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JOURNAL ONKOLOGIE – STUDIE
BRaVac

Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer

Rekrutierend

NCT-Nummer:
NCT04114825

Studienbeginn:
November 2019

Letztes Update:
02.03.2021

Wirkstoff:
RV001V

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
RhoVac APS

Collaborator:
-

Studienleiter

Klaus Brasso, MD
Principal Investigator
Rigshospitalet, Denmark

Kontakt

Studienlocations
(3 von 32)

Alle anzeigen

Studien-Informationen

Brief Summary:

This Phase II trial will enroll approximately 180 adult male patients with an earlier

histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3

years of radical prostatectomy (RP) or definitive RT and no distant metastasis or

locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a

peptide cancer vaccine (RV001V).

Ein-/Ausschlusskriterien

Main Inclusion Criteria:

- Biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or

definitive RT and no distant metastasis by standard CT imaging and bone scintigraphy,

or locoregional recurrence (including lymph nodes) assessed by CT or multi-parametric

magnetic resonance imaging (MRI) and confirmed with negative biopsy in case of prior

RT.

- In case of BCR after RP all the following criteria should apply: a. PSA ≥0.2 ng/mL, b.

PSA Doubling Time (PSADT) >3 months and <12 months

- In case of BCR after RT all the following criteria should apply: a. PSA >nadir + 2

ng/mL, b. PSADT >3 months and <12 months

- ECOG performance status ≤2.

- Laboratory values obtained ≤30 days prior to first vaccination: Hemoglobin ≥5.6

mmol/L; Absolute granulocyte count ≥1.5 x 109 /L, Platelets ≥100 x 109 /L., Total

bilirubin ≤1.5 x upper limit of normal (ULN).

- Creatinine ≤1.5 x ULN.

- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline

phosphatase (ALP) ≤2.5 x ULN.

Main Exclusion Criteria:

- Patients who are receiving androgen-deprivation therapy or considered a candidate for

immediate anti-androgen deprivation therapy (ADT) as judged by the investigator.

- Patients who have received prior ADT are not eligible with the exception of those that

received ADT ≤36 months in duration and ≥9 months before randomization and

administered only in the neoadjuvant/adjuvant setting.

- Patient is planned for salvage therapy with RT or radical prostatectomy.

- Castrate level of serum testosterone <50 ng/dL at screening.

- PSA >10 ng/mL.

Studien-Rationale

Primary outcome:

1. Time to PSA progression (Time Frame - Up to 3 years):
Time to PSA progression is defined as the time from randomization to doubling of PSA from the baseline value. The time to doubling will be estimated from a log-linear regression of PSA values.



Secondary outcome:

1. Safety by frequency and severity of adverse events (AEs) (Time Frame - Up to 16 months):
The numbers and proportions of patients with any treatment-emergent adverse event (TEAE), and any serious TEAE will be summarized

2. Time to initiation of a subsequent antineoplastic therapy (Time Frame - Up to 3 years)

3. Proportion of patients showing a PSA response from baseline (Time Frame - Up to 3 years)

4. Disease-free survival (DFS) (Time Frame - Up to 3 years):
time from randomization to documented clinical recurrence (distant or local), or death from any cause, censoring at date of last follow-up (FU)

Studien-Arme

  • Experimental: RV001V
    Total of 12 SC vaccinations with RV001V. The first 6 vaccinations (priming period) will be given every 2 weeks, and then the following 5 vaccinations (7 through 11) will be administered with 4 weeks between each vaccination (Maintenance period), and the last vaccination (12th) will be administered 6 months following the 11th vaccination (boosting injection).
  • Placebo Comparator: Placebo
    Total of 12 SC vaccinations with placebo. The first 6 vaccinations (priming period) will be given every 2 weeks, and then the following 5 vaccinations (7 through 11) will be administered with 4 weeks between each vaccination (Maintenance period), and the last vaccination (12th) will be administered 6 months following the 11th vaccination (boosting injection).

Geprüfte Regime

  • RV001V:
    RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).
  • Placebo:
    Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo

Quelle: ClinicalTrials.gov


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