Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer

NCT01817738 | Terminated Phase 1 DMC

• 1 other identifier: CV-9104-004
• Study Type: interventional
• Target: 197
• Locations: 8 countries
• Sites: 48

Brief Summary

The purpose of this study is to determine whether the new RNActive®-derived prostate cancer vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant.

Conditions

Prostate Cancer

Keywords

Metastatic; Castrate-refractory

Outcome Measures

Primary Outcomes (2)

• Phase I (Safety Lead-In): Occurrence of dose-limiting toxicity (DLT) during the first 4 weeks of treatment (after administration of 3 vaccinations and after a 1 week observation period

  Safety Lead in Portion: Patients will receive CV9104 at a starting dose of 1920 µg in weeks 1, 2 and 3. Safety lead-in patients will be observed for DLTs until 1 week after Vaccination 3 (week 4). In case no DLTs will be observed vaccinations will continue in weeks 5, 7, 9, 12, 15, 18 and 24, then every 6 weeks for up to 12 months after the first vaccination and then every 3 months thereafter until one of the criteria for study treatment discontinuation is met

  Up to 4 weeks

• Phase II (Randomised Portion): Overall Survival from time of randomisation- up to 3.5-4 years.

  Overall survival will be assessed during the lifetime of the study

Secondary Outcomes (7)

• Progression free survival from date of randomisation

  Every 3 months for up to 2 years

• Progression free survival from start of first subsequent systemic therapy

  Every 6 months until 2 years

• Percent change to maximal and to minimal PSA from baseline and before start of first subsequent systemic cancer therapy and from start of first systemic therapy to end of first subsequent systemic therapy

  Every 3 months up to 2 years

• Cellular and humoral immune response rate against the 6 antigens encoded by CV9104

  Immune responses will be assessed at baseline, in week 6 and week 24 after start of vaccination

• Time to symptom progression based on FACT P score and subscores

  Assessments at baseline, weeks 5, 9,18, 24 and every 3 months for up to 2 years

Study Arms (2)

CV9104

ACTIVE COMPARATOR

CV9104 intradermal injection

Biological: CV9104

Placebo

PLACEBO COMPARATOR

Placebo intradermal injection

Biological: Placebo

Interventions

CV9104 BIOLOGICAL

Intradermal injection of CV9104

CV9104

Placebo BIOLOGICAL

Intradermal injection of placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, age ≥18 years
• Histologically confirmed castrate refractory metastatic adenocarcinoma of the prostate with progressive disease after surgical castration or during androgen suppression therapy including a GNRH agonist or antagonist and after at least 1 additional anti-hormonal manipulation; and serum testosterone level of \< 50 ng/dL or \< 1.7 nmol/L
• Progression will be confirmed either
• radiologically or
• by 2 consecutive rises of PSA, measured at least 1 week apart, resulting at least in a 50% increase over the nadir and a PSA \> 2 ng/mL.
• An antiandrogen withdrawal response must have been excluded after discontinuation of antiandrogen therapy for at least 6 weeks.
• Metastatic disease confirmed by imaging
• ECOG performance status 0 or 1

You may not qualify if:

• Previous immunotherapy for PCA (e.g. sipuleucel-T \[Provenge®\], experimental cancer vaccines or ipilimumab \[Yervoy®\]).
• Treatment with any investigational anticancer agents within 4 weeks prior to first dose of study drug
• Systemic treatment with immunosuppressive agents
• Active skin disease (atopic eczema, psoriasis) in the areas for vaccine injection (upper arms or thighs) preventing the administration of i.d. injections into areas of healthy skin.
• History of or current autoimmune disorders
• Primary or secondary immune deficiency.
• Seropositive for human immunodeficiency virus, hepatitis B virus (except after hepatitis B vaccination) or hepatitis C virus infection.
• Symptomatic congestive heart failure (New York Heart Association 3 or 4), unstable angina pectoris or myocardial infarction, significant cardiac arrhythmia, history of stroke or transient ischemic attack, all within 6 months prior to enrolment or severe hypertension according to WHO criteria or uncontrolled hypertension at the time of enrolment (systolic blood pressure ≥ 180 mm Hg)´
• Previous chemotherapy for metastatic PCA.
• Previous anti-hormonal treatment with abiraterone or any other investigational anti-hormonal treatment.
• Cancer-related pain requiring opioid narcotics within 28 days before enrolment or an average pain score of \> 3 on a visual analogue scale.
• Presence of visceral metastases.
• History of other malignancies other than PCA over the last 5 years (except basal cell carcinoma of the skin).

Sponsors & Collaborators

• CureVac: lead

Study Sites (48)

Krajská zdravotní, a.s. - Nemocnice Chomutov, o.z.Onkologické oddělení

Chomutov, 430 12, Czechia

Location

Fakultní nemocnice Olomouc, Urologická klinika

Olomouc, 779 00, Czechia

Location

Multiscan, a.s, Oddělení klinické a radiační onkologie

Pardubice, 532 03, Czechia

Location

Thomayerova nemocnice, Urologické oddělení

Prague, 140 59, Czechia

Location

Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem

Ústí nad Labem, 401 13, Czechia

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Universitätsklinikum Aachen Klinik für Urologie

Aachen, D-52074, Germany

Location

Vivantes Klinikum Am Urban Klinik für Urologie

Berlin, D-10967, Germany

Location

Medizinisches Zentrum Friedensplatz

Bonn, 53111, Germany

Location

Universitätsklinikum Dresden Klinik und Poliklinik für Urologie

Dresden, D-01307, Germany

Location

Chirurgische Universitätsklinik Freiburg Klinik für Urologie

Freiburg im Breisgau, D-79106, Germany

Location

Urologikum Hamburg

Hamburg, 22081, Germany

Location

Nationales Zentrum für Tumorerkrankungen Medizinische Onkologie

Heidelberg, D-69120, Germany

Location

Urologie am Nordplatz

Leipzig, 04105, Germany

Location

UMM Universitätsmedizin Mannheim

Mannheim, 68167, Germany

Location

Praxis Dr.schulze

Marklleeberg, 04416, Germany

Location

Urologische Klinik und Poliklinik der Technischen Universität München Klinikum Rechts der Isar

Munich, D-81675, Germany

Location

Universitätsklinikum Münster Klinik und Poliklinik für Urologie

Münster, D-48149, Germany

Location

Studienpraxis für Urologie

Nürtingen, D-72622, Germany

Location

Ortenau Klinikum Urologie und Kinderurologie

Offenburg, 77654, Germany

Location

Urologische Klinik Dr. Castingius München

Planegg, 82152, Germany

Location

Universitätsklinik für Urologie

Tübingen, D-72076, Germany

Location

Medica Pro Familia Krakow

Krakow, 30-002, Poland

Location

Centrum Urologiczne Sp. z o.o.

Mysłowice, 41-400, Poland

Location

Centralny Szpital Kliniczny MSWiA, Klinika Onkologii I Hematologii

Warsaw, 02-507, Poland

Location

Szpital Sw. Elżbiety - Mokotowskie Centrum Medyczne

Warsaw, 02-616, Poland

Location

Instytut M. Curie-Skłodowskiej Centrum Onkologii

Warsaw, 02-781, Poland

Location

NZOZ Magodent, Centrum Medyczne Ostrobramska, Oncologii Klinicznej i Chemíoterapii

Warsaw, 04-125, Poland

Location

Profesorskie Centrum Medyczne OPTIMUM Wrocław

Wroclaw, 50-421, Poland

Location

Szpital Uniwersytecki, Katedra i Klinika Urologii i Onkologii Urologicznej

Wroclaw, 50-556, Poland

Location

Hospital de Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal (CIOCC)

Madrid, 28050, Spain

Location

Hospital Clínico Virgen de la Victoria Campus Universitario de Teatinos s/n

Málaga, 29010, Spain

Location

Clínica Universitaria de Navarra Departamento de Oncología

Pamplona, 31008, Spain

Location

Complejo Hospitalario Universitario Santiago Departamento de Oncología

Santiago de Compostela, 15703, Spain

Location

Instituto Valenciano de Oncología Unidad de Investigación Clínica

Valencia, 46009, Spain

Location

"Sahlgrenska Universitetssjukhuset Urologmottagningen

Gothenburg, 41345, Sweden

Location

Skånes Universitetssjukhus Malmö Urologmottagningen

Malmo, 20502, Sweden

Location

Universitetssjukhuset Örebro Urologmottagningen

Örebro, 70185, Sweden

Location

Karolinska Universitetssjukhuset Solna Urologiska kliniken

Stockholm, 17176, Sweden

Location

Akademiska sjukhuset Urologmottagningen

Uppsala, 75185, Sweden

Location

Universitätsspital Basel Medizinische Onkologie

Basel, 4031, Switzerland

Location

Kantonsspital Graubünden Department Innere Medizin Hämatologie und Onkologie

Chur, 7000, Switzerland

Location

CHUV Centre Pluridisciplinaire d'Oncologie

Lausanne, 1011, Switzerland

Location

Kantonsspital St. Gallen Department Innere Medizin Hämatologie Medizinische Onkologie

Sankt Gallen, 9007, Switzerland

Location

Royal Free Hospital

London, NW32QC, United Kingdom

Location

Nottingham City Hospital Department of Oncology

Nottingham, NG5 1PB, United Kingdom

Location

Clatterbridge Cancer Centre

Wirral, Merseyside, CH63 4JY, United Kingdom

Location

York Hospital

York, Y03 8HE, United Kingdom

Location

Related Links

• Click here for more information about CureVac

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnulf Stenzl, Prof. Dr.

  University Hospital of Tübingen; Dept. of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: March 25, 2013
• Study Start: August 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 17, 2017

Record last verified: 2016-04

Locations

CZ (5); GB (4); FR (1); ES (5); DE (16); CH (4); SE (5); PL (8)