Clinical trial NCT02111577: Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Castration-resistant Prostate Cancer
Keywords: Immunotherapy
Metastatic
Castration-resistant
Prostate cancer
Biological
Vaccine
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-11
Enrollment: 1182
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This was a randomized, double blind, placebo-controlled, multicenter, international, parallel-group phase III study. Patients with metastatic castration-resistant prostate cancer who were candidates to receive standard of care first-line chemotherapy with docetaxel plus prednisone were randomized 2:1 into one of two arms: an investigational arm (DCVAC/PCa) and a control arm (placebo) in addition to chemotherapy (docetaxel plus prednisone).

Eligibility criteria: Inclusion criteria:

* Male 18 years and older.
* Histologically or cytologically confirmed prostate adenocarcinoma.
* Presence of skeletal, or soft-tissue/visceral/nodal metastases according to one of the following criteria:

  * Confirmed pathological fracture related to the disease OR
  * Confirmation of distant bone and/or soft-tissue and/or visceral metastases on CT or MRI scan or bone scintigraphy OR
  * Positive pathology report of metastatic lesion
* Disease progression despite androgen-deprivation therapy (ADT) as indicated by:

  * Prostate-specific antigen (PSA) increase that is ≥ 2 ng/mL and ≥ 25% above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed and which is confirmed by a second value 1 or more weeks later OR
  * Progression of measurable lymph nodes (short axis ≥ 15 mm) or visceral lesion measurable per RECIST v1.1 criteria, confirmation by an independent review facility (IRF) required OR
  * Two or more new lesions appearing on bone scan/imaging compared with a previous scan (confirmation by IRF required)
* Maintenance of castrate conditions: patients, who have not had a surgical orchiectomy, must continue with hormone therapy with gonadotropin releasing hormone/ luteinizing hormone-releasing hormone (GnRH/LHRH) agonists or antagonists to reach levels of serum testosterone of ≤ 1.7 nmol/L (50 ng/dL). The duration of the castration period must be at least 4 months before screening as evidenced by combination of clinical/laboratory data (see section 6.8.1).
* Laboratory criteria:

  * White blood cells (WBC) greater than 4,000/mm3 (4.0 x109/L)
  * Neutrophil count greater than 1,500/mm3 (1.5 x109/L).
  * Hemoglobin of at least 10 g/dL (100 g/L).
  * Platelet count of at least 100,000/mm3 (100 x 109/L).
  * Total bilirubin within normal limits (benign hereditary hyperbilirubinemias, e.g. Gilbert's syndrome, are permitted).
  * Serum alanine aminotransferase, aspartate aminotransferase, and creatinine \< 1.5x times the upper limit of normal (ULN).
* Life expectancy of at least 6 months based on Investigator's judgment.
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
* At least 4 weeks after surgery or radiotherapy before randomization.
* A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy before randomization.
* Recovery from primary local surgical treatment, radiotherapy or orchiectomy before randomization.
* Signed informed consent including patient's ability to comprehend its contents.

Exclusion criteria:

* Confirmed brain and/or leptomeningeal metastases (other visceral metastases are acceptable).
* Current symptomatic spinal cord compression requiring surgery or radiation therapy.
* Prior chemotherapy for prostate cancer.
* Patient co-morbidities:

  * Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone).
  * HIV positive, human T-lymphotropic virus positive.
  * Active hepatitis B (active hepatitis B), active hepatitis C (HCV), active syphilis.
  * Evidence of active bacterial, viral or fungal infection requiring systemic treatment.
  * Clinically significant cardiovascular disease including:

