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
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: CV9104 Biological: Placebo||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||197 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||January 2017|
Active Comparator: CV9104
CV9104 intradermal injection
Intradermal injection of CV9104
Placebo Comparator: Placebo
Placebo intradermal injection
Intradermal injection of placebo
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Male, age ≥18 years
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.
- Metastatic disease confirmed by imaging
- ECOG performance status 0 or 1
Key Exclusion Criteria:
- Previous immunotherapy for PCA (e.g. sipuleucel-T [Provenge®], experimental cancer vaccines or ipilimumab [Yervoy®]).
- Treatment with any investigational anticancer agents within 4 weeks prior to first dose of study drug
- Systemic treatment with immunosuppressive agents
- 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.
- History of or current autoimmune disorders
- Primary or secondary immune deficiency.
- Seropositive for human immunodeficiency virus, hepatitis B virus (except after hepatitis B vaccination) or hepatitis C virus infection.
- 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)´
- Previous chemotherapy for metastatic PCA.
- Previous anti-hormonal treatment with abiraterone or any other investigational anti-hormonal treatment.
- Cancer-related pain requiring opioid narcotics within 28 days before enrolment or an average pain score of > 3 on a visual analogue scale.
- Presence of visceral metastases.
- History of other malignancies other than PCA over the last 5 years (except basal cell carcinoma of the skin).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817738
|Principal Investigator:||Arnulf Stenzl, Prof. Dr.||University Hospital of Tübingen; Dept. of Urology|
|Other Study ID Numbers:||
|First Posted:||March 25, 2013 Key Record Dates|
|Last Update Posted:||February 17, 2017|
|Last Verified:||April 2016|
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases