Sequential Combo Immuno and Target Therapy (SECOMBIT) Study

PHASE2CompletedINTERVENTIONAL
Enrollment

251

Participants

Timeline

Start Date

November 14, 2016

Primary Completion Date

May 31, 2024

Study Completion Date

May 31, 2024

Conditions
Metastatic Melanoma
Interventions
DRUG

LGX818

LGX818 450 mg p.o. od

DRUG

MEK162

MEK162 45 mg p.o. bid

DRUG

Nivolumab

Nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks

DRUG

Ipilimumab

Nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks

Trial Locations (30)

1090

Medical University of Vienna, Vienna

3100

Karl Landsteiner University of Health Sciencies - University Clinic, Sankt Pölten

5020

Paracelsus Medical University, Salzburg

10126

Azienda Ospedaliera Universitaria - Città della Salute e della Scienza di Torino, Torino

11527

University of Athens, Athens

16132

IRCCS San Martino - IST, Genova

20133

Fondazione I.R.C.C.S. Istituto Nazionale dei Tumori, Milan

24127

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

28027

Clinica Universidad de Navarra, Pamplona

35128

Istituto Oncologico Veneto, Padua

47014

IRCCS - Istituto Scientifico Romagnolo per la Cura e lo Studio dei Tumori (I.R.S.T) S.r.l., Meldola

70124

National Institute of Cancer, Bari

Università degli Studi di Bari Aldo Moro, Bari

72074

University of Tuebingen, Tübingen

75010

Hôpitaux Universitaires Saint-Louis, Paris

80131

"Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Giovanni Pascale", Naples

A-803

Medical University of Graz, Graz

Unknown

IEO - Istituto Europeo di Oncologia - IRCCS, Milan

Azienda Ospedaliero Universitaria Federico II, Naples

IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo

Azienda Ospedaliera Universitaria Integrata di Udine, Udine

00144

Istituto Nazionale Tumori Regina Elena, Roma

00167

Istituto Dermopatico dell'Immacolata - IDI - IRCCS, Roma

02781

Maria Sklodowska-Curie Institute - Oncology Center, Warsaw

08028

Hospital Universitario Quiròn Dexeus, Barcelona

08036

Hospital Clínic Barcelona, Barcelona

S-171

Karolinska University Hospital, Stockholm

CH809

University Hospital Zurich, Zurich

SW36J

The Royal Marsden NHS Foundation Trust, London

M204B

The Christie NHS Foundation Trust, Manchester

Sponsors
All Listed Sponsors
collaborator

Clinical Research Technology S.r.l.

INDUSTRY

lead

Fondazione Melanoma Onlus

OTHER

NCT02631447 - Sequential Combo Immuno and Target Therapy (SECOMBIT) Study | Biotech Hunter | Biotech Hunter