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

NCT ID: NCT01817738

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2017-01-31

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.

Detailed Description

The study is the first clinical study with the new prostate cancer vaccine CV9104. This vaccine is composed of 6RNActive®-based compounds, each encoding for an antigen that is overexpressed in prostate cancer compared to healthy tissues. RNActive®-based vaccines are a novel class of vaccines based on messenger RNA.

The study is a double-blind randomized placebo-controlled phase I/II trial in men with asymptomatic- minimally symptomatic metastatic castrate-refractory prostate cancer.

The phase 1 (safety lead- in) part of the trial has the primary objective to assess the safety of CV9104 and to determine the dose for the randomized phase II part.

The primary objective of the phase II part is to compare overall survival in patients treated with CV9104 compared to patients treated with placebo.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CV9104

CV9104 intradermal injection

Group Type: ACTIVE_COMPARATOR

CV9104

Intervention Type: BIOLOGICAL

Intradermal injection of CV9104

Placebo

Placebo intradermal injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Intradermal injection of placebo

Interventions

CV9104

Intradermal injection of CV9104

Intervention Type: BIOLOGICAL

Placebo

Intradermal injection of placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male, age ≥18 years

2. 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.

3. Metastatic disease confirmed by imaging

4. ECOG performance status 0 or 1

Exclusion Criteria

1. Previous immunotherapy for PCA (e.g. sipuleucel-T [Provenge®], experimental cancer vaccines or ipilimumab [Yervoy®]).

2. Treatment with any investigational anticancer agents within 4 weeks prior to first dose of study drug

3. Systemic treatment with immunosuppressive agents

4. 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.

5. History of or current autoimmune disorders

6. Primary or secondary immune deficiency.

7. Seropositive for human immunodeficiency virus, hepatitis B virus (except after hepatitis B vaccination) or hepatitis C virus infection.

8. 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)´

9. Previous chemotherapy for metastatic PCA.

10. Previous anti-hormonal treatment with abiraterone or any other investigational anti-hormonal treatment.

11. Cancer-related pain requiring opioid narcotics within 28 days before enrolment or an average pain score of > 3 on a visual analogue scale.

12. Presence of visceral metastases.

13. History of other malignancies other than PCA over the last 5 years (except basal cell carcinoma of the skin).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

CureVac

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnulf Stenzl, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Tübingen; Dept. of Urology

Locations

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

Chomutov, , Czechia

Fakultní nemocnice Olomouc, Urologická klinika

Olomouc, , Czechia

Multiscan, a.s, Oddělení klinické a radiační onkologie

Pardubice, , Czechia

Thomayerova nemocnice, Urologické oddělení

Prague, , Czechia

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

Ústí nad Labem, , Czechia

Institut Gustave Roussy

Villejuif, , France

Universitätsklinikum Aachen Klinik für Urologie

Aachen, , Germany

Vivantes Klinikum Am Urban Klinik für Urologie

Berlin, , Germany

Medizinisches Zentrum Friedensplatz

Bonn, , Germany

Universitätsklinikum Dresden Klinik und Poliklinik für Urologie

Dresden, , Germany

Chirurgische Universitätsklinik Freiburg Klinik für Urologie

Freiburg im Breisgau, , Germany

Urologikum Hamburg

Hamburg, , Germany

Nationales Zentrum für Tumorerkrankungen Medizinische Onkologie

Heidelberg, , Germany

Urologie am Nordplatz

Leipzig, , Germany

UMM Universitätsmedizin Mannheim

Mannheim, , Germany

Praxis Dr.schulze

Marklleeberg, , Germany

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

Munich, , Germany

Universitätsklinikum Münster Klinik und Poliklinik für Urologie

Münster, , Germany

Studienpraxis für Urologie

Nürtingen, , Germany

Ortenau Klinikum Urologie und Kinderurologie

Offenburg, , Germany

Urologische Klinik Dr. Castingius München

Planegg, , Germany

Universitätsklinik für Urologie

Tübingen, , Germany

Medica Pro Familia Krakow

Krakow, , Poland

Centrum Urologiczne Sp. z o.o.

Mysłowice, , Poland

Centralny Szpital Kliniczny MSWiA, Klinika Onkologii I Hematologii

Warsaw, , Poland

Szpital Sw. Elżbiety - Mokotowskie Centrum Medyczne

Warsaw, , Poland

Instytut M. Curie-Skłodowskiej Centrum Onkologii

Warsaw, , Poland

NZOZ Magodent, Centrum Medyczne Ostrobramska, Oncologii Klinicznej i Chemíoterapii

Warsaw, , Poland

Profesorskie Centrum Medyczne OPTIMUM Wrocław

Wroclaw, , Poland

Szpital Uniwersytecki, Katedra i Klinika Urologii i Onkologii Urologicznej

Wroclaw, , Poland

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

Madrid, , Spain

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

Málaga, , Spain

Clínica Universitaria de Navarra Departamento de Oncología

Pamplona, , Spain

Complejo Hospitalario Universitario Santiago Departamento de Oncología

Santiago de Compostela, , Spain

Instituto Valenciano de Oncología Unidad de Investigación Clínica

Valencia, , Spain

"Sahlgrenska Universitetssjukhuset Urologmottagningen

Gothenburg, , Sweden

Skånes Universitetssjukhus Malmö Urologmottagningen

Malmo, , Sweden

Universitetssjukhuset Örebro Urologmottagningen

Örebro, , Sweden

Karolinska Universitetssjukhuset Solna Urologiska kliniken

Stockholm, , Sweden

Akademiska sjukhuset Urologmottagningen

Uppsala, , Sweden

Universitätsspital Basel Medizinische Onkologie

Basel, , Switzerland

Kantonsspital Graubünden Department Innere Medizin Hämatologie und Onkologie

Chur, , Switzerland

CHUV Centre Pluridisciplinaire d'Oncologie

Lausanne, , Switzerland

Kantonsspital St. Gallen Department Innere Medizin Hämatologie Medizinische Onkologie

Sankt Gallen, , Switzerland

Royal Free Hospital

London, , United Kingdom

Nottingham City Hospital Department of Oncology

Nottingham, , United Kingdom

Clatterbridge Cancer Centre

Wirral, Merseyside, , United Kingdom

York Hospital

York, , United Kingdom

Countries

Czechia; France; Germany; Poland; Spain; Sweden; Switzerland; United Kingdom

Related Links

http://www.curevac.de

Click here for more information about CureVac

Other Identifiers

CV-9104-004

Identifier Type: -

Identifier Source: org_study_id