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

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ClinicalTrials.gov Identifier: NCT01817738
Recruitment Status : Terminated (Follow up period after primary analysis was prematurely stopped because more mature data will not impact the study outcome)
First Posted : March 25, 2013
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
CureVac AG

Tracking Information
First Submitted Date  ICMJE February 8, 2013
First Posted Date  ICMJE March 25, 2013
Last Update Posted Date February 17, 2017
Study Start Date  ICMJE August 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2013)
  • 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 [ 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 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Biological: CV9104
    Intradermal injection of CV9104
  • Biological: Placebo
    Intradermal injection of placebo
Study Arms  ICMJE
  • Active Comparator: CV9104
    CV9104 intradermal injection
    Intervention: Biological: CV9104
  • Placebo Comparator: Placebo
    Placebo intradermal injection
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 19, 2013)
197
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2013)
200
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   France,   Germany,   Poland,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01817738
Other Study ID Numbers  ICMJE CV-9104-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CureVac AG
Study Sponsor  ICMJE CureVac AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnulf Stenzl, Prof. Dr. University Hospital of Tübingen; Dept. of Urology
PRS Account CureVac AG
Verification Date April 2016

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