Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomised, Double-blind, Placebo-controlled, Phase I/II Trial of RNActive®-Derived Cancer Vaccine (CV9104) in Asymptomatic or Minimally Symptomatic Patients With Metastatic Castrate-refractory Prostate Cancer|
- Phase I (Safety Lead-In): Occurence of dose-limiting toxicity (DLT) during the first 4 weeks of treatment (after administration of 3 vaccinations and after a 1 week observation period [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
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
- 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 ] [ Designated as safety issue: No ]
- Progression free survival from date of randomisation [ Time Frame: Every 3 months for up to 2 years ] [ Designated as safety issue: No ]
- Progression free survival from start of first subsequent systemic therapy [ Time Frame: Every 6 months until 2 years ] [ Designated as safety issue: No ]
- Percent change to maximal and to minimal PSA from baseline and before start of first subsequent systemic cancer therapy [ Time Frame: Every 3 months up to 2 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Absolute change from baseline FACT P score and subscores [ Time Frame: Assessments at baseline, weeks 5,9,18,24 and every 3 months for up to 2 years ] [ Designated as safety issue: No ]
- Absolute change 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 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Active Comparator: CV9104
CV9104 intradermal injection
Intradermal injection of CV9104
Placebo Comparator: Placebo
Placebo intradermal injection
Intradermal injection of placebo
The study is the first clinical study with the new prostate cancer vaccine CV9104. This vaccine is composed of 6 RNActive-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.
|Contact: Arnulf Stenzl, Prof.||+49-7071-29 email@example.com|
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|Principal Investigator:||Arnulf Stenzl, Prof. Dr.||Universityhospital of Tübingen; Dept. of Urology|