Spots Global Cancer Trial Database for Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)
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Trial Identification
Brief Title: Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)
Official Title: An Open-label, Randomized, Controlled, Multicenter, Phase II Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy, Compared to Sunitinib Post-nephrectomy in Metastatic Renal Cell Carcinoma Patients
Study ID: NCT02432846
Conditions
Study Description
Brief Summary: The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients.
Detailed Description: Patients, all planned for nephrectomy, will be stratified according to the Heng risk criteria (high risk patients vs. intermediate risk patients) and randomized in a 2:1 ratio to receive Intuvax (INN: ilixadencel)+ Sunitinib or Sunitinib alone. Two doses of Intuvax (INN: ilixadencel) will be administered in to the primary tumour before nephrectomy. The control group will be scheduled for nephrectomy directly. All patients will start Sunitinib treatment 5-8 weeks after operation. Results from the phase I study, together with the results reported in the literature on the use of autologous dendritic cells (DCs) in combination with Sunitinib encourage Immunicum aktiebolag (AB) to further investigate the possibility of exploiting Intuvax (INN: ilixadencel) 10 million cells/dose when combined with Sunitinib for the treatment of mRCC patients.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Illinois, Chicago, Illinois, United States
Rush University, Chicago, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
Health Partners Institute, Saint Paul, Minnesota, United States
Duke Cancer Institute, Durham, North Carolina, United States
University Hospital Olomouc, Olomouc, , Czechia
Centre Hospitalier Universitaire d'Angers, Angers Cedex 9, , France
Centre Hospitalier Universitaire de Toulouse-Hôpital Rangueil, Toulouse, , France
University of Debrecen, Debrecen, , Hungary
Szent-Györgyi Albert Klinikai Központ, Szeged, , Hungary
Pauls Stradins Clinical University Hospital, Riga, , Latvia
Riga East Clinical University Hospital, Riga, , Latvia
Niepubliczny Zakład Opieki Zdrowotnej Vesalius Sp. z o.o., Kraków, , Poland
Wojewodzki Szpital Specjalistyczny, Lublin, , Poland
Military Institute of Medicine, Warsaw, , Poland
Mazowiecki Szpital Onkologiczny, Wieliszew, , Poland
Hospital Universitari Germans Trias i Pujol, Badalona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, , Spain
Hospital Universitari Parc Tauli, Sabadell, , Spain
Sahlgrenska University Hospital, Göteborg, , Sweden
Karolinska University Hospital, Huddinge, , Sweden
Umeå University Hospital, Umeå, , Sweden
Uppsala University Hospital, Uppsala, , Sweden
The Churchill Hospital, Oxford, , United Kingdom
Royal Preston Hospital, Preston, , United Kingdom
Contact Details
Name: Börje Ljungberg, MD, Prof
Affiliation: Umeå University Hospital
Role: PRINCIPAL_INVESTIGATOR
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