals and pivotal results
Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.
| Therapy | Biomarker | Tumour | United States | European Union |
|---|---|---|---|---|
atezolizumab with cobimetinib + vemurafenib
|
BRAF V600E | melanoma | Approved 2020 | Not approved |
IMspire150
vs placebo + cobimetinib + vemurafenib, 514 randomised
Trial details and side effects
|
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cobimetinib with vemurafenib |
BRAF V600E | melanoma | Approved 2015 | Approved 2015 |
In the US label
coBRIM
vs placebo + vemurafenib, 247 vs 248 patients Stopped for side effects 15% Trial details and side effects
In the EU product information
coBRIM
vs placebo + vemurafenib, 247 vs 248 patients Trial details and side effects
|
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Biomarkers
| Biomarker | Active trials | All trials | Furthest active phase |
|---|---|---|---|
| BRAF V600E | 8 | 35 | Phase 2/3 |
| ALK fusion | 2 | 4 | Phase 2 |
| KRAS G12C | 2 | 8 | Phase 2 |
| KRAS G12D | 1 | 7 | Phase 2 |
| NTRK1/2/3 fusion | 1 | 2 | Phase 2 |
| RET fusion or mutation | 1 | 2 | Phase 2 |
| ROS1 fusion | 1 | 1 | Phase 2 |
| BRCA1/2 mutation | 0 | 1 | – |
| EGFR exon 19 deletion / L858R | 0 | 1 | – |
| MSI-H / dMMR | 0 | 3 | – |
| PIK3CA activating mutation | 0 | 1 | – |
Sponsors
Industry sponsors leading active biomarker-selected trials of cobimetinib.
- Roche 1
Trials
10 of 42 trials shown
-
DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.
vemurafenib FDA EUcobimetinib FDA EU
Confirmed diagnosis of a malignancy harbouring any actionable BRAF V600 mutation using an analytically validated next-generation sequencing method.
BRAF V600EHaematological Malignancy, Melanoma, Thyroid Cancer, Papillary, Ovarian Neoplasms
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Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation
cobimetinib FDA EURecombinant Thyrotropin Alfavemurafenib FDA EU
Known positive BRAFV600E mutation (determined on a previous analysis and/or on a representative formalin-fixed par…
BRAF V600EThyroid Gland Follicular Carcinoma, Thyroid Gland Oncocytic Carcinoma, Thyroid Gland Papillary Carcinoma
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A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
alectinibentrectinibvemurafenibcobimetinibpralsetinibatezolizumabSBRTChemotherapydivarasib
…on in ≥ 1% tumor cells as determined by Food and Drug Administration (FDA)-approved test, KRAS G12C mutation
KRAS G12CBRAF V600EALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionNon-small Cell Lung Cancer
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Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma
cobimetinib FDA EUvemurafenib FDA EUatezolizumab FDA
…urafenib, cobImetinib, and atezolizuMab in Patients With High-risk, Surgically Resectable BRAF Mutated and Wild-type Melanoma"
BRAF V600EMelanoma
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Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer
Presence of a mutation in KRAS as detected by a Clinical Laboratory Improvement Act (CLIA)-approved assay is required fo…
KRAS G12CKRAS G12DMetastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Refractory Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
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Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
vemurafenib FDA EUcobimetinib FDA EU
Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
BRAF V600EBRAF V600E Mutation Present, Papillary Craniopharyngioma
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Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer
atezolizumab FDAbevacizumabcobimetinib FDA EUnab-paclitaxelpaclitaxelvemurafenib FDA EU
ADDITIONAL INCLUSION CRITERIA FOR BRAF MUTATION (COHORT 1): Patients with a BRAFV600E mutation being considered for the triplet combination (vemurafenib + cobimetinib + atezol…
BRAF V600EMetastatic Thyroid Gland Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v8, Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8
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Bevacizumab and Atezolizumab With or Without Cobimetinib in Treating Patients With Untreated Melanoma Brain Metastases
atezolizumab FDAbevacizumabcobimetinib FDA EU
Patients that are known to have BRAFV600 mutation must have received prior BRAFi/MEKi prior to enrolling on TACo.
