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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 1/Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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.


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

Key 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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

Up to 4 weeks

Safety Issue:


Principal Investigator

Arnulf Stenzl, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universityhospital of Tübingen; Dept. of Urology


Czech Republic: State Institute for Drug Control

Study ID:




Start Date:

August 2012

Completion Date:

December 2016

Related Keywords:

  • Prostate Cancer
  • Metastatic
  • Castrate-refractory
  • Prostatic Neoplasms