Trial record 1 of 1 for:
BRaVac
Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer (BRaVac)
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| ClinicalTrials.gov Identifier: NCT04114825 |
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Recruitment Status :
Active, not recruiting
First Posted : October 3, 2019
Last Update Posted : September 28, 2021
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Sponsor:
RhoVac APS
Information provided by (Responsible Party):
RhoVac APS
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer Recurrent | Biological: RV001V Other: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Double-Blind, Placebo Controlled Study of RV001V in Men With Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer (BRaVac) |
| Actual Study Start Date : | November 19, 2019 |
| Estimated Primary Completion Date : | April 2022 |
| Estimated Study Completion Date : | November 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
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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).
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Biological: RV001V
RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V). |
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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).
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Other: Placebo
Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo |
Primary Outcome Measures :
- 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 Measures :
- 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
- Time to initiation of a subsequent antineoplastic therapy [ Time Frame: Up to 3 years ]
- Proportion of patients showing a PSA response from baseline [ Time Frame: Up to 3 years ]
- 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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): NCT04114825
Locations
Show 36 study locations
Sponsors and Collaborators
RhoVac APS
Investigators
| Principal Investigator: | Klaus Brasso, MD | Rigshospitalet, Denmark |
| Responsible Party: | RhoVac APS |
| ClinicalTrials.gov Identifier: | NCT04114825 |
| Other Study ID Numbers: |
RhoVac-002 |
| First Posted: | October 3, 2019 Key Record Dates |
| Last Update Posted: | September 28, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by RhoVac APS:
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Biochemical relapse |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |