Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006424

Trial Description

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Title

An Open Label Randomised Phase II Trial of RNActive® Cancer Vaccine (CV9104) in High Risk and Intermediate Risk Patients With 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 evaluate the induction of immune responses against CV9104
administered by conventional intradermal injection or with a needle-free intradermal
injection device and to assess the safety and tolerability of CV9104 administered by
conventional intradermal injection versus injection with a needle-free intradermal injection
device versus no injection.

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Brief Summary in Scientific Language

This study is the second clinical trial of the RNActive® vaccine. It is composed of 6
RNActive® drug product components, coding for 6 antigens that are overexpressed in PCA
compared to healthy tissue. Each of the 6 prostate specific antigens that are encoded by
CV9104 are capable of inducing adaptive immunity.

Needle-free injection systems, like the Tropis™device for i.d. injection, overcome the
disadvantages related to needle- and syringe-based i.d. injections. Tropis™ is currently
used in different vaccine clinical trials around the world. The use of Tropis™ for i.d.
delivery of CV9104 has been approved by BfArM.

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Organizational Data

  •   DRKS00006424
  •   2014/11/21
  •   2014/04/07
  •   no
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Secondary IDs

  •   2013-004489-32 
  •   NCT02140138  (ClinicalTrials.gov)
  •   CV-9104-007  (CureVac GmbH)
  •   2013-004489-32 
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Health Condition or Problem studied

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

  •   Biological: CV9104
  •   Device: needle free injection device (Tropis™)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Induction of antigen-specific cellular and humoral immune response to the vaccine antigens.; time frame: Up to one week before the date of surgery.

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Secondary Outcome

- Incidence and severity of adverse device effects, adverse events and laboratory abnormalities, graded according to NCI-CTCAE version 4.0 criteria; time frame: From ICF signature till end of study (max. up to week 20 after first study treatment in arm A and B and up to week 26 after first study treatment in arm C)
- Occurrence of serious adverse events; time frame: From ICF signature till end of study (max. up to week 20 after first study treatment in arm A and B and up to week 26 after first study treatment in arm C)
- Occurrence of treatment discontinuation due to adverse events; time frame: From time of first to last study treatment
- Change in PSA serum levels during the presurgical period and, in patients receiving postsurgical vaccinations, change in PSA during the postsurgical period; time frame: At screening, at baseline (week 1), at the last presurgical visit (week 6 in arm A and B, week 3-6 in arm C), at the first postsurgical visit (8 weeks after surgery) and at the end of study (max. up to week 21 in arm A and B and up to week 27 in arm C)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/06/30
  •   36
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Male aged ≥18 years

2. Histologically confirmed localised adenocarcinoma of the prostate with at least one
of the following criteria for intermediate to high risk disease:

- Gleason Score 7-10

- Serum PSA > 10 ng/mL

- cT2b-c / cT3a without tumor fixation to adjacent organs

3. Absence of very high risk or metastatic disease (i.e. cT3b-T4 N0 or any T, N1 or M1)
confirmed by EITHER CT or MRI of the abdomen and pelvis (in patients with a Gleason
score ≥ 8 or a clinical stage T3) and bone scintigraphy (in patients with a PSA of ≥
10 ng/mL, a Gleason score ≥ 8, a clinical stage T3 or bone pain or other symptoms of
metastatic disease)

4. Patient is physically fit and eligible for radical prostatectomy based on best
clinical evidence and has already decided to undergo radical prostatectomy after
discussion of potential alternative treatment options.

5. ECOG 0 or 1

6. No prior treatment for prostate cancer including prior surgery (including TURP),
pelvic lymph node dissection, radiation therapy, antihormonal therapy or chemotherapy

7. Adequate organ function:

- Bone marrow function: hemoglobin ≥ 12 g/dL; white blood cell count (WBC) ≥ 3.0 x
109/L; lymphocyte count ≥ 1.0 x 109/L; absolute neutrophil count (ANC) ≥ 1.5 x
109/L; platelet count ≥ 150 x 109/L

- Hepatic: AST, ALT and GGT ≤ 2.5 times upper limit of normal (ULN); bilirubin ≤
1.5 x ULN

- Renal: creatinine ≤ 2 mg/dL and creatinine clearance ≥ 45 mL/min/1.73 m2

8. Fertile men and their female partners must use a highly effective method of
contraception resulting in a low failure rate (i.e. less than 1% per year) when used
consistently and correctly. Those methods include implants, injectables, combined
oral contraceptives, some intrauterine devices (IUDs) or abstinence. The
contraception should be applied from enrollment until 4 weeks after the last
vaccination.

9. Written informed consent must be obtained prior to conducting any study-specific
procedures.

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Exclusion Criteria

1. Concurrent treatment with systemic steroids or other immunosuppressive agents [except
topical (inhaled, topical, nasal) and replacement therapy for adrenal insufficiency]
should be strictly avoided throughout the study, concomitant treatment with
immunomodulating agents including herbal remedies (e.g. mistletoe extract) has to be
avoided during study treatment and must be discontinued at least 28 days prior to the
start of treatment

2. Previous therapies with investigational anticancer agents including cancer vaccines
or other cancer immunotherapies

3. Prior splenectomy

4. Prior allogeneic bone marrow transplant

5. History of autoimmune disorders such as sarcoidosis, lupus erythematosus, rheumatoid
arthritis, glomerulonephritis or systemic vasculitis (except autoimmune thyroiditis
with only thyroid hormone replacement and stable disease > 1 year)

6. Primary or secondary immune deficiency

7. Seropositive for HIV, HBV (except after Hep B vaccination) or HCV infection

8. History of other malignancies over the last 5 years (except adequately treated basal
cell or squamous cell carcinoma of the skin)

9. Uncontrolled medical condition considered as high risk for the treatment with an
investigational drug including unstable diabetes mellitus, symptomatic congestive
heart failure (NYHA 3 and 4); coronary heart disease with unstable angina pectoris,
history of myocardial infarction, or coronary artery intervention (PTCA, stenting)
within 6 months prior to enrolment; significant cardiac arrhythmia, history of stroke
or transient ischemic attack. Severe hypertension according to WHO criteria or
systolic blood pressure ≥ 180 mmHg at the time of enrolment.

10. History of seizures, encephalitis or multiple sclerosis

11. History of inflammatory bowel disease or Crohn´s disease or ulcerative colitis

12. Active drug abuse or chronic alcoholism

13. Active skin disease (atopic eczema, psoriasis) in the areas for vaccine injection
preventing the i.d. administration of study product into areas of healthy skin

14. Allergies to any component of the study drug including known allergy to protamine
sulphate (e.g. allergy to protamine containing insulins) or fish allergy.

15. Prior vasectomy

16. Known type I allergy to β-lactam antibiotics

17. Active infections (including acute prostatitis) requiring anti-infectious therapy at
the time of enrolment: leucocytosis ≥ 9000/μL; CRP elevation ≥ 2.5 times upper limit
of normal or leucocyturia of ≥ 75 cells/μl (equals ≥ grade 2+ on two consecutive
Combur® urinalysis specimen)

18. Uncontrolled urinary retention or hydronephrosis

19. Inability to provide informed consent due to mental impairment

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Addresses

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    • CureVac AG
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    • Klinik für Urologie, Universitätsklinikum Tübingen
    • Arnulf Stenzl, Prof. Dr. med. 
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    • Arnulf Stenzl, Prof. Dr. med. 
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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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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


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