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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Dirk Schadendorf, Prof. Dr.

Affiliation: University Hospital, Essen

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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