Sökning: WFRF:(Gallardo E.) >
Ilixadencel, a Cell...
Ilixadencel, a Cell-based Immune Primer, plus Sunitinib Versus Sunitinib Alone in Metastatic Renal Cell Carcinoma: A Randomized Phase 2 Study
-
- Lindskog, Magnus (författare)
- Uppsala universitet,Karolinska Institutet,Cancerfarmakologi och beräkningsmedicin,Experimentell och klinisk onkologi,Uppsala Univ, Uppsala Univ Hosp, Dept Immunol Genet & Pathol, Entrance 100-101, S-751 85 Uppsala, Sweden.
-
- Laurell, A. (författare)
- Department of Oncology, Akademiska University Hospital, Uppsala, Sweden,Akadem Univ Hosp, Dept Oncol, Uppsala, Sweden.
-
- Kjellman, A. (författare)
- Karolinska Institutet,Karolinska Univ Hosp, Karolinska Inst, CLINTEC, Dept Urol, Stockholm, Sweden.
-
visa fler...
-
- Melichar, B. (författare)
- Department of Urology and Urological Oncology, Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego, Lublin, Poland,Wojewodzki Szpital Specjalist im Stefana Kardynauc, Dept Urol & Urol Oncol, Lublin, Poland.
-
- Rey, P. M. (författare)
- Hospital de la Santa Creu i Sant Pau, Barcelona, Spain,Hosp Santa Creu i Sant Pau, Barcelona, Spain.
-
- Zielinski, H. (författare)
- Clinical Urology, Military Institute of Medicine, Warsaw, Poland,Mil Inst Med, Clin Urol, Warsaw, Poland.
-
- Villacampa, F. (författare)
- Urology Service, Hospital Unversitario, 12 Octubre, Madrid, Spain,Hosp Unversitario 12 Octubre, Urol Serv, Madrid, Spain.
-
- Bigot, P. (författare)
- Department of Urology, Centre Hospitalier Universitaire d'Angers, Angers Cedex, France,Ctr Hospitalier Univ Angers, Dept Urol, Angers, France.
-
- Zoltan, B. (författare)
- Szent-Györgyi Albert Klinikai Központ, Szegedi Tudomanyegyetem Altalanos Ovostudomanyi Kar Urologiai Klinika, Szeged, Hungary,Royal Preston Hosp, Rosemere Canc Ctr, Preston, Lancs, England.
-
- Parikh, O. (författare)
- Rosemere Cancer Centre, Royal Preston Hospital, UK, Preston, United Kingdom,Hosp Univ Puerta Hierro Majadahonda, Serv Urol, Madrid, Spain.
-
- Alba, D. V. (författare)
- Servicio de Urología, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain,Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Oncol, Gothenburg, Sweden.
-
- Jellvert, Åsa (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden,Univ Debrecen, Med Sch, Dept Urol, Debrecen, Hungary.
-
- Flasko, T. (författare)
- Department of Urology, Medical School, University of Debrecen, Debrecen, Hungary,Univ Autonoma Barcelona, Parc Tauli Hosp Universitari, Inst Invest Innovacio Parc Tauli i I3PT, Oncol Dept, Sabadell, Spain.
-
- Gallardo, E. (författare)
- Oncology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, Spain,Hosp Clin Barcelona, Dept Urol, Barcelona, Spain.
-
- Caparros, M. J. R. (författare)
- Department of Urology, Hospital Clínic Barcelona, Barcelona, Spain,Pauls Stradins Clin Univ Hosp, Oncol Clin, Riga, Latvia.
-
- Purkalne, G. (författare)
- Oncology Clinic, Pauls Stradins Clinical University Hospital, Rīga, Latvia,Immunicum AB, Stockholm, Sweden.
-
- Suenaert, P. (författare)
- Immunicum AB, Stockholm, Sweden,Uppsala Univ, Dept Immunol Genet & Pathol, Sect Clin Immunol, Uppsala, Sweden.
-
- Karlsson-Parra, Alex (författare)
- Uppsala universitet,Klinisk immunologi,Science for Life Laboratory, SciLifeLab,Umeå Univ, Dept Surg & Perioperat Sci, Urol & Androl, Umeå, Sweden.
-
- Ljungberg, Börje, Professor, 1949- (författare)
- Umeå universitet,Urologi och andrologi,Szent Gyorgy Albert Klinika Kozpont, Szeged Tudomanyegyetem Altalan Ovostudomany Kar Ur, Szeged, Hungary.
-
Jellvert, D (författare)
-
visa färre...
-
(creator_code:org_t)
- Elsevier BV, 2022
- 2022
- Engelska.
-
Ingår i: European Urology Open Science. - : Elsevier BV. - 2666-1691 .- 2666-1683. ; 40, s. 38-45
- Relaterad länk:
-
https://doi.org/10.1...
-
visa fler...
-
https://umu.diva-por... (primary) (Raw object)
-
https://uu.diva-port... (primary) (Raw object)
-
https://gup.ub.gu.se...
-
https://doi.org/10.1...
-
https://urn.kb.se/re...
-
http://kipublication...
-
https://urn.kb.se/re...
-
visa färre...
Abstract
Ämnesord
Stäng
- Background: The prognosis of patients with synchronous metastatic renal cell carcinoma (mRCC) is poor. Whereas single-agent tyrosine kinase inhibition (TKI) is clearly insufficient, the effects can be enhanced by combinations with immune checkpoint inhibitors. Innovative treatment options combining TKI and other immune-stimulating agents could prove beneficial. Objective: To evaluate the clinical effects on metastatic disease when two doses of allogeneic monocyte-derived dendritic cells (ilixadencel) are administrated intratumorally followed by nephrectomy and treatment with sunitinib compared with nephrectomy and sunitinib monotherapy, in patients with synchronous mRCC. Design, setting, and participants: A randomized (2:1) phase 2 multicenter trial enrolled 88 patients with newly diagnosed mRCC to treatment with the combination ilixadencel/sunitinib (ILIXA/SUN; 58 patients) or sunitinib alone (SUN; 30 patients).Outcome measurements and statistical analysis: The primary endpoints were 18mo survival rate and overall survival (OS). A secondary endpoint was objective response rate (ORR) assessed up to 18 mo after enrollment. Statistic evaluations included Kaplan-Meier estimates, log-rank tests, Cox regression, and stratified Cochran-Mantel-Haenszel tests.Results and limitations: The median OS was 35.6 mo in the ILIXA/SUN arm versus 25.3 mo in the SUN arm (hazard ratio 0.73, 95% confidence interval 0.42-1.27; p = 0.25), while the 18-mo OS rates were 63% and 66% in the ILIXA/SUN and SUN arms, respectively. The confirmed ORR in the ILIXA/SUN arm were 42.2% (19/45), including three patients with complete response, versus 24.0% (six/25) in the SUN arm (p = 0.13) without complete responses. The study was not adequately powered to detect modest differences in survival. Conclusions: The study failed to meet its primary endpoints. However, ilixadencel in combination with sunitinib was associated with a numerically higher, nonsignificant, confirmed response rate, including complete responses, compared with sunitinib monotherapy.Patient summary: We studied the effects of intratumoral vaccination with ilixadencel followed by sunitinib versus sunitinib only in a randomized phase 2 study. The combination treatment showed numerically higher numbers of confirmed responses, suggesting an immunologic effect.(c) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- Allogeneic dendritic cells
- Ilixadencel
- Intratumoral administration
- Metastatic renal cell carcinoma
- Off the shelf
- Phase 2 trial
- Randomized
- Sunitinib
- european association
- urology guidelines
- combination
- nivolumab
- Urology & Nephrology
- Allogeneic dendritic cells
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Lindskog, Magnus
-
Laurell, A.
-
Kjellman, A.
-
Melichar, B.
-
Rey, P. M.
-
Zielinski, H.
-
visa fler...
-
Villacampa, F.
-
Bigot, P.
-
Zoltan, B.
-
Parikh, O.
-
Alba, D. V.
-
Jellvert, Åsa
-
Flasko, T.
-
Gallardo, E.
-
Caparros, M. J. ...
-
Purkalne, G.
-
Suenaert, P.
-
Karlsson-Parra, ...
-
Ljungberg, Börje ...
-
Jellvert, D
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Urologi och njur ...
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Cancer och onkol ...
- Artiklar i publikationen
-
European Urology ...
- Av lärosätet
-
Göteborgs universitet
-
Umeå universitet
-
Karolinska Institutet
-
Uppsala universitet