Cobimetinib

Generic Name: Cobimetinib

Brand Names: Cotellic

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₁F_₃IN_₃O_₂

CAS Number: 934660-93-2

Unique Ingredient Identifier: ER29L26N1X

Background: Cobimetinib is an orally active, potent and highly selective small molecule inhibiting mitogen-activated protein kinase kinase 1 (MAP2K1 or MEK1), and central components of the RAS/RAF/MEK/ERK signal transduction pathway. It has been approved in Switzerland and the US, in combination with vemurafenib for the treatment of patients with unresectable or metasta...

Indication: Cobimetinib is indicated in combination with vemurafenib for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. As a single agent, cobimetinib is also indicated for the treatment of adult patients with histiocytic neoplasms.

Associated Conditions: Histiocytic Neoplasm, Metastatic Melanoma, Unresectable Melanoma

Associated Therapies: -

Clinical Trials

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.

Phase 1

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Belvarafenib
Drug: Cobimetinib
Drug: Nivolumab

First Posted Date: 2021-04-08

Last Posted Date: 2024-08-14

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 65

Registration Number: NCT04835805

Locations: 🇩🇪
Universitätsklinikum Würzburg, Würzburg, Germany
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
Memorial Sloan Kettering, New York, New York, United States

and more 20 locations

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Not Applicable

Terminated

Conditions: Cancer

Interventions: Drug: Trametinib
Drug: Cobimetinib
Drug: Binimetinib
Drug: Alpelisib
Drug: Vemurafenib
Drug: Dabrafenib
Drug: Encorafenib
Drug: Palbociclib
Drug: Olaparib
Drug: Ribociclib
Drug: Abemaciclib
Drug: Talazoparib
Drug: Nivolumab
Drug: Atezolizumab
Drug: Pembrolizumab

First Posted Date: 2021-03-17

Last Posted Date: 2023-05-10

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 3

Registration Number: NCT04801966

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

First Posted Date: 2020-10-19

Last Posted Date: 2023-10-03

Lead Sponsor: Fondazione per la Medicina Personalizzata

Target Recruit Count: 400

Registration Number: NCT04591431

Locations: 🇮🇹
I.R.S.T. Srl Irccs, Meldola, Italy
🇮🇹
Ospedale Classificato Sacro Cuore - Don Calabria, Negrar, Italy
🇮🇹
I.R.C.C.S. Istituto Oncologico Veneto, Padova, Italy

and more 34 locations

CRAFT: the NCT-PMO-1602 Phase II Trial

Phase 2

Active, not recruiting

Conditions: Metastatic or Locally Advanced Malignancies

Interventions: Drug: Vemurafenib
Drug: Trastuzumab
Drug: Alectinib
Drug: Ipatasertib
Drug: Inavolisib
Drug: Cobimetinib
Drug: Pertuzumab
Drug: Atezolizumab

First Posted Date: 2020-09-16

Last Posted Date: 2024-12-11

Lead Sponsor: German Cancer Research Center

Target Recruit Count: 175

Registration Number: NCT04551521

Locations: 🇩🇪
Charité - Universitätsmedizin Berlin, Berlin, Germany
🇩🇪
Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg, Germany
🇩🇪
Universitätsklinikum Freiburg, Freiburg, Germany

and more 5 locations

Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations

Phase 2

Recruiting

Conditions: Chronic Myelomonocytic Leukemia (CMML)

Interventions: Drug: Cobimetinib

First Posted Date: 2020-06-01

Last Posted Date: 2024-02-28

Lead Sponsor: University of Utah

Target Recruit Count: 29

Registration Number: NCT04409639

Locations: 🇺🇸
Oregon Health and Science University, Portland, Oregon, United States
🇺🇸
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma

Phase 1

Active, not recruiting

Conditions: Sarcoma,Soft Tissue

Interventions: Drug: Cobimetinib
Drug: Atezolizumab

First Posted Date: 2020-01-03

Last Posted Date: 2024-07-08

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 320

Registration Number: NCT04216953

Locations: 🇫🇷
Hôpital de la Timone, Marseille, France
🇫🇷
Institut Gustave Roussy, Villejuif, France
🇫🇷
Institut Curie, Paris, France

and more 3 locations

Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies

Phase 1

Terminated

Conditions: Gastrointestinal Cancer

Interventions: Drug: Cobimetinib
Drug: Hydroxychloroquine
Drug: Atezolizumab

First Posted Date: 2020-01-02

Last Posted Date: 2024-12-18

Lead Sponsor: Columbia University

Target Recruit Count: 27

Registration Number: NCT04214418

Locations: 🇺🇸
Columbia University Irving Medical Center, New York, New York, United States
🇺🇸
Brown University, Providence, Rhode Island, United States

Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors

Phase 1

Terminated

Conditions: Advanced Solid Tumor
BRAF V600 Mutation

Interventions: Drug: ABM-1310
Drug: Cobimetinib

First Posted Date: 2019-12-09

Last Posted Date: 2024-05-21

Lead Sponsor: ABM Therapeutics Corporation

Target Recruit Count: 53

Registration Number: NCT04190628

Locations: 🇺🇸
Robert H. Lurie Comprehensive Cancer Center (Northwestern University), Chicago, Illinois, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Stanford University School of Medicine, Stanford, California, United States

and more 5 locations

A MolEcularly Guided Anti-Cancer Drug Off-Label Trial

Phase 2

Active, not recruiting

Conditions: Solid Tumor

Interventions: Drug: Everolimus
Drug: Atezolizumab
Drug: Niraparib
Drug: Cobimetinib

First Posted Date: 2019-12-04

Last Posted Date: 2024-08-22

Lead Sponsor: Uppsala University Hospital

Target Recruit Count: 167

Registration Number: NCT04185831

Locations: 🇸🇪
Skane University Hospital, Lund, Sweden
🇸🇪
Uppsala University Hospital, Uppsala, Sweden
🇸🇪
Sahlgrenska University Hospital, Gothenburg, Sweden

IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma

Phase 1

Active, not recruiting

Conditions: Metastatic Melanoma

Interventions: Drug: IN10018
Drug: Cobimetinib
Biological: Atezolizumab

First Posted Date: 2019-09-30

Last Posted Date: 2024-11-28

Lead Sponsor: InxMed (Shanghai) Co., Ltd.

Target Recruit Count: 120

Registration Number: NCT04109456

Locations: 🇺🇸
Sylvester Comprehensive Cancer Center., Miami, Florida, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 5 locations

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