Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

October 31, 2021

Study Completion Date

October 31, 2022

Conditions
Carcinoma, Renal CellClear-cell Metastatic Renal Cell Carcinoma
Interventions
BIOLOGICAL

Nivolumab/Ipilimumab

"* Induction: Mono-Therapy with Nivolumab (240 mg i.V. / Q2W x 8)~* If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W)~* If SD/PD: Nivolumab/Ipilimumab Boost 1+2-Combination Therapy (Nivo 3 mg/kg i.V. and Ipi 1 mg/kg i.V. / Q3W x 2)~* If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W)~* If SD/PD: Nivolumab/Ipilimumab Boost 3+4-Combination Therapy (Nivo 3 mg/kg i.V. and Ipi 1 mg/kg i.V. / Q3W x 2)~* If CR/PR/SD: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W)"

Trial Locations (35)

Unknown

Ordensklinikum Linz Barmherzige Schwestern, Linz

AKH Wien Universitätsklinik für Innere Medizin I, Vienna

ZNA Middelheim, Antwerp

CHR Verviers, Verviers

Fakultní nemocnice Hradec Králové, Hradec Králové

Fakultní nemocnice Olomouc, Olomouc

FN Motol, Prague

Všeobecné fakultní nemocnice, Prague

CHD Vendée, La Roche-sur-Yon

Centre Hôpitalier Lyon Sud, Lyon

Hôpitaux Universitaires de Strasbourg Hôpital Civil, Strasbourg

Institut Claudius Regaud, Toulouse

Institut Gustave Roussy, Villejuif

Charité Universitätsmedizin Berlin, Berlin

Universitätsklinikum Carl Gustav Carus, Dresden

Universitätsklinikum Düsseldorf, Düsseldorf

Universitätsklinikum, Düsseldorf

Universität des Saarlandes Medizinische Fakultät, Homburg/Saar

Azienda USL8 Arezzo U.O.C. Oncologia Medica, Arezzo

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

IRCCS Fondazione Policlinico San Matteo, Pavia

Azienda Ospedaliera San Camillo Forlanini, Roma

Policlinico Universitario A. Gemelli, Roma

Hospital de la Santa Creu i Sant Pau, Barcelona

Hospital 12 de Octubre, Madrid

Hospital Ramón y Cajal, Madrid

Hospital Universitario Central de Asturias, Oviedo

Complejo Hospitalario de Navarra, Pamplona

Hospital Universitario Marques de Valdecilla, Santander

Hospital Virgen del Rocio, Seville

Broomfield Hospital, Chelmsford

Charing Cross Hospital, London

Kent Oncology Centre, Maidstone

Royal Preston Hospital, Preston

07747

Universitätsklinikum Jena und Poliklinik für Urologie, Jena

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

AIO-Studien-gGmbH

OTHER