Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CureVac GmbH
ClinicalTrials.gov Identifier:
NCT01817738
First received: February 8, 2013
Last updated: December 19, 2013
Last verified: December 2013

February 8, 2013
December 19, 2013
August 2012
September 2016   (final data collection date for primary 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 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01817738 on ClinicalTrials.gov Archive Site
  • Progression free survival from date of randomisation [ Time Frame: Every 3 months for up to 2 years ] [ Designated as safety issue: No ]
  • Progression free survival from start of first subsequent systemic therapy [ Time Frame: Every 6 months until 2 years ] [ Designated as safety issue: No ]
  • Percent change to maximal and to minimal PSA from baseline and before start of first subsequent systemic cancer therapy [ Time Frame: Every 3 months up to 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Absolute change from baseline FACT P score and subscores [ Time Frame: Assessments at baseline, weeks 5,9,18,24 and every 3 months for up to 2 years ] [ Designated as safety issue: No ]
  • Absolute change 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer
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 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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • Biological: CV9104
    Intradermal injection of CV9104
  • Biological: Placebo
    Intradermal injection of placebo
  • Active Comparator: CV9104
    CV9104 intradermal injection
    Intervention: Biological: CV9104
  • Placebo Comparator: Placebo
    Placebo intradermal injection
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
197
December 2016
September 2016   (final data collection date for primary outcome measure)

Key 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).
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Sweden,   Poland,   Switzerland,   United Kingdom,   Spain,   Czech Republic,   France
 
NCT01817738
CV-9104-004
Yes
CureVac GmbH
CureVac GmbH
Not Provided
Principal Investigator: Arnulf Stenzl, Prof. Dr. Universityhospital of Tübingen; Dept. of Urology
CureVac GmbH
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP