Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments cv9104, placebo
Phase phase 1/phase 2
Sponsor CureVac AG
Start date August 2012
End date September 2016
Trial size 197 participants
Trial identifier NCT01817738, CV-9104-004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
CV9104 intradermal injection
cv9104
Intradermal injection of CV9104
(Placebo Comparator)
Placebo intradermal injection
placebo
Intradermal injection of placebo

Primary Outcomes

Measure
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
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male participants at least 18 years old.

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).

Additional Information

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
Principal investigator Arnulf Stenzl, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by CureVac AG.