Biomarker-based Study in R/M SCCHN

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

November 16, 2017

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Carcinoma, Squamous Cell of Head and Neck
Interventions
DRUG

Afatinib

Afatinib 40 mg given orally, once daily, 1 cycle is 28 days

DRUG

Palbociclib

Palbociclib 125 mg given orally, once daily, 1 cycle is 28 days (21 days on treatment, then 7 days off)

DRUG

standard of care

Methotrexate, Paclitaxel, Docetaxel, Carboplatin, 5-Fluorouracil, Bleomycine, Gemcitabine, Mitomycine or Best supportive care

DRUG

IPH2201

protocol v2.0 and 2.1 : Monalizumab 10mg/kg given intravenously over 60 minutes, once every 14 days, 1 cycle is 14 days protocol v4.0 : Monalizumab 750mg given intravenously over 60 minutes, once every 28 days, 1 cycle is 28 days

DRUG

Durvalumab

Durvalumab 1500mg given intravenously over 60 minutes, once every 28 days, 1 cycle is 28 days

DRUG

Niraparib

Niraparib 300 mg given orally, once daily, 1 cycle is 28 days

DRUG

INCAGN01876

INCAGN01876 300 mg given intravenously over 30 minutes, once every 14 days, 1 cycle is 28 days

Trial Locations (36)

1000

CHU Saint-Pierre-Site Porte de Hal, Brussels

3000

U.Z. Leuven - Campus Gasthuisberg, Leuven

28041

Hospital Universitario 12 De Octubre, Madrid

46010

Hospital Clinico Universitario De Valencia, Valencia

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

59020

Centre Oscar Lambret, Lille

67200

Institut de Cancerologie Strasbourg Europe, Strasbourg

80131

IRCCS - Fondazione G. Pascale, Napoli

Unknown

Cliniques Universitaires Saint-Luc, Brussels

Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet, Brussels

Grand Hopital de Charleroi - Grand Hôpital de Charleroi - Site Notre Dame, Charleroi

Universitair Ziekenhuis Antwerpen, Edegem

Universitair Ziekenhuis Gent, Ghent

Hopital De Jolimont, Haine-Saint-Paul

AZ Groeninge Kortrijk - Campus Kennedylaan, Kortrijk

U.Z. Leuven - Campus Gasthuisberg, Leuven

GasthuisZusters Antwerpen - Sint-Augustinus, Wilrijk

CHU Dinant Godinne - UCL Namur, Yvoir

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

Centre Georges-Francois-Leclerc, Dijon

Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau, Nantes

Centre Antoine Lacassagne, Nice

Institut Curie, Paris

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

Gustave Roussy, Villejuif

Azienda Ospedaliero-Universitaria Careggi, Florence

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

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

University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre, Birmingham

NHS Lothian - Western General Hospital, Edinburgh

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

Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital, London

Oxford University Hospitals NHS Trust - Churchill Hospital, Oxford

Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital, Sheffield

08908

ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia), Barcelona

EH4 2XU

NHS Lothian - Western General Hospital, Edinburgh

All Listed Sponsors
lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

NCT03088059 - Biomarker-based Study in R/M SCCHN | Biotech Hunter | Biotech Hunter