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DRUG CLASS:

MEK1 inhibitor

3d
Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer (clinicaltrials.gov)
P2, N=37, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive
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Tecentriq (atezolizumab) • Cotellic (cobimetinib) • Halaven (eribulin mesylate)
4d
Trial completion • Enrollment change
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
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HER-2 negative • HER-2 expression
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cisplatin • Tecentriq (atezolizumab) • paclitaxel • 5-fluorouracil • Cotellic (cobimetinib) • Cyramza (ramucirumab) • oxaliplatin • leucovorin calcium • tiragolumab (RG6058) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide)
11d
XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma (clinicaltrials.gov)
P1, N=26, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2025 --> Nov 2026
Trial completion date
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BRAF (B-raf proto-oncogene)
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BRAF mutation • BRAF V600
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Zelboraf (vemurafenib) • Cotellic (cobimetinib) • XL888
25d
Tumor-intrinsic MHC-II activation in pancreatic ductal adenocarcinoma enhances immune response and treatment efficacy. (PubMed, bioRxiv)
In the KPC mouse model of PDAC, pharmacologic induction of MHC-II expression by cobimetinib treatment in malignant epithelial cells significantly enhanced the therapeutic response to immune checkpoint blockade (ICB)...Our results position MHC-II as a promising prognostic biomarker and therapeutic target in PDAC, paving the way for novel immunomodulatory strategies. Single-cell and spatial transcriptomic analyses reveal that elevated MHC-II expression in malignant PDAC cells correlates with increased infiltration of CD4⁺ and CD8⁺ T cells.Stimulating MHC-II expression in tumors effectively enhances immunotherapeutic responses to ICB in the PDAC KPC mouse model, including PDAC tumors previously resistant to therapeutic interventions.MHC-II serves as a prognostic biomarker and a promising target for immunotherapy in PDAC.
Journal • IO biomarker
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CD8 (cluster of differentiation 8) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • CD4 (CD4 Molecule)
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Cotellic (cobimetinib)
28d
CONCERTO: Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations (clinicaltrials.gov)
P2, N=29, Recruiting, University of Utah | Trial primary completion date: Aug 2025 --> Jan 2026
Trial primary completion date
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • FLT3 (Fms-related tyrosine kinase 3) • NRAS (Neuroblastoma RAS viral oncogene homolog) • NF1 (Neurofibromin 1) • JAK2 (Janus kinase 2) • PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11)
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BRAF mutation
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Cotellic (cobimetinib)
2ms
A single center, single arm, prospective clinical study initiated by a researcher on the efficacy and safety of FCN-159 table (ChiCTR2500109679)
P=N/A, N=20, Completed, Beijing Childrens Hospital,Capital Medical University; Beijing Childrens Hospital,Capital Medical University
New trial
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luvometinib (FCN-159)
2ms
CASPER: Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov)
P1, N=15, Active, not recruiting, OHSU Knight Cancer Institute | Recruiting --> Active, not recruiting
Enrollment closed
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Cotellic (cobimetinib) • Asparlas (calaspargase pegol-mknl)
2ms
Phase 1 Study of Luvometinib Use in Pediatric Patients with Neurofibromatosis Type 1-Related Unresectable Plexiform Neurofibromas. (PubMed, Target Oncol)
Luvometinib had a manageable safety profile in pediatric patients with unresectable NF1-related PN. Encouraging preliminary efficacy was observed, particularly among patients receiving the RP2D of 5 mg/m2, supporting further investigation of luvometinib in this setting.
P1 data • Journal
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NF1 (Neurofibromin 1)
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luvometinib (FCN-159)
2ms
Phenotype switching in highly invasive resistant to vemurafenib and cobimetinib melanoma cells. (PubMed, Cell Commun Signal)
In summary, our study characterized a significantly more invasive phenotype of double-resistant cell lines compared to melanoma cells sensitive to BRAF and MEK inhibitors. Successful inhibition of this phenotype could result in more effective therapy and thus a better prognosis for patients.
Journal
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VCL (Vinculin) • MMP14 (Matrix Metallopeptidase 14) • RUNX2 (RUNX Family Transcription Factor 2)
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BRAF mutation
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Zelboraf (vemurafenib) • Cotellic (cobimetinib)
2ms
Erdheim-Chester Disease Masquerading as Leukemia: Outwitting the Need for Transplant. (PubMed, Cureus)
While BRAF mutations are common in ECD, RAS isoforms occur in a smaller subset. This case highlights RAS-positive ECD, managed with KRAS pathway-targeted MEK inhibition, in line with the 2019 ECD Medical Symposium recommendations.
Journal
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
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KRAS mutation • BRAF mutation
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Cotellic (cobimetinib)
2ms
ETCTN Study 10166: Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=51, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Jul 2026 --> Jul 2025
Trial primary completion date • Tumor mutational burden • IO biomarker
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)
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KRAS wild-type • RAS wild-type
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Tecentriq (atezolizumab) • Cotellic (cobimetinib)
3ms
A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC (clinicaltrials.gov)
P1/2, N=16, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Jan 2027 --> Jan 2031 | Trial primary completion date: Jan 2025 --> Jan 2029
Trial completion date • Trial primary completion date
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ALK rearrangement
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Alecensa (alectinib) • Cotellic (cobimetinib)