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TerminatedNCT02140138Updated Jun 13, 2016

An Open Label Randomised Trial of RNActive® Cancer Vaccine in High Risk and Intermediate Risk Patients With Prostate Cancer

A Phase 2 interventional study of CV9104 and needle free injection device (Tropis®) in Prostate Carcinoma, sponsored by CureVac. Terminated at 3 sites in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-13.

Sponsored by CureVac · Phase 2, Interventional, and Treatment

Why this study was terminated
Recruitment was terminated after enrolment of 35 instead of 36 evaluable patients for administrative reasons.
Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
Male
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Study summary

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.

Read the detailed description

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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Conditions studied

  • Prostate Carcinoma

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 35 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

CureVac is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Male aged ≥18 years

  2. Histologically confirmed 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.

Exclusion criteria

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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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Arm A (i.d. vaccinations with needle free injection device)

    Duration: Patients in Arm A will receive a total of 4 vaccinations with CV9104 in weeks 1, 2, 3 and 5. These patients will undergo radical prostatectomy at least 1 week but not later than 2 weeks after the 4th vaccination (week 6 or 7). After surgery high risk or very high risk patients will be offered to receive 2 additional vaccinations with CV9104 at week 8 and 10 post surgery. Administration: At each vaccination visit each of the 6 components of CV9104 vaccine will be injected individually, divided in two separate intradermal injections. These 12 Injections will be distributed over the 4 limbs (3 injections in each upper arm and thigh). Administration site: Skin of the lateral parts of the upper arms (over the deltoid regions) and the lateral part of the thighs. Dose: 2 x 80 μg mRNA per injection (2 x 100 μL), equals 160 μg mRNA per RNActive® drug product component

    Biological: CV9104 · Device: needle free injection device (Tropis®)

  • Experimental
    Arm B (i.d. vaccination by conventional injection)

    Duration: Patients in Arm B will receive a total of 4 vaccinations with CV9104 in weeks 1, 2, 3 and 5. These patients will undergo radical prostatectomy at least 1 week but not later than 2 weeks after the 4th vaccination (week 6 or 7). After surgery high risk or very high risk patients will be offered to receive 2 additional vaccinations with CV9104 at week 8 and 10 post surgery. Administration: At each vaccination visit each of the 6 components of CV9104 vaccine will be injected individually, divided in two separate intradermal injections. These 12 Injections will be distributed over the 4 limbs (3 injections in each upper arm and thigh). Administration site: Skin of the medial part of the upper arms and thigh Dose: 2 x 160 μg mRNA per injection (2 x 200 μL), equals 320 μg mRNA per RNActive® drug product component

    Biological: CV9104

  • Other
    Arm C (i.d. vaccination with needle free injection device)

    Duration: Patients in Arm C will receive no vaccination before radical prostatectomy. After surgery high risk or very high risk patients will be offered to receive 6 vaccinations with CV9104 at week 8, 9, 10, 12, 14 and 16 after surgery. Administration: At each vaccination visit each of the 6 components of CV9104 vaccine will be injected individually, divided in two separate intradermal injections. These 12 Injections will be distributed over the 4 limbs (3 injections in each upper arm and thigh). Administration site: Skin of the lateral parts of the upper arms (over the deltoid regions) and the lateral part of the thighs. Dose: 2 x 80 μg mRNA per injection (2 x 100 μL), equals 160 μg mRNA per RNActive® drug product component

    Biological: CV9104 · Device: needle free injection device (Tropis®)

Interventions

  • BiologicalCV9104
  • Deviceneedle free injection device (Tropis®)
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What researchers measure

Primary outcomes

  1. Induction of antigen-specific cellular and humoral immune response to the vaccine antigens.

    Time frame: Up to one week before the date of surgery.

Secondary outcomes

  1. 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)

  2. 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)

  3. Occurrence of treatment discontinuation due to adverse events

    Time frame: From time of first to last study treatment

  4. 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)

Other outcomes

  1. Assessment of immune cell infiltration, and gene expression profiles in prostatectomy tissue samples.

    Time frame: tissue collection at prostatectomy (week 6-7 in arm A and B, week 4-7 in arm C)

  2. Assessment of immune parameters and biomarkers in blood and exprimate urine

    Time frame: 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 post surgical visit (8 weeks after surgery; blood only) and in week 13 after surgery (in arm C, receiving vaccinations after surgery)

07

Study locations

3 sites
  • Nationales Zentrum für Tumorerkrankungen, Medizinische Onkologie
    Heidelberg, Baden-Württemberg 69120, Germany
  • Klinik für Urologie, Universitätsklinikum Tübingen
    Tübingen, Baden-Württemberg 72076, Germany
  • Klinikum rechts der Isar, Urologische Klinik und Poliklinik der Technischen Universität München
    München, Bayern 81675, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02140138
Lead sponsor
CureVac
Responsible party
Sponsor
First posted
May 16, 2014
Start date
Jun 2014
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Jun 13, 2016

Study contacts

Arnulf Stenzl, Prof. Dr. med.
principal investigator · Klinik für Urologie, Universitätsklinikum Tübingen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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