BRAF V600EBRAF V600 Wild Type, Clinical Stage IV Cutaneous Melanoma AJCC v8, Intracranial Melanoma, Metastatic Malignant Neoplasm in the Brain
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A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC
alectinib FDA EUcobimetinib
…tologically confirmed diagnosis of metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved fluorescence in-situ hy…
ALK fusionNon-small Cell Lung Cancer
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XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma
XL888vemurafenib FDA EUcobimetinib FDA EU
Must have cytologically or histologically-confirmed unresectable melanoma that harbors a BRAF V600 mutation determined by pyrosequencing assay or equivalent genotyping assay in a Clinical …
BRAF V600EMelanoma, Skin Cancer
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Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma
cobimetinib FDA EUvemurafenib FDA EU
Histological diagnosis of unresectable AJCC stage III or stage IV, BRAFV600E/K mutant melanoma
BRAF V600EMelanoma
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A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma
vemurafenib FDA EUcobimetinib FDA EU
… in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test
BRAF V600EMalignant Melanoma
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T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma
BRAF V600E/V600K mutation-positive (applied to part 1 and part 2 cohort 1) or RAS mutation-positive (applied to part 1 and part 2 cohort 2).
KRAS G12CKRAS G12DBRAF V600EMelanoma, Malignant Melanoma
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CRAFT: The NCT-PMO-1602 Phase II Trial
vemurafenib FDA EUcobimetinib FDA EUatezolizumab FDAtrastuzumabpertuzumabalectinibipatasertibinavolisib
Arm 1 (BRAF V600E/K): BRAF V600E/K mutation
BRAF V600EPIK3CA activating mutationALK fusionRET fusion or mutationMSI-H / dMMRMetastatic or Locally Advanced Malignancies
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Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies
cobimetinibhydroxychloroquineatezolizumab
…une Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies
KRAS G12CKRAS G12DNTRK1/2/3 fusionMSI-H / dMMRGastrointestinal Cancer
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Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC
vociprotafibcobimetinibosimertinib FDA EU
For RMC-4630 + Osimertinib only - Locally advanced or metastatic EGFR mutant NSCLC not amenable to curative surgery or radiotherapy
EGFR exon 19 deletion / L858RKRAS G12CKRAS G12DSolid Tumor
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Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases
vemurafenib FDA EUcobimetinib FDA EU
Histologically confirmed metastatic melanoma (stage IV, per AJCC staging), carrying BRAF V600-mutation
BRAF V600EMalignant Melanoma Stage IV, BRAF V600 Mutation, Brain Metastases
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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
cobimetinib FDA EUatezolizumab FDAvemurafenib FDA EU
…th Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases
BRAF V600EMetastatic Melanoma
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Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients
vemurafenib FDA EUcobimetinib FDA EU
Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue BRAF V600 mutation test;
BRAF V600EMelanoma, Melanoma (Skin), Melanoma Stage
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Induction Therapy With Vemurafenib and Cobimetinib to Optimize Nivolumab and Ipilimumab Therapy
vemurafenib FDA EUcobimetinib FDA EU
Histologically or cytologically confirmed Stage IV, or unresectable stage III, BRAF V600E/K mutated melanoma
BRAF V600EMelanoma, Malignant, of Soft Parts
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LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma
LY3022855vemurafenib FDA EUcobimetinib FDA EU
…to the phase I portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or…
BRAF V600EMelanoma
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ML29255 Neoadjuvant Vemurafenib and Cobimetinib Melanoma
vemurafenib FDA EUcobimetinib FDA EU
Melanoma must be documented to contain a BRAFV600 mutation by a CLIA approved laboratory
BRAF V600EStage IIIB-C Melanoma
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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
vemurafenib FDA EUcobimetinib FDA EUatezolizumab FDA
…by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
BRAF V600EMalignant Melanoma
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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
cobimetinib FDA EUvemurafenib FDA EU
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 Adva…
BRAF V600EMetastatic Melanoma
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Vemurafenib and Cobimetinib Combination in BRAF Mutated Melanoma With Brain Metastasis
cobimetinib FDA EUvemurafenib FDA EU
Documented BRAFV600 mutation determined in a hospital center specializing in the molecular genetics of cancer…
BRAF V600EMalignant Melanoma
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Study of Neo-adjuvant Use of Vemurafenib Plus Cobimetinib for BRAF Mutant Melanoma With Palpable Lymph Node Metastases
vemurafenib FDA EUcobimetinib FDA EU
BRAF V600 mutation positive.
