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Hormonal Refractory Prostate CancerPhase 1/2NCT00831467

Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease

A Phase 1/2 study testing CV9103 in people with Hormonal Refractory Prostate Cancer, run by CureVac at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the efficacy and safety of a new vaccine in hormone refractory prostate cancer Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Hormonal Refractory Prostate Cancer
What is being tested?
CV9103
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
12 sitesin 2 countries
Study dates
Jan 2009to Sep 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation
  • Male and age ≥ 18 years (Phase I and II) and ≤ 75 years (Phase II only)
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate, Gleason Score available
  • Patients must have been treated with hormonal therapy and may have been treated with surgery and/ or radiation therapy
  • Progressive disease as defined by hormone-refractoriness and rise in PSA:
  • Hormone-refractoriness: Defined by a rise in PSA and/or RECIST-based progression of evaluable lesions, and/or increased number of hotspots on a bone scan, while the patient has a castrated level of testosterone. This castrated level may have been obtained by orchiectomy, or LH-RH analog ± antiandrogen. Antiandrogen must be discontinued for at least 4 weeks before study entry to exclude a withdrawal effect.
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  • Rise in PSA: Defined by a rise in PSA levels at three consecutive time points (PSA rise over nadir, separated by > 1 week, PCWG2 criteria)
  • Presence of metastatic disease is acceptable
  • ECOG performance status of 0 to 1
  • Life expectancy > 12 months as assessed by the investigator
  • Adequate organ function :
  • Bone marrow function: Hemoglobin ≥ 10 g/dL; Leukocytes ≥ 3000/µL; Lymphocytes ≥ 1000/µL; Absolute neutrophil count ≥ 1500/µL; Platelet count ≥ 100000/µL Hepatic: AST and ALT ≤ 2.5 times upper limit of normal (ULN); Bilirubin ≤ 1.5 ULN Renal: Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60mL/min
  • Concomitant LH-RH therapy continuation is acceptable
  • May have had local palliative radiotherapy for bone metastasis involving less than 25% of bone marrow
  • Patients requiring bisphosphonates at the time of registration into the trial are eligible (therapy initiated at least 28 days prior to first study treatment administration) and must be continued at a constant level during the study period.
  • Patients of child-producing potential must agree to use contraception while enrolled in the study and for one month after the last immunization.

Who cannot join

  • Other histologic type of prostate cancer (transitional cell, small cell or squamous cell cancer)
  • Symptomatic brain metastasis or leptomeningeal involvement
  • Patients having received or currently receiving chemo- or biological therapy for prostate cancer
  • Symptomatic congestive heart failure (NYHA 3 and 4); unstable angina pectoris; significant cardiac arrhythmia
  • Pulmonary disease causing dyspnea or fatigue during normal activity
  • History of seizures, encephalitis or multiple sclerosis
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  • Inflammatory bowel disease e.g. Crohn's disease or ulcerative colitis; active diverticulitis
  • Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy, (e.g. sarcoidosis, lupus erythematosus, rheumatoid arthritis, glomerulonephritis or systemic vasculitis), excepting autoimmune thyroiditis with only thyroid hormone replacement and stable disease > 1 year
  • Primary or secondary immune deficiency
  • History of allergy requiring medication
  • Active drug abuse or chronic alcoholism
  • Clinically significant active infections
  • Seropositive for HIV, HBV or HCV
  • History of other malignancies over the last 5 years (except basal cell carcinoma of the skin)
  • Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, known ascites and/or pleural effusion, symptomatic pleural effusion treated by puncture
  • Renal insufficiency requiring dialysis
  • Patients being committed to an institution by virtue of an order issued either by the judicial or the administrative authorities

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Germany11 sites

  • Universitätsklinikum Aachen, Urologische Klinik

    Aachen, 52074

  • Charité Universitätsmedizin Berlin, Urologische Klinik u. Hochschulambulanz

    Berlin, 12200

  • Universitätsklinikum Carl Gustav Carus der TU Dresden, Klinik und Poliklinik für Urologie

    Dresden, 01307

  • Universitätsklinikum Essen, Klinik und Poliklinik für Urologie, Uroonkologie und Kinderurologie

    Essen, 45122

  • Klinikum der JWG-Universität, Klinik für Urologie und Kinderurologie

    Frankfurt am Main, 60590

  • Universitätsklinikum Freiburg, Abteilung Urologie

    Freiburg im Breisgau, 79106

  • UKSH Campus Lübeck, Klinik und Poliklinik fur Urologie

    Lübeck, 23538

  • Johannes-Gutenberg-Universität Mainz, Urologische Klinik und Poliklinik

    Mainz, 55131

  • Universitätsmedizin Mannheim, Urologische Klinik

    Mannheim, 68167

  • Klinikum rechts der Isar der TU München, Urologische Klinik und Poliklinik

    München, 81675

  • Klinik für Urologie, Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Italy1 site

  • Fondazione scientifica Istituto San Raffaele

    Milan, 20132

Other trials in Italy

About this study

The purpose of this study is to determine the efficacy and safety of a new vaccine in hormone refractory prostate cancer

Read the detailed description

Immunotherapy of prostate cancer is a promising approach for the treatment of advanced or recurrent forms of prostate cancer. Recently, immunotherapy of prostate cancer has been facilitated by the identification of a number of prostate specific antigens that are expressed in healthy and tumor prostate tissues. For prostatectomized patients, such antigens offer ideal targets for immunotherapy as they are only present in tumor but not in healthy tissue. The use of prostate specific antigens in a cancer vaccine is one attractive option for cancer immunotherapy.

Being tested
CV9103
Keywords
Hormonal refractory prostate cancer, RNA vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CV9103Biological

    Over a period of 23 weeks 5 vaccinations with CV9103 will be administered.

Study groups in NCT00831467
Study groupRoleWhat they receive
CV9103ExperimentalCV9103 is applied intradermally into the thigh and upper arm of either side of the body at week 1, week 3, week 7, week 15, week 23
Receives: Biological: CV9103

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of the recommended dose for exploration in the phase II part

    Measured: 6-9 months

  2. Assessment of Safety of trial regimen

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2009
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00831467
Sponsor's protocol ID
CV-9103-001
Status last verified
Mar 2018
First submitted
27 Jan 2009
Last updated
20 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Fotin-Mleczek M, Duchardt KM, Lorenz C, Pfeiffer R, Ojkic-Zrna S, Probst J, Kallen KJ. Messenger RNA-based vaccines with dual activity induce balanced TLR-7 dependent adaptive immune responses and provide antitumor activity. J Immunother. 2011 Jan;34(1):1-15. doi: 10.1097/CJI.0b013e3181f7dbe8.

    PubMed 21150709

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CV9103 in people with Hormonal Refractory Prostate Cancer, run by CureVac at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the recommended dose for exploration in the phase II part (time frame: 6-9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00831467, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.

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