Spots Global Cancer Trial Database for Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib
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Trial Identification
Brief Title: Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib
Official Title: Combination of Targeted Therapy (Encorafenib and Binimetinib) Followed by Combination of Immunotherapy (Ipilimumab and Nivolumab) vs Immediate Combination of Immunotherapy in Patients With Unresectable or Metastatic Melanoma With BRAF V600 Mutation : an EORTC Randomized Phase II Study (EBIN)
Study ID: NCT03235245
Study Description
Brief Summary: This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospitals Copenhagen - Herlev Hospital - University Copenhagen, Herlev, , Denmark
Odense University Hospital, Odense, , Denmark
Helsinki University Central Hospital - Dept of Oncology, Helsinki, , Finland
Tampere University Hospital, Tampere, , Finland
CHU Amiens - Hopital Sud, Amiens, , France
CHRU de Besançon - Hopital Jean Minjoz, Besançon, , France
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre, Bordeaux, , France
Centre Jean Perrin, Clermont-Ferrand, , France
CHU de Dijon - Centre Georges-François-Leclerc, Dijon, , France
CHU de Grenoble - La Tronche - Hôpital A. Michallon, Grenoble, , France
CHRU de Lille, Lille, , France
Centre Hospitalier Lyon Sud, Lyon, , France
Centre Leon Berard, Lyon, , France
Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (APHM), Marseille, , France
CHU de Nice - Hopital De L'Archet, Nice, , France
Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis, Paris, , France
CHU Ambroise Pare, Paris, , France
Centre Hospitalier De Pau, Pau, , France
CHU de Saint-Etienne - Hopital Nord, Saint Priest en Jarez, , France
CHU de Tours - Hopital Trousseau, Tours, , France
Gustave Roussy, Villejuif, , France
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Univ. Mainz - Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center, Mainz, , Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, , Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Napoli, , Italy
IRCCS - Istituto Oncologico Veneto, Padova, , Italy
IRCCS-Regina Elena National Cancer Center, Roma, , Italy
Universita Degli Studi Di Siena -Policlinico "le Scotte", Siena, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Turin, , Italy
Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine, Udine, , Italy
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw, , Poland
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia), Badalona, , Spain
Hospital Clinic Universitari de Barcelona, Barcelona, , Spain
Vall d'Hebron Institut d'Oncologia, Barcelona, , Spain
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital, Glasgow, , United Kingdom
East & North Hertfordshire NHS Trust - East and North Hertfordshire NHS Trust - Mount Vernon Hospital, Middlesex, , United Kingdom
Contact Details
Name: Caroline Robert
Affiliation: Cancer Institute Gustave Roussy
Role: PRINCIPAL_INVESTIGATOR
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