Trial document

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Trial Description

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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

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Trial Acronym


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URL of the Trial


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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00005373
  •   2013/10/17
  •   2013/02/08
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01817738  (
  •   CV-9104-004  (CureVac GmbH)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Biological: CV9104
  •   Biological: Placebo
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  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   I-II
  •   [---]*
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Primary Outcome

- 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

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Czech Republic
  •   France
  •   Germany
  •   Poland
  •   Spain
  •   Sweden
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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  •   2012/08/31
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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


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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).

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  • start of 1:1-Block address primary-sponsor
    • CureVac AG
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    • University Hospital of Tübingen; Dept. of Urology
    • Arnulf Stenzl, Prof. Dr. 
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    • University Hospital of Tübingen; Dept. of Urology
    • Arnulf Stenzl, Prof. Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in and DRKS are not identical. Therefore the data import from required adjustments. For full details please see the DRKS FAQs .
  •   13
  •   2016/04/10

* This entry means the parameter is not applicable or has not been set.