Spots Global Cancer Trial Database for IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma
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Trial Identification
Brief Title: IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma
Official Title: A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma
Study ID: NCT01265901
Conditions
Study Description
Brief Summary: The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib. Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters.
Detailed Description: This is a multicenter, open-label, randomized phase III study to investigate whether therapeutic vaccination with IMA901, a mult-peptide cancer vaccine (TUMAP), can prolong overall survival in patients with metastatic and/or locally advanced RCC when added to standard first-line therapy with sunitinib (primary endpoint). Secondary endpoints include a subgroup analysis of overall survival in patients who are positive for a prospectively defined primary biomarker signature (identified as being predictive for improved clinical outcome in IMA901-vaccinated patients in the previous phase II study), progression-free survival (PFS), best overall response, cellular immunomonitoring in a subset of patients, and safety. Safety analysis will be based on adverse events (AEs), physical examinations, vital signs, hematology, clinical chemistry, urinalysis and ECG changes. Further endpoints include subgroup analyses of overall survival in patients who are positive for further prospectively defined biomarkers (identified in the previous phase II study), and exploratory screening of new biomarkers (to be investigated in patients' blood and paraffin sections from tumor tissue) to predict better clinical outcome as response to vaccination with IMA901. Biomarker sets will not be used for patient selection in this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
Kaiser Permanente Oncology Hematology Clinic, Denver, Colorado, United States
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center, Washington, D.C., District of Columbia, United States
M.D. Anderson Cancer Center, Orlando, Florida, United States
The University of Chicago Medicine, Chicago, Illinois, United States
North Central Cancer Treatment Group, Illinois Cancer Care, Peoria, Illinois, United States
IU Simon Cancer Center, Indianapolis, Indiana, United States
Weinberg Cancer Institute at Franklin Hospital, Baltimore, Maryland, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Clinical Research Alliance, Lake Success, New York, United States
University of Cincinnati, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, United States
UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology, Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care, San Antonio, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Hôpital Saint André, Bordeaux, , France
Centre Francois Baclesse, Comite Urologie-Gynecologie, Caen Cedex, , France
CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire, Clermont Ferrand Cedex, , France
Hospital Européen Georges Pompidou, Service d'oncologie medicale, Paris, , France
Centre Rene Gauducheau, Service d'oncologie medicale, Saint-Herblain, , France
Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz, Berlin, , Germany
Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH, Bochum, , Germany
Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn, Bonn, , Germany
Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung), Essen, , Germany
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover, Hannover, , Germany
Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie, Heidelberg, , Germany
Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig, Leipzig, , Germany
Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München, Munich, , Germany
Urologische Klinik Dr. Castringius, München-Planegg, Planegg, , Germany
Klinikum St. Elisabeth Straubing GmbH, Straubing, , Germany
Klinik für Urologie, Universitätsklinikum Tübingen, Tübingen, , Germany
Klinik für Innere Medizin III, Hämatologie - Onkologie - Rheumatologie - Infektionskrankheiten, Universitätsklinikum Ulm, Ulm, , Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie, Villingen-Schwenningen, , Germany
Péterfy Utcai Hospital, Urology department, Budapest, , Hungary
Semmelweis University, Urology Clinic, Budapest, , Hungary
Urology Department, Bajcsy-Zsilinszky Hospital, Budapest, , Hungary
Uzsoki Utcai Hospital, Oncoradiology Center, Budapest, , Hungary
University of Debrecen, Faculty of Medicine, Institute of Oncology, Debrecen, , Hungary
University of Debrecen, Faculty of Medicine, Urology Clinic, Debrecen, , Hungary
Kenézy Hospital, Urology Department, Debrecen, , Hungary
Oncology Centre, Markhot Ferenc Training Hospital and Clinic, Eger, , Hungary
Pándy Kálmán County Hospital, Oncology and Radiotherapy Center, Gyula, , Hungary
Urology department, BAZ County Hospital, Miskolc, , Hungary
Urology Clinic, University of Pécs, Pécs, , Hungary
Oncology Therapy Clinic, University of Szeged, Szeged, , Hungary
County Oncology Centre, Hetényi Géza Hospital, Szolnok, , Hungary
Oncology Department, Zala County Hospital, Zalaegerszeg, , Hungary
Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica, Arezzo, , Italy
Centro di riferimento Oncologico di Aviano, Aviano, , Italy
Medical Oncology Unit, Policlinico Sant'Orsola Malpighi, Bologna, , Italy
Department of Oncology and Haematology, Division of Medical Oncology, University of Modena and Reggio Emilia, Modena, , Italy
Dipartimento di Oncologia, IRCCS Fondazione, Pavia, , Italy
Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia, Reggio Emilia, , Italy
Oncologia Medica, "Ospedale Infermi", Rimini, , Italy
Ospedale S.S Annunziata Sasari, Sassari, , Italy
IRCC-Istituto di Ricerca e Cura del Cancro, Torino, , Italy
University Medical Center St. Radboud Centraal, Department of Urology, Nijmegen, , Netherlands
University Hospital, UOS - Radiumhospital, Oslo, , Norway
Białostockie Centrum Onkologii, Białystok, , Poland
Prof. Franciszek Łukaszczyk Oncology Center, Bydgoszcz, , Poland
Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna, Dobra, , Poland
Wojewódzki Szpital Zespolony, Oncology Department, Elbląg, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Urologii, Gdańsk, , Poland
Chemotherapy Department Center of Oncology of the Lublin Region, Lublin, , Poland
Olsztyński Oncology Center "KOPERNIK", Olsztyn, , Poland
Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic, Poznań, , Poland
Private Outpatient Clinic MRUKMED, Rzeszów, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Szczecin, , Poland
Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic, Warsaw, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Magodent", Warsaw, , Poland
Urology and Urological Oncology Department and Clinic, Warsaw, , Poland
Fundeni Clinical Institute, Bucharest, , Romania
"Prof. Dr. Ioan Chiricuta" Oncology Institute, Cluj Napoca, , Romania
"Prof. Dr. Ioan Chiricuta" Oncology Institute, Cluj-Napoca, , Romania
Medisprof SRL, Cluj-Napoca, , Romania
SC Oncolab SRL, Craiova, , Romania
Emergency Clinical County Hospital Oradea, Oradea, , Romania
Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department, Targu-Mures, , Romania
State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary", Chelyabinsk, , Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan, Kazan, , Russian Federation
Institution of Russian Academy of Medical Science, "Russian Oncological Scientific Center named after N.N. Blokhin of Russian Academy of Medical Science", Moscow, , Russian Federation
Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation", Moscow, , Russian Federation
Moscow Hertsen Scientific Research Oncological Institute, Moscow, , Russian Federation
State Institution "City Clinical Hospital NO20", Moscow, , Russian Federation
Orenburg Regional Clinical Oncological Dispensary, Orenburg, , Russian Federation
State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav", Rostov-on-Don, , Russian Federation
State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary", Ryazan, , Russian Federation
Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC", Saratov, , Russian Federation
State Institution of Healthcare "Leningrad Regional Oncological Dispensary", St. Petersburg, , Russian Federation
Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02", St. Petersburg, , Russian Federation
Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary", St. Petersburg, , Russian Federation
Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation", St. Petersburg, , Russian Federation
Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation", St. Petersburg, , Russian Federation
Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology), St. Petersburg, , Russian Federation
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital", Yaroslavl, , Russian Federation
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center, Cambridge, , United Kingdom
Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital, Leeds, , United Kingdom
Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology, Manchester, , United Kingdom
Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology, Oxford, , United Kingdom
ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital, Preston, , United Kingdom
CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital, Southampton, , United Kingdom
Postgraduate Medical School, University of Surrey, Surrey, , United Kingdom
South West Wales Cancer Institute, Singleton Hospital, School of Medicine, Swansea, , United Kingdom
Contact Details
Name: Brian Rini, MD
Affiliation: Cleveland Clinic Taussig Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Tim Eisen, MD
Affiliation: Addenbrooke's Hospital University of Cambridge, UK
Role: PRINCIPAL_INVESTIGATOR
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