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Brief Title: Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC
Official Title: Neoadjuvant Treatment With the Combination of Vemurafenib, Cobimetinib and Atezolizumab in Limited Metastasis of Malignant Melanoma (AJCC Stage IIIC/IV) and Integrated Biomarker Study: a Single Armed, Two Cohort, Phase II EADO Trial NEO-VC
Study ID: NCT02303951
Brief Summary: Evaluation of the efficacy, safety and biologic effects of neo-adjuvant treatment with vemurafenib + cobimetinib + atezolizumab in patients with limited metastasis of melanoma in stage IIIC/IV melanoma.
Detailed Description: Patients with hardly resectable/unresectable limited metastasis in malignant melanoma stages IIIC/IV (AJCC 2010) carrying the BRAF V600 mutation, in order to achieve operability are enrolled in the NEO-VC-study. The main aim of this study is to achieve operability in a higher percentage of patients by neoadjuvant treatment through shrinkage of the tumors. Patients with operable stage IV disease show an impressive survival benefit with long term (5 y.) survival rates around 30 %. Only a percentage of up to 20 % can presently be treated by complete metastasectomy. This percentage may be enlarged by pre-treatment with an efficacious antitumor drug.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Dermatology & Skin Cancer University Hospital La Timone, Aix-Marseille University, Marseille, , France
Department of Dermatology, University Hospital of Nantes, Nantes, , France
Hopital Saint-Louis Hopitaux Universitaires Saint-Louis Laboisiere Fernand-Widal, Paris, , France
Department of Dermatology, Elbe Hospital, Buxtehude, , Germany
Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
Department of Dermatology, University Hospital, Kiel, , Germany
University hospital Tübingen, Tübingen, , Germany
Name: Claus Garbe, Prof.
Affiliation: University Hospital Tübingen
Role: PRINCIPAL_INVESTIGATOR