- |||||||||| Mekinist (trametinib) / Novartis, BeiGene, Tafinlar (dabrafenib) / Novartis
Enrollment closed: BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC) (clinicaltrials.gov) - Jan 3, 2019 P2, N=170, Active, not recruiting, Active, not recruiting --> Completed | Trial primary completion date: Nov 2017 --> Sep 2018 Recruiting --> Active, not recruiting
- |||||||||| Biomarker, Enrollment change, Trial termination, Metastases: Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites (clinicaltrials.gov) - Jan 3, 2019
P2b, N=6, Terminated, Active, not recruiting --> Completed | N=45 --> 28 | Trial primary completion date: Sep 2016 --> Aug 2015 N=30 --> 6 | Completed --> Terminated; This study was terminated due to the limited enrollment.
- |||||||||| Biomarker, New P1 trial, PD(L)-1 Biomarker, IO biomarker, Surgery, Metastases: Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov) - Jan 3, 2019
P1, N=40, Recruiting,
- |||||||||| navtemadlin (KRT-232) / Kartos Therap
Trial completion, Trial completion date, Trial primary completion date, Metastases: A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma (clinicaltrials.gov) - Dec 17, 2018 P1b/2a, N=31, Completed, Trial primary completion date: Dec 2018 --> Dec 2019 Active, not recruiting --> Completed | Trial completion date: Oct 2019 --> Dec 2018 | Trial primary completion date: Oct 2019 --> Dec 2018
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene
Enrollment open, Surgery, Metastases: SARC033: Trametinib in Treating Patients With Epithelioid Hemangioendothelioma That is Metastatic, Locally Advanced, or Cannot Be Removed by Surgery (clinicaltrials.gov) - Dec 17, 2018 P2, N=27, Recruiting, Active, not recruiting --> Completed | Trial completion date: Oct 2019 --> Dec 2018 | Trial primary completion date: Oct 2019 --> Dec 2018 Suspended --> Recruiting
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene, spartalizumab (PDR001) / Novartis, Tafinlar (dabrafenib) / Novartis
New P3 trial, Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: COMBI-i: A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma (clinicaltrials.gov) - Dec 14, 2018 P3, N=538, Not yet recruiting,
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene, Tafinlar (dabrafenib) / Novartis
Trial completion date, Surgery: Combi-Neo: Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation (clinicaltrials.gov) - Dec 13, 2018 P2, N=78, Recruiting, Targeted therapies, lenvatinib and dabrafenib plus trametinib (for BRAF V600E mutants), may provide clinical benefit in ATC patients who are unable to participate in clinical trials, with manageable toxicities. Trial completion date: Oct 2020 --> Oct 2019
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene, uprosertib (LAE003) / Laekna Therap
Biomarker, Enrollment change, Combination therapy: Biospecimen Collection in Assessing the Effect of Trametinib With or Without Uprosertib on Biomarkers in Patients With Persistent or Recurrent Endometrial Cancer Enrolled on Trial GOG02290 (clinicaltrials.gov) - Nov 23, 2018 P2, N=40, Active, not recruiting, Recruiting --> Active, not recruiting N=25 --> 40
- |||||||||| Trial initiation date, PARP Biomarker, Metastases: MatchMel: Molecular Profiling and Matched Targeted Therapy for Patients With Metastatic Melanoma (clinicaltrials.gov) - Nov 2, 2018
P4, N=1000, Not yet recruiting, This article provides a comprehensive review of mechanisms of resistance to BRAF and MEK inhibitors in melanoma and summarizes landmark trials that led to the FDA approval of BRAF and MEK inhibitors in metastatic melanoma. Initiation date: Aug 2018 --> Feb 2019
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene, Keytruda (pembrolizumab) / Merck (MSD), Tafinlar (dabrafenib) / Novartis
Trial completion date, Trial primary completion date, PD(L)-1 Biomarker: NeoTrio: Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma (clinicaltrials.gov) - Nov 2, 2018 P2, N=60, Recruiting, Initiation date: Aug 2018 --> Feb 2019 Trial completion date: Nov 2019 --> Nov 2020 | Trial primary completion date: Nov 2018 --> Nov 2019
- |||||||||| naporafenib (ERAS-254) / Erasca
Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma (clinicaltrials.gov) - Oct 26, 2018 P1, N=127, Recruiting, Trial completion date: Dec 2022 --> Dec 2021 Trial completion date: Nov 2019 --> Jun 2020 | Trial primary completion date: Oct 2018 --> Jun 2019
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene, Tafinlar (dabrafenib) / Novartis, BeiGene
