Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer
|Study Design:||Allocation: Randomized
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): 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 [ Time Frame: Up to 4 weeks ]
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 ]
- 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 ]
- 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 ]
|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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01817738
Show 48 Study Locations
|Principal Investigator:||Arnulf Stenzl, Prof. Dr.||University Hospital of Tübingen; Dept. of Urology|