BRAF V600EMelanoma
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Clinical Trial to Evaluate the Efficacy of Vemurafenib in Combination With Cobimetinib (Continuous and Intermittent) in BRAFV600-mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
vemurafenib FDA EUcobimetinib FDA EU
… Efficacy of Vemurafenib in Combination With Cobimetinib (Continuous and Intermittent) in BRAFV600-mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
BRAF V600EMelanoma
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Phase II Study of Cobimetinib in Combination With Vemurafenib in Active Melanoma Brain Metastases
cobimetinib FDA EUvemurafenib FDA EU
Histologically confirmed metastatic melanoma (Stage IV), carrying BRAF V600-mutation
BRAF V600EActive Melanoma Brain Metastases
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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
trastuzumabpertuzumaberlotinibvemurafenib FDA EUcobimetinib FDA EUVismodegibalectinibatezolizumab FDA
…esting results from CLIA-certified laboratories (using tissue and/or blood) demonstrating BRAF V600 mutations a) For participants screened using a blood assay: obtain tissue-based testing r…
BRAF V600EALK fusionNeoplasms, Solid Tumors, Biliary Cancer, Salivary Cancer
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Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF Mutation
vemurafenib FDA EUPeg-interferoncobimetinib FDA EU
…ic melanoma at stage unreseactable IIIb-IV, histologically confirmed, that show V600 type BRAF mutations.
BRAF V600EMelanoma
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A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
ipilimumab FDA EUnivolumab FDA EUcobimetinibDaratumumabrelatlimab
Microsatellite instability expression detected by an accredited laboratory
MSI-H / dMMRMicrosatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer, Mismatch Repair Deficient Colorectal Cancer
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Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma
vemurafenib FDA EUbevacizumabcobimetinib FDA EU
Patients must have melanoma that is documented to contain a BRAFV600E or BRAFV600K mutation by a FDA-approved test.
BRAF V600EMelanoma, Metastatic Melanoma
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The Effects of Vemurafenib + Cobimetinib on Immunity in Patients With Melanoma
vemurafenib FDA EUcobimetinib FDA EU
Melanoma must be documented to contain a BRAFV600 mutation by a FDA approved assay
BRAF V600EMelanoma
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Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors
ABM-1310cobimetinib FDA EU
Part A: Patients with advanced or metastatic solid tumors with documentation of positive BRAF V600E mutation, or any other BRAF V600 mutation is required for enrollment
BRAF V600EAdvanced Solid Tumor, BRAF V600 Mutation
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HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors
belvarafenibcobimetinibcetuximab
KRAS-mutant NSCLC
KRAS G12CKRAS G12DBRAF V600ELocally Advanced Solid Tumor, Metastatic Solid Tumor
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Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma
pembrolizumabvemurafenib FDA EUcobimetinib FDA EU
Only patients with BRAF V600E or V600K mutated tumors will be enrolled.
BRAF V600EMelanoma
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Safety, Tolerability, and Pharmacokinetics of Onartuzumab Combined With Vemurafenib and/or Cobimetinib in Cancer Patients
cobimetinibOnartuzumabvemurafenib
Patients with a histologically confirmed, KRAS-mutant, Stage IV colorectal adenocarcinoma, or KRAS-mutant metastatic non-small-cell lung carcin…
KRAS G12CKRAS G12DBRAF V600ENeoplasms
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A Study of MEHD7945A and Cobimetinib in Patients With Locally Advanced or Metastatic Cancers With Mutant KRAS
cobimetinibMEHD7945A
Locally advanced or metastatic solid KRAS-mutant tumors, for which standard therapies do not exist, have proven ineffective or intolerable…
KRAS G12CKRAS G12DNeoplasms
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Treatment of a Resistant Disease Using Decitabine Combined With Vemurafenib Plus Cobimetinib
vemurafenib FDA EUcobimetinib FDA EUdecitabine
Phase 1/2 Study Epigenetic Modification of BRAF-mutated Metastatic Melanoma: Treatment of a Resistant Disease Using Decitabine Combined With Vemu…
BRAF V600EMetastatic Melanoma, Melanoma, BRAF-mutated Metastatic Melanoma, V600EBRAF-mutated Metastatic Melanoma
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A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma
atezolizumab FDAcobimetinib FDA EUvemurafenib FDA EU
…ologic or cytologic documentation of metastatic or Stage IIIc unresectable melanoma, with BRAFV600 mutation as assessed by BRAFV600 Mutation Test.
BRAF V600EMalignant Melanoma
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A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
cobimetinib FDA EUvemurafenib FDA EU
A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
BRAF V600EMalignant Melanoma
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SMMART Adaptive Clinical Treatment (ACT) Trial
alectinibalpelisibanastrozoleatezolizumabbevacizumab FDA EUcapecitabinecarboplatincobimetinibentrectiniberibulinfulvestrantpertuzumab
… least one prior line of therapy with a PARP inhibitor for triple negative disease with a BRCA1/2 mutation.
BRCA1/2 mutationAdvanced Breast Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Ovarian Carcinoma, Advanced Pancreatic Carcinoma
No trials match these filters.