Enrollment open, Trial initiation date, Metastases: MERAIODE: Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer (clinicaltrials.gov) - Oct 24, 2018 P2, N=87, Recruiting, Trial completion date: Nov 2019 --> Jun 2020 | Trial primary completion date: Oct 2018 --> Jun 2019 Active, not recruiting --> Recruiting | Initiation date: Jul 2017 --> Dec 2017
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene, spartalizumab (PDR001) / Novartis, Tafinlar (dabrafenib) / Novartis
Enrollment open, Combination therapy, PD(L)-1 Biomarker, Metastases: Dabrafenib + Trametinib + PDR001 In Colorectal Cancer (clinicaltrials.gov) - Oct 19, 2018 P2, N=25, Recruiting, Active, not recruiting --> Recruiting | Initiation date: Jul 2017 --> Dec 2017 Not yet recruiting --> Recruiting
- |||||||||| navtemadlin (KRT-232) / Kartos Therap
Trial completion date, Metastases: A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma (clinicaltrials.gov) - Oct 12, 2018 P1b/2a, N=31, Active, not recruiting, Trial completion date: Dec 2022 --> Sep 2024 Trial completion date: Aug 2021 --> Oct 2019
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene, Tafinlar (dabrafenib) / Novartis
Trial completion date, Trial primary completion date: BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC) (clinicaltrials.gov) - Oct 11, 2018 P2, N=170, Active, not recruiting, Trial completion date: Aug 2021 --> Oct 2019 Trial completion date: Oct 2018 --> Apr 2019 | Trial primary completion date: Oct 2018 --> Apr 2019
- |||||||||| Mekinist (trametinib) / Novartis, Talzenna (talazoparib) / Pfizer
Biomarker, Preclinical, Journal, PARP Biomarker: A murine preclinical syngeneic transplantation model for breast cancer precision medicine. (Pubmed Central) - Oct 11, 2018 PSP score-based classification of The Cancer Genome Atlas breast cancer suggested that a subset of patients with limited therapeutic options would be expected to benefit from PARP-targeted drugs. These results indicate that MDSTs are useful models for studies of targeted therapies, and propose novel potential biomarkers for identification of breast cancer patients likely to benefit from personalized pharmacological treatments.
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene
Trial suspension, Surgery, Metastases: SARC033: Trametinib in Treating Patients With Epithelioid Hemangioendothelioma That is Metastatic, Locally Advanced, or Cannot Be Removed by Surgery (clinicaltrials.gov) - Oct 9, 2018 P2, N=27, Suspended, These results indicate that MDSTs are useful models for studies of targeted therapies, and propose novel potential biomarkers for identification of breast cancer patients likely to benefit from personalized pharmacological treatments. Recruiting --> Suspended
- |||||||||| Journal: Update on hairy cell leukemia. (Pubmed Central) - Sep 28, 2018
Rituximab has limited activity as a single agent but achieves high complete remission rates without minimal residual disease when combined with purine analogues, albeit with chemotherapy-associated toxicity. Investigational nonchemotherapy options include moxetumomab pasudotox, which targets CD22; vemurafenib or dabrafenib, each of which targets the BRAF V600E protein; trametinib, which targets mitogen-activated protein kinase enzyme (MEK); and ibrutinib, which targets Bruton tyrosine kinase (BTK).
- |||||||||| Mekinist (trametinib) / Novartis
Biomarker, Journal: MEK inhibitors block growth of lung tumours with mutations in ataxia-telangiectasia mutated. (Pubmed Central) - Sep 26, 2018 Here we report that ATM loss-of-function is synthetic lethal with drugs inhibiting the central growth factor kinases MEK1/2, including the FDA-approved drug trametinib...ATM loss also enhances the sensitivity of KRAS- or BRAF-mutant lung cancer cells to MEK inhibition. Thus, ATM mutational status in lung cancer is a mechanistic biomarker for MEK inhibitor response, which may improve patient stratification and extend the applicability of these drugs beyond RAS and BRAF mutant tumours.
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene, Tafinlar (dabrafenib) / Novartis
Trial completion date, Combination therapy: Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). (clinicaltrials.gov) - Sep 26, 2018 P3, N=870, Active, not recruiting, Thus, ATM mutational status in lung cancer is a mechanistic biomarker for MEK inhibitor response, which may improve patient stratification and extend the applicability of these drugs beyond RAS and BRAF mutant tumours. Trial completion date: Mar 2023 --> Nov 2030
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