    * symptomatic congestive heart failure.
    * unstable angina pectoris.
    * serious cardiac arrhythmia requiring medication.
    * uncontrolled hypertension.
    * myocardial infarction or ventricular arrhythmia or stroke within a 6 months before screening, known left ventricular ejection fraction (LVEF) \< 40% or serious cardiac conduction system disorders, if a pacemaker is not present.
  * Pleural and pericardial effusion of any NCI CTCAE grade.
  * Peripheral neuropathy having a NCI CTCAE ≥ grade 2.
  * History of malignant disease (with the exception of non-melanoma skin tumors) in the preceding five years.
  * Active autoimmune disease requiring treatment.
  * History of severe forms of primary immune deficiencies.
  * History of anaphylaxis or other serious reaction following vaccination.
  * Known hypersensitivity to any constituent of the DCVAC/PCa or placebo product.
  * Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator's opinion, would prevent participation in the trial.
* Systemic corticosteroids at doses greater than 40 mg hydrocortisone daily or equivalent for any reason other than treatment of PCa within 6 months before randomization.
* Ongoing systemic immunosuppressive therapy for any reason.
* Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumor-focused treatment performed on the day of randomization (except for GnRH/LHRH agonists or antagonists) to exclude possible anti-androgen withdrawal response. This criterion is not applicable to subjects who have never responded to anti-androgen treatment, as there is no risk of anti-androgen withdrawal response.
* Treatment with immunotherapy against PCa within 6 months before randomization.
* Treatment with radiopharmaceutical within 8 weeks before randomization.
* Participation in a clinical trial using non-immunological experimental therapy within 4 weeks before randomization.
* Participation in a clinical trial using immunological experimental therapy (e.g., monoclonal antibodies, cytokines or active cellular immunotherapies) within 6 months before randomization.
* Refusal to sign the informed consent.

Primary outcomes:
measure: Overall Survival, Intention-to-treat Population
timeFrame: From randomization to death due to any cause, up to 58 months
Secondary outcomes:
measure: Overall Survival, Per Protocol Population
timeFrame: From randomization to death due to any cause, up to 58 months
measure: Overall Survival, Intention-to-treat Population, Abiraterone as Prior Therapy
timeFrame: From randomization to death due to any cause, up to 58 months
measure: Overall Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy
timeFrame: From randomization to death due to any cause, up to 58 months
measure: Overall Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide
timeFrame: From randomization to death due to any cause, up to 58 months
measure: Radiological Progression-free Survival, Intention-to-treat Population
timeFrame: Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months
measure: Radiological Progression-free Survival, Per Protocol Population
timeFrame: Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months
measure: Time to PSA Progression, Intention-to-treat Population
timeFrame: Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months
measure: Time to PSA Progression, Per Protocol Population
timeFrame: Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months
measure: Time to First Skeletal-related Event, Intention-to-treat Population
timeFrame: Time from randomization to the date of the first skeletal-related event, up to 58 months
measure: Time to First Skeletal-related Event, Per Protocol Population
timeFrame: Time from randomization to the date of the first skeletal-related event, up to 58 months
measure: Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population
timeFrame: Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months
measure: Time to Radiological Progression or Skeletal-related Event, Per Protocol Population
timeFrame: Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months
measure: Proportion of Patients With Skeletal-related Events, Intention-to-treat Population
timeFrame: From randomization to the end of the study, up to 57 months
measure: Proportion of Patients With Skeletal-related Events, Per Protocol Population
timeFrame: From randomization to the end of the study, up to 57 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Corona
country: United States
facility: Compassionate Care Research Group, Inc.
state: California
city: Encinitas
country: United States
facility: California Cancer Associates for Research and Excellence
state: California
city: Fountain Valley
country: United States
facility: Compassionate Care Research Group, Inc.
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Los Angeles
country: United States
facility: Hao Wei Zhang, MD, LLC
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group
state: California
city: Riverside
country: United States
facility: Compassionate Care Research Group, Inc.
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Whittier
country: United States
facility: Oncology Institute of Hope and Innovation
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Norwich
country: United States
facility: Eastern CT Hematology and Oncololgy Associates
state: Connecticut
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Miami
country: United States
facility: Univ. of Miami, Sylvester Comprehensive Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Cancer Center & Medical Pavilion
state: Kansas
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Cancer Center
state: Maryland
city: Rockville
country: United States
facility: Associates In Oncology/Hematology,P.C
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: Umass Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Omaha
country: United States
facility: GU Research Network
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Research Centers of Nevada
state: Nevada
city: Brick
country: United States
facility: New Jersey Hematology Oncology Associates
state: New Jersey
city: Lawrenceville
country: United States
facility: Premier Urology Associates, LLC / AdvanceMed Research
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cincinnati
country: United States
facility: UC Health University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern Pennsylvania
state: Pennsylvania
city: Easton
country: United States
facility: Cancer Care Associates St. Luke's University and Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: Associates in Oncology & Hematology
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Houston
country: United States
facility: UT Health, Internal Medicine, Division of Oncology
state: Texas
city: Plano
country: United States
facility: Texas Health Physicians Group
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Network of South Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Hematology Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Mary Babb Randolph Cancer Center
state: West Virginia
city: Salzburg
country: Austria
facility: Universitatsklinikum fur Urologie und Andrologie
city: Wien
country: Austria
facility: Krankenhaus Barmherzige Brueder
city: Wien
country: Austria
facility: AKH Universitatskrankenhaus Wien
city: Lesnoy
country: Belarus
facility: N.N. Alexandrov National Research Center
city: Minsk
country: Belarus
facility: Minsk City Oncological Hospital
city: Brussels
country: Belgium
facility: Clinique d'Oncologie Medicale Institut Jules Bordet
city: Brussels
country: Belgium
facility: Erasme Hospital- Urologie
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc- Urologie
city: Gent
country: Belgium
facility: Urologie UZ Gent
city: Turnhout
country: Belgium
facility: Urology Department St. Elizabeth Ziekenhuis
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active treatment in Oncology
city: Plovdiv
country: Bulgaria
facility: Central Oncology Hospital
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center
city: Sofia
country: Bulgaria
facility: Multifunctional Hospital for Active Treatment Serdika
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Oncology Diseases
city: Varaždin
country: Croatia
facility: General Hospital Varazdin
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Center Sisters of Charity
city: Chomutov
country: Czechia
facility: Onkologicke centrum, Nemocnice Chomutov
city: Hradec Kralove
country: Czechia
facility: Klinika onkologie a radioterapie, Fakultni nemocnice
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava, urologicke oddeleni
