A Phase I/II, Clinical Trial to Evaluate the Safety and Immune Activation of the Combination of DCVAC/PCa, and ONCOS-102, in Men With Advanced Metastatic Castration-resistant Prostate Cancer.

This clinical trial is to evaluate the safety of the combination of DCVAC/PCa with ONCOS-102 in men with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either hormones (e.g. abiraterone and enzalutamide) or chemotherapy.
Male patients with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either All patients must have at least one readily accessible soft tissue/nodal tumor lesion (for intra-tumoral application of ONCOS-102 and biopsy.

Start Date23 May 2018

Sponsor / Collaborator

Excoso as

NCT02111577

/ CompletedPhase 3

A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men With Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.

Start Date26 May 2014

Sponsor / Collaborator

Excoso as

NCT02137746

/ CompletedPhase 2

Open-label, One-arm, Multi-centre Phase II Clinical Trial Treated With Second Cycle of Active Cellular Immunotherapy With DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy Without Objective Progression

The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.

Start Date01 Dec 2013

Sponsor / Collaborator

Excoso as

100 Clinical Results associated with Stapuldencel-T

100 Translational Medicine associated with Stapuldencel-T

100 Patents (Medical) associated with Stapuldencel-T

Literatures (Medical) associated with Stapuldencel-T

31 Dec 2022·OncoImmunology

Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines

Article

Author: Sojka, Ludek ; Spisek, Radek ; Hensler, Michal ; Schoenenberger, Andreu ; Horvath, Rudolf ; Garg, Abhishek D. ; Rozkova, Daniela ; Drozenova, Jana ; Pasulka, Josef ; Lanickova, Tereza ; Podrazil, Michal ; Fucikova, Jitka ; Brtnicky, Tomas ; Hraska, Marek ; Coosemans, An ; Holicek, Peter ; Laco, Jan ; Kasikova, Lenka ; Vergote, Ignace ; Rob, Lukas ; Hrnciarova, Tereza ; Halaska, Michal J. ; Ryska, Ales ; Bartunkova, Jirina ; Rakova, Jana ; Hongyan, Guo ; Sochorova, Klara ; Cibula, David ; Kadlecova, Pavla

Dendritic cells (DCs) have received considerable attention as potential targets for the development of novel cancer immunotherapies. However, the clinical efficacy of DC-based vaccines remains suboptimal, largely reflecting local and systemic immunosuppression at baseline. An autologous DC-based vaccine (DCVAC) has recently been shown to improve progression-free survival and overall survival in randomized clinical trials enrolling patients with lung cancer (SLU01, NCT02470468) or ovarian carcinoma (SOV01, NCT02107937), but not metastatic castration-resistant prostate cancer (SP005, NCT02111577), despite a good safety profile across all cohorts. We performed biomolecular and cytofluorometric analyses on peripheral blood samples collected prior to immunotherapy from 1000 patients enrolled in these trials, with the objective of identifying immunological biomarkers that may improve the clinical management of DCVAC-treated patients. Gene signatures reflecting adaptive immunity and T cell activation were associated with favorable disease outcomes and responses to DCVAC in patients with prostate and lung cancer, but not ovarian carcinoma. By contrast, the clinical benefits of DCVAC were more pronounced among patients with ovarian carcinoma exhibiting reduced expression of T cell-associated genes, especially those linked to T_H2-like signature and immunosuppressive regulatory T (T_REG) cells. Clinical responses to DCVAC were accompanied by signs of antitumor immunity in the peripheral blood. Our findings suggest that circulating signatures of antitumor immunity may provide a useful tool for monitoring the potency of autologous DC-based immunotherapy.

15 Jul 2022·Clinical Cancer Research

An Autologous Dendritic Cell Vaccine Promotes Anticancer Immunity in Patients with Ovarian Cancer with Low Mutational Burden and Cold Tumors

Article

Author: Rakova, Jana ; Sojka, Ludek ; Galluzzi, Lorenzo ; Cibula, David ; Ryska, Ales ; Halaska, Michael J. ; Kasikova, Lenka ; Spisek, Radek ; Drozenova, Jana ; Hensler, Michal ; Praznovec, Ivan ; Coosemans, An ; Galon, Jérôme ; Dundr, Pavel ; Fucikova, Jitka ; Rozkova, Daniela ; Rob, Lukas ; Pasulka, Josef ; Fredriksen, Tessa ; Lanickova, Tereza ; Hrnciarova, Tereza ; Hraska, Marek ; Sochorova, Klara ; Brtnicky, Tomas ; Laco, Jan ; Vergote, Ignace ; Bartunkova, Jirina

AbstractPurpose:The successful implementation of immune checkpoint inhibitors (ICI) in the clinical management of various solid tumors has raised considerable expectations for patients with epithelial ovarian carcinoma (EOC). However, EOC is poorly responsive to ICIs due to immunologic features including limited tumor mutational burden (TMB) and poor lymphocytic infiltration. An autologous dendritic cell (DC)-based vaccine (DCVAC) has recently been shown to be safe and to significantly improve progression-free survival (PFS) in a randomized phase II clinical trial enrolling patients with EOC (SOV01, NCT02107937).Patients and Methods:We harnessed sequencing, flow cytometry, multispectral immunofluorescence microscopy, and IHC to analyze (pretreatment) tumor and (pretreatment and posttreatment) peripheral blood samples from 82 patients enrolled in SOV01, with the aim of identifying immunologic biomarkers that would improve the clinical management of patients with EOC treated with DCVAC.Results:Although higher-than-median TMB and abundant CD8+ T-cell infiltration were associated with superior clinical benefits in patients with EOC receiving standard-of-care chemotherapy, the same did not hold true in women receiving DCVAC. Conversely, superior clinical responses to DCVAC were observed in patients with lower-than-median TMB and scarce CD8+ T-cell infiltration. Such responses were accompanied by signs of improved effector functions and tumor-specific cytotoxicity in the peripheral blood.Conclusions:Our findings suggest that while patients with highly infiltrated, “hot” EOCs benefit from chemotherapy, women with “cold” EOCs may instead require DC-based vaccination to jumpstart clinically relevant anticancer immune responses.

01 Apr 2022·JAMA OncologyQ1 · MEDICINE

The VIABLE Phase 3 Randomized Clinical Trial

Q1 · MEDICINE

Article

Author: Daugaard, Gedske ; Buchler, Tomas ; Higano, Celestia S. ; Prausova, Jana ; Williamson, Stephen ; Hammerer, Peter ; Bloom, Stuart ; Sousa, Nuno ; Wuelfing, Christian ; Gil, Thierry ; McClay, Edward ; Vaishampayan, Ulka ; Rubio, Gustavo ; Olmos, David ; Castellano, Daniel ; Feyerabend, Susan ; Ritter, Manuel ; Merseburger, Axel ; Harshman, Lauren ; Haberkorn, Brigitte ; Gunuganti, Vijay ; von Schmeling, Ingo Kausch ; Fernandes, Isabel ; Chapado, Manuel Sanchez ; Shtivelband, Mikhail ; Damjanoski, Ilija ; Bryce, Alan ; Gerritsen, Winald ; Oh, William ; Bahl, Amit ; Walsh, William ; Clarkson, David ; Filipovic, Zoran ; Ferrau, Francesco ; Jarolim, Ladislav ; Brezovsky, Marek ; Schraml, Jan ; Berg, Arthur S. ; Mikuláš, Juraj ; Fratino, Lucia ; Schnadig, Ian ; Gartrell, Benjamin ; van de Eertwegh, Fons ; Sharma, Sanjay ; Rodemer, Gerald ; Singal, Rakesh ; Bilusic, Marijo ; Lumen, Nicolaas ; Khoo, Vincent ; Prokhorov, Alexander ; Sousa, Gabriela ; Keck, Bastian ; Jansa, Jan ; Scheiner, Tomas ; Beeker, Aart ; Stenzl, Arnulf ; Hussain, Arif ; Herden, Jan ; Le Moulec, Sylvestre ; Hruby, Stephan ; Gaur, Rakesh ; Elliott, Tony ; Machiels, Jean-Pascal ; Fleming, Mark ; Puente, Javier ; Vanella, Paola ; Jaeger, Elke ; Karaszewska, Boguslawa ; Jhangiani, Haresh ; Fricke, Harald ; Reyes, Evangeline ; Cesas, Alvydas ; Burmester, Martin ; Boreu, Pablo Gajete ; Nieboer, Peter ; Tulyte, Skaiste ; Breza, Jan ; Grimm, Marc-Oliver ; Karlin, Gary ; Asadauskiene, Jolita ; Purkalne, Gunta ; Vilarino-Varela, Maria ; Dawson, Nancy ; Hwang, Clara ; Staroslawska, Elzbieta ; Gandhi, Jitendra ; McCroskey, Robert ; Fornara, Paolo ; Cortesi, Enrico ; Krainer, Michael ; Ahlgren, Johan ; Karim, Nagla ; Janciauskiene, Rasa ; Cvetkovic, Bora ; Babovic, Nada ; Aapro, Matti ; Mincik, Ivan ; Pedley, Ian ; Kucuk, Omer ; Nordquist, Luke ; Tomova, Antoaneta ; Goncalves, Frederico ; Hussain, Syed ; Rodrigues, Tânia ; Arranz, Jose Angel ; Appleman, Leonard ; Shore, Neal ; Samal, Vladimir ; Koleva, Marchela ; Drabek, Martin ; Deplanque, Gael ; van den Berg, Pieter ; Spisek, Radek ; Duclos, Brigitte ; Montesa, Alvaro ; Choi, Brian ; Corman, John ; Meran, Johannes ; Bartunkova, Jirina ; Agrawal, Apurv ; Sokol, Roman ; Law, Amy ; Dzamic, Zoran ; Polyakov, Sergey ; Agarwala, Sanjiv ; Minchev, Velko ; Zarkar, Anjali ; Cheung, Eric ; Belkoff, Laurence ; Csöszi, Tibor ; Beer, Tomasz M. ; Burke, John ; Hajek, Jaroslav ; Kukielka-Budny, Bozena ; Ackaert, Koen ; Pápai, Zsuzsanna ; Kurth, Karl-Heinz ; Roumeguere, Thierry ; Stadler, Walter ; Agrawal, Manish ; Melichar, Bohuslav ; Vogelzang, Nicholas J. ; Winter, Alexander ; Sikora-Kupis, Bozena ; Korolkiewicz, Roman P. ; Juretic, Antonio ; Wirth, Manfred ; Pandha, Hardev ; Delonchamps, Nicolas ; Wiechno, Pawel ; Fijuth, Jacek ; Mazhar, Danish ; Miller, Kurt ; Redfern, Charles ; Dimitrov, Borislav ; Sartor, Alton ; Vojnovic, Zeljko ; Slater, Dennis ; Kadlecova, Pavla ; Bodoky, György ; SotoParra, Hector ; Hauke, Ralph ; Fröbe, Ana ; Polee, Marco ; Gajdos, Milan ; Passalacqua, Rodolfo ; Poiesz, Bernard ; Kindlova, Eva ; Zemanova, Milada ; Oudard, Stéphane ; Flaig, Thomas ; Mellado, Begona ; Böszörményi-Nagy, Géza ; Calvo, Virginia ; Boegemann, Martin ; Zdrojowy, Romuald ; Maio, Michele ; Culine, Stéphane ; Mayer, Tina ; Chodacka, Martina ; Karlsson, Erika Thellenberg

IMPORTANCEDCVAC/PCa is an active cellular immunotherapy designed to initiate an immune response against prostate cancer.OBJECTIVETo evaluate the efficacy and safety of DCVAC/PCa plus chemotherapy followed by DCVAC/PCa maintenance treatment in patients with metastatic castration-resistant prostate cancer (mCRPC).DESIGN, SETTING, AND PARTICIPANTSThe VIABLE double-blind, parallel-group, placebo-controlled, phase 3 randomized clinical trial enrolled patients with mCRPC among 177 hospital clinics in the US and Europe between June 2014 and November 2017. Data analyses were performed from December 2019 to July 2020.INTERVENTIONSEligible patients were randomized (2:1) to receive DCVAC/PCa (add-on and maintenance) or placebo, both in combination with chemotherapy (docetaxel plus prednisone). The stratification was applied according to geographical region (US or non-US), prior therapy (abiraterone, enzalutamide, or neither), and Eastern Cooperative Oncology Group performance status (0-1 or 2). DCVAC/PCa or placebo was administered subcutaneously every 3 to 4 weeks (up to 15 doses).MAIN OUTCOMES AND MEASURESThe primary outcome was overall survival (OS), defined as the time from randomization until death due to any cause, in all randomized patients. Survival was compared using 2-sided log-rank test stratified by geographical region, prior therapy with abiraterone and/or enzalutamide, and Eastern Cooperative Oncology Group performance status.RESULTSA total of 1182 men with mCRPC (median [range] age, 68 [46-89] years) were randomized to receive DCVAC/PCa (n = 787) or placebo (n = 395). Of these, 610 (81.8%) started DCVAC/PCa, and 376 (98.4%) started placebo. There was no difference in OS between the DCVAC/PCa and placebo groups in all randomized patients (median OS, 23.9 months [95% CI, 21.6-25.3] vs 24.3 months [95% CI, 22.6-26.0]; hazard ratio, 1.04; 95% CI, 0.90-1.21; P = .60). No differences in the secondary efficacy end points (radiological progression-free survival, time to prostate-specific antigen progression, or skeletal-related events) were observed. Treatment-emergent adverse events related to DCVAC/PCa or placebo occurred in 69 of 749 (9.2%) and 48 of 379 (12.7%) patients, respectively. The most common treatment-emergent adverse events (DCVAC/PCa [n = 749] vs placebo [n = 379]) were fatigue (271 [36.2%] vs 152 [40.1%]), alopecia (222 [29.6%] vs 130 [34.3%]), and diarrhea (206 [27.5%] vs 117 [30.9%]).CONCLUSIONS AND RELEVANCEIn this phase 3 randomized clinical trial, DCVAC/PCa combined with docetaxel plus prednisone and continued as maintenance treatment did not extend OS in patients with mCRPC and was well tolerated.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT02111577.

100 Deals associated with Stapuldencel-T

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 3	Sweden	Excoso as	26 May 2014
Metastatic castration-resistant prostate cancer	Phase 3	United Kingdom	Excoso as	26 May 2014
Metastatic castration-resistant prostate cancer	Phase 3	Serbia	Excoso as	26 May 2014
Metastatic castration-resistant prostate cancer	Phase 3	Lithuania	Excoso as	26 May 2014
Metastatic castration-resistant prostate cancer	Phase 3	Czechia	Excoso as	26 May 2014
Metastatic castration-resistant prostate cancer	Phase 3	Austria	Excoso as	26 May 2014
Metastatic castration-resistant prostate cancer	Phase 3	Hungary	Excoso as	26 May 2014
Metastatic castration-resistant prostate cancer	Phase 3	Denmark	Excoso as	26 May 2014
Metastatic castration-resistant prostate cancer	Phase 3	Slovakia	Excoso as	26 May 2014
Prostatic Cancer	Phase 3	Turkey	Excoso as	02 Apr 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02111577 (VIABLE, Pubmed) Manual	Phase 3	Metastatic castration-resistant prostate cancer	1,182	Docetaxel+Prednisone+DCVAC/PCa	(klfsvromlz) = oifeurinfh wxmiybjfuz (qwjmfzcwro, 21.6 - 25.3) View more	Negative	10 Feb 2022
				Docetaxel+Prednisone+Placebo	(klfsvromlz) = udzyrzmrnq wxmiybjfuz (qwjmfzcwro, 22.6 - 26.0) View more
NCT02111577 (VIABLE, CTgov)	Phase 3	Metastatic castration-resistant prostate cancer	1,182	DCVAC/PCa (DCVAC/PCa With Standard of Care Chemotherapy)	emdhoqvvsn(levxxqjaap) = iolfqkevfd orgchalnnn (ztlfpnvqdx, oxdvreksoa - mxxtqxmfoq) View more	-	06 Apr 2021
				Placebo (Placebo With Standard of Care Chemotherapy)	emdhoqvvsn(levxxqjaap) = cxxdqylkgg orgchalnnn (ztlfpnvqdx, fwoqzdrbes - houfsrfily) View more
ASCO2014	Phase 1/2	Castration-Resistant Prostatic Cancer	25	DCVAC/PCa	(ztowgxwpxe) = nzvkeczjls mzngbhzgpq (yptnbhcqth ) View more	-	20 May 2014

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