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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
197
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
Time frame: Up to 4 weeks
Phase II (Randomised Portion): Overall Survival from time of randomisation- up to 3.5-4 years.
Time frame: Overall survival will be assessed during the lifetime of the study
Progression free survival from date of randomisation
Time frame: Every 3 months for up to 2 years
Progression free survival from start of first subsequent systemic therapy
Time frame: 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
Time frame: Every 3 months up to 2 years
Cellular and humoral immune response rate against the 6 antigens encoded by CV9104
Time frame: 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
Time frame: Assessments at baseline, weeks 5, 9,18, 24 and every 3 months for up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 38 more locations
Absolute change and area under the curve from baseline EQ-5D score and pain sub-score
Time frame: Assessments at baseline, weeks 5, 9,18, 24 and thereafter every 3 months for up to 2 years
Progression free survival from randomisation until second progression on first subsequent therapy
Time frame: Every 3 and 6 months up to 2 years