Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

271

Participants

Timeline

Start Date

October 30, 2018

Primary Completion Date

October 24, 2023

Study Completion Date

January 31, 2027

Conditions
Unresectable Stage III MelanomaStage IV Melanoma
Interventions
DRUG

Nivolumab + Ipilimumab

nivolumab 3 mg/kg q3w + ipilimumab 1 mg/kg q3w for 4 injections followed by nivolumab 480 mg IV q4w until completion of 2 years total treatment or progression.

DRUG

Encorafenib + Binimetinib

encorafenib 450 mg QD + binimetinib 45 mg BID orally for 12 weeks

Trial Locations (38)

Unknown

University Hospitals Copenhagen - Herlev Hospital - University Copenhagen, Herlev

Odense University Hospital, Odense

Helsinki University Central Hospital - Dept of Oncology, Helsinki

Tampere University Hospital, Tampere

CHU Amiens - Hopital Sud, Amiens

CHRU de Besançon - Hopital Jean Minjoz, Besançon

CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre, Bordeaux

Centre Jean Perrin, Clermont-Ferrand

CHU de Dijon - Centre Georges-François-Leclerc, Dijon

CHU de Grenoble - La Tronche - Hôpital A. Michallon, Grenoble

CHRU de Lille, Lille

Centre Hospitalier Lyon Sud, Lyon

Centre Leon Berard, Lyon

Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (APHM), Marseille

CHU de Nice - Hopital De L'Archet, Nice

Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis, Paris

CHU Ambroise Pare, Paris

Centre Hospitalier De Pau, Pau

CHU de Saint-Etienne - Hopital Nord, Saint-Priest-en-Jarez

CHU de Tours - Hopital Trousseau, Tours

Gustave Roussy, Villejuif

Universitaetsklinikum Heidelberg, Heidelberg

Univ. Mainz - Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center, Mainz

Universitaetsklinikum Wuerzburg, Würzburg

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

"Istituto Nazionale Tumori IRCCS Fondazione G. Pascale", Napoli

IRCCS - Istituto Oncologico Veneto, Padua

IRCCS-Regina Elena National Cancer Center, Roma

"Universita Degli Studi Di Siena -Policlinico le Scotte", Siena

Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Turin

"Azienda Ospedaliero-Universitaria Santa Maria della Misericordia di Udine", Udine

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam

Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw

Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia), Badalona

Hospital Clinic Universitari de Barcelona, Barcelona

Vall d'Hebron Institut d'Oncologia, Barcelona

NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital, Glasgow

East & North Hertfordshire NHS Trust - East and North Hertfordshire NHS Trust - Mount Vernon Hospital, Middlesex

All Listed Sponsors
lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

NCT03235245 - Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib | Biotech Hunter | Biotech Hunter