Spots Global Cancer Trial Database for To Evaluate the Efficacy Beyond Progression of Vemurafenib+Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600+ Metastatic Melanoma in Focal Progression With First-line+Vemurafenib+Cobimetinib.
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Trial Identification
Brief Title: To Evaluate the Efficacy Beyond Progression of Vemurafenib+Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600+ Metastatic Melanoma in Focal Progression With First-line+Vemurafenib+Cobimetinib.
Official Title: An Evaluation of the Efficacy Beyond Progression of Vemurafenib Combined With Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600 Mutation-positive Metastatic Melanoma in Focal Progression With First-line Combined Vemurafenib and Cobimetinib.
Study ID: NCT03514901
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
Detailed Description: Melanoma is a heterogeneous skin tumor, characterized by mutations of different oncogenes. Almost half of patients with advanced melanoma have a gene mutation of BRAF serine-threonine kinase. Over the past 5 years, two BRAF inhibitors targeting these mutations, vemurafenib and dabrafenib, have shown high rates of rapid response in phase II and III studies. However, the duration of responses is limited in most patients due to the development of acquired resistance. Mechanisms of resistance to BRAF inhibitor therapy are diverse and include the reactivation of the mitogen-activated protein kinase (MAPK) pathway in over two-thirds of tumors, along with promotion of parallel signaling networks. Recently, the combination of drugs was superior in terms of responses, Progression Free Survival (PFS) and Overall Survival (OS) compared to monotherapy. The data from recent studies confirm the clinical benefit of the combination of Vemurafenib with cobimetinib and support the use of the combination as a standard first-line approach to improve survival in patients. The aim of this randomized, open-label, phase II study is to evaluate the efficacy, in terms of overall survival, of vemurafenib combined with cobimetinib associated with local treatment compared with second-line therapy, in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Istituto dei Tumori "Giovanni Paolo II", Bari, BA, Italy
ASST Papa Giovanni XXIII, Bergamo, BG, Italy
Policlinico Sant'Orsola Malpighi, Bologna, BO, Italy
IRCCS IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, FC, Italy
Ospedale Policlinico San Martino, Genova, GE, Italy
P.O. di Taormina - Azienda Sanitaria Provinciale di Messina, Taormina, ME, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, MI, Italy
Istituto Oncologico Veneto - IRCCS, Padova, PD, Italy
Ospedale S. Chiara - A.O.U. Pisana, Pisa, PI, Italy
A.O.U.S. Policlinico "Le Scotte", Siena, SI, Italy
P.O. San Lazzaro - A.O.U. Città della Salute e della Scienza di Torino - Molinette, Torino, TO, Italy
Istituto Europeo di Oncologia - Divisione Melanoma, Sarcoma e Tumori Rari, Milano, , Italy
Istituti Fisioterapici Ospitalieri - IFO - Istituto "Regina Elena", Roma, , Italy
IDI Istituto Dermopatico Immacolata, Roma, , Italy
Contact Details
Name: Paola Queirolo, Dr.
Affiliation: Ospedale Policlinico San Martino di Genova
Role: PRINCIPAL_INVESTIGATOR
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