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Brief Title: Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Official Title: A Phase II, Open-label, Randomized-controlled Trial Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody Atezolizumab for the Treatment in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Study ID: NCT02902029
Brief Summary: Most patients with locally advanced or metastatic tumors succumb to their disease. Thus, there is a substantial need for novel therapeutic strategies to improve the outcome for patients with advanced or metastatic melanoma. Targeting the the Ras/Raf signalling pathway by BRAF and MEK inhibition as well as targeting immunologic checkpoint control with an antiPD-L1 antibody have emerged as treatment option. In this study the best timing for sequential use of both treatment options (BRAF/MEK inhibition and antiPD-L1 antibody) in patients with unresectable or metastatic BRAFV600 mutant melanoma will be assessed.
Detailed Description: At this time there is no experience concerning the sequencing strategy when using the two effective therapeutical approaches as targeting the Ras/Raf signalling pathway by BRAF and MEK inhibition or targeting immunologic checkpoint control with an antiPD-L1 antibody. This is a prospective, open, multicenter, randomized phase II study in patients with unresectable or metastatic BRAFV600 mutant melanoma. In this study the scheduling of the treatment with a combined BRAF/MEK inhibition and the treatment with an anti-PD-L1 antibody will be assessed. After a 3 months run-in period with vemurafenib and cobimetinib, all patients who did not show disease progression or treatment interruption for more than 28 days during run-in phase will be randomized in a 1:1 ratio: * either to proceed vemurafenib and cobimetinib until disease progression and subsequently cross-over to atezolizumab treatment until disease progression (Arm A). * or to receive the anti-PD-L1 antibody atezolizumab until disease progression and subsequently cross-back to vemurafenib and cobimetinib until disease progression (Arm B). In a translational research program tumor tissue, blood plasma and peripheral blood mononuclear cell will be analyzed to evaluate the biologic effects of treatment sequence on the molecular profile and biomarker expression in tissue and plasma.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hôpital Ambroise-Paré, Boulogne-Billancourt, , France
Hospital Claude Huriez, Lille, , France
Hôpital de la Timone, Marseille, , France
CHU de Nantes, Nantes, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
SLK-Kliniken Heilbronn GmbH, Heilbronn, Baden-Wuerttemberg, Germany
University Hospital Mannheim, Clinic for Dermatology, Mannheim, Baden-Wuerttemberg, Germany
National Centre for Tumour Diseases (NCT), Heidelberg, BW, Germany
University Hospital Essen, Department of Dermatology, Skin Cancer Center, Essen, North Rhine-Westphalia, Germany
HELIOS Klinikum Erfurt, Erfurt, Thuringia, Germany
Charité-Universitätsmedizin Berlin, Berlin, , Germany
Elbe Kliniken Stade - Buxtehude, Buxtehude, , Germany
Universitätsklinik Dresden, Dresden, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum des Saarlandes, Homburg/Saar, , Germany
Universitäts-Hautklinik Kiel, Kiel, , Germany
Universitätsklinikum Köln, Köln, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
Gesellschaft für Klinische Forschung Ludwigshafen mbH, Ludwigshafen, , Germany
Universitätsklinikum Schleswig-Holstein, Lübeck, , Germany
Universitätsklinikum Mainz, Mainz, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Klinikum der Universität München, München, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Uniklinikum Würzburg, Würzburg, , Germany
"LAIKO" General Hospital of Athens, Athens, , Greece
Military Medical Academy, Belgrad, , Serbia
Name: Dirk Schadendorf, Prof. Dr.
Affiliation: University Hospital, Essen
Role: PRINCIPAL_INVESTIGATOR