city: Liberec
country: Czechia
facility: Urologicke oddeleni, Krajska nemocnice
city: Olomouc
country: Czechia
facility: Onkologicka klinika, Fakultni nemocnice
city: Ostrava-Poruba
country: Czechia
facility: Klinika onkologicka, Fakultni nemocnice
city: Prague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Prague
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Prague
country: Czechia
facility: Thomayerova nemocnice
city: Prague
country: Czechia
facility: Fakultni nemocnice v Motole
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni, urologicke oddeleni
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Paris Cedex 15
country: France
facility: HEGP medical oncology
city: Paris
country: France
facility: St-Louis IDF Medical Oncology
city: Paris
country: France
facility: Hopital St. Joseph
city: Paris
country: France
facility: Hospital Cochin, Service de Urologie
city: Saint Mandé
country: France
facility: HIA Begin
city: Strasbourg
country: France
facility: Hospital Civil de Strasbourg
city: Berlin
country: Germany
facility: Charite Universitatsklinikum Berlin
city: Braunschweig
country: Germany
facility: Stadtisches Klinikum Braunschweig
city: Dresden
country: Germany
facility: Universtatsklinikum Carl Gustav Carus
city: Erlangen
country: Germany
facility: Waldkrankenhaus St. Marien
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Halle
country: Germany
facility: Universitatsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Asklepios-Klinik Hamburg-Altona
city: Hannover
country: Germany
facility: Vinzenkrankenhaus Hannover
city: Hannover
country: Germany
facility: Medizinische hochschule Hannover
city: Jena
country: Germany
facility: Universitatskinikum Jena
city: Köln
country: Germany
facility: Klinik und Poliklinik Urologie
city: Mannheim
country: Germany
facility: Universitatsmedizin Mannheim
city: Münster
country: Germany
facility: Universtatsklinikum Munster
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AOR
city: Tübingen
country: Germany
facility: Universitastsklinikum Tubingen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Westerstede
country: Germany
facility: Ammerland Klinik fur Urologie
city: Wilhelmshaven
country: Germany
facility: Praxigemeinschaft fur Onkologie und Urologie
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinsky Korhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei
city: Aviano
country: Italy
facility: CRO Aviano
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele
city: Cremona
country: Italy
facility: A.O. Istituti Ospitalieri di Cremona
city: Cuneo
country: Italy
facility: A.O. Santa Croce e Carle Oespedale
city: Rome
country: Italy
facility: Universita di Roma Sapienza
city: Sienna
country: Italy
facility: Azienda Ospedialiera Universitaria Senese
city: Taormina
country: Italy
facility: Oncologia medica Ospedale S. Vincenzo
city: Riga
country: Latvia
facility: Paula Stradina Kliniska Universitates slimnica
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Science Oncology Institute
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Amsterdam
country: Netherlands
facility: VU medical Center
city: Assen
country: Netherlands
facility: Wilhemina Ziekenhuis
city: Hilversum
country: Netherlands
facility: Tergooi Ziekenhuizen
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Leeuwarden
country: Netherlands
facility: Oncology Medisch Centrum
city: Nijmegen
country: Netherlands
facility: UMC St.Radboud
city: Rotterdam
country: Netherlands
facility: Oncology Maasstad Ziekenhuis
city: Konin
country: Poland
facility: Przychodnia Lekarska (KOMED)
city: Lodz
country: Poland
facility: Szpital im M.Kopernika
city: Warszawa
country: Poland
facility: INSTYTUT im. Marii Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Centrum Medyczne Ostrobramska
city: Wroclaw
country: Poland
facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, E.P.E - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E
city: Belgrade
country: Serbia
facility: CHC Zemun
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology of Serbia
city: Belgrade
country: Serbia
facility: KBC Bezanijska Kosa
city: Bratislava
country: Slovakia
facility: J.Breza MEDICAL s.r.o.
city: Bratislava
country: Slovakia
facility: Urologicka ambulancia CUIMED s.r.o.
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Nitra
country: Slovakia
facility: Urologicka ambulancia Uroexam, spol. s r.o.
city: Piestany
country: Slovakia
facility: UROX s.r.o.
city: Presov
country: Slovakia
facility: Urocentrum MILAB s.r.o.
city: Trencin
country: Slovakia
facility: Privatna urologicka ambulancia
city: Zilina
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Zilina
city: Alcalá de Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranón
city: Madrid
country: Spain
facility: Hosp. Clinico Univ. San Carlos
city: Madrid
country: Spain
facility: Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal (CIOCC)
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Universitario Quiron Madrid
city: Umeå
country: Sweden
facility: University Hospital Umeå, Dept Oncology
city: Örebrö
country: Sweden
facility: Örebro University Hospital
city: Bebington
country: United Kingdom
facility: The Clatterbridge Cancer Centre
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Guildford
country: United Kingdom
facility: St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care, Freeman Hospital
Study officials:
affiliation: US Oncology Research/Comprehensive Cancer Centers of Nevada
name: Nicholas J. Vogelzang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hensler M, Rakova J, Kasikova L, Lanickova T, Pasulka J, Holicek P, Hraska M, Hrnciarova T, Kadlecova P, Schoenenberger A, Sochorova K, Rozkova D, Sojka L, Drozenova J, Laco J, Horvath R, Podrazil M, Hongyan G, Brtnicky T, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Garg AD, Cibula D, Bartunkova J, Spisek R, Fucikova J. Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines. Oncoimmunology. 2022 Jul 22;11(1):2101596. doi: 10.1080/2162402X.2022.2101596. eCollection 2022.
citation: Vogelzang NJ, Beer TM, Gerritsen W, Oudard S, Wiechno P, Kukielka-Budny B, Samal V, Hajek J, Feyerabend S, Khoo V, Stenzl A, Csoszi T, Filipovic Z, Goncalves F, Prokhorov A, Cheung E, Hussain A, Sousa N, Bahl A, Hussain S, Fricke H, Kadlecova P, Scheiner T, Korolkiewicz RP, Bartunkova J, Spisek R; VIABLE Investigators. Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):546-552. doi: 10.1001/jamaoncol.2021.7298.