Prostate cancer MedDRA version: 20.0 Level: LLT Classification code 10007113 Term: Cancer of prostate System Organ Class: 100000004864
Conditions
Interventions
Product Name: RV001 Vaccine 0.1 mg/mL
Product Code: RV001V
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: RV001 (INN not yet assigned)
Current Sponsor code: RV001
Concentration unit:
Sponsors
RhoVac ApS
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men aged 18 and above with an earlier histologic diagnosis of prostatic adenocarcinoma. 2. Able to understand the study procedures and willing to provide IC. 3. Able and willing to comply with study requirements and complete all visits. 4. Biochemical recurrence (BCR) in compliance with the following 3 conditions: -after having finished last definitive treatment (including those who have received RP/RT followed by any modality of salvage therapy), -no distant metastasis by standard CT imaging with bone scintigraphy or a normal PET-CT and -no locoregional recurrence (including lymph nodes). Locoregional recurrence will be assessed by multi-parametric magnetic resonance imaging (MRI) in all patients treated with curative RT and should be confirmed with image guided prostatic gland biopsy in case of suspicious lesions. Any prostatic biopsy performed should be negative. 5. Prior definitive treatment with RP or RT. In case the patient was subjected to a RP, all the following will apply: a. PSA =0.2 ng/mL, b. PSA Doubling Time (PSADT)a >3 months and nadira + 2 ng/mL, b. PSADTa >3 months and =65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. Patients who are receiving androgen-deprivation therapy (ADT) or considered a candidate for immediate ADT or are candidate to any local therapy according to applicable clinical guidelines or judged by the investigator. 2. 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. 3. Patient is planned for salvage therapy. 4. Castrate level of serum testosterone 10 ng/mL. 6. Small-cell, signet cell and neuroendocrine variants of adenocarcinomas. 7. An active malignancy likely to interfere with protocol treatment or FU. 8. Patients who have undergone major surgery or have had major bleeding within the last month prior to the first vaccination. 9. Prior treatment with any therapeutic cancer vaccine(s). 10. Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 11. History of alcohol or substance abuse within the last 5 years. 12. Patients receiving any investigational drug(s) or treatment within 30 days prior to inclusion in this trial. 13. History of significant autoimmune disease such as Inflammatory Bowel Disease, Systemic Lupus Erythematosus, Ankylosing Spondylitis, Scleroderma, Multiple Sclerosis. 14. Severe medical conditions, such as but not limited to severe asthma/chronic obstructive pulmonary disease (COPD), New York Heart Association (NYHA) grading 3 or above, poorly regulated insulin dependent diabetes, any significant organ damage as judged by the Investigator. 15. Other medications, conditions or laboratory results that in the Investigator's opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results. 16. History of known allergy/hypersensitivity to any component of the study drug (such as Montanide ISA 51), or intolerance to SC injection. 17. Patients with a prior solid organ / stem cell transplantation 18. Patients with known acquired immunodeficiency disorder (AIDS) or any inherited immunodeficiency disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate whether a vaccination regimen with multiple subcutaneous (SC) administrations of RV001 Vaccine 0.1 mg/mL (RV001V) can reduce prostate-specific antigen (PSA) progression compared to the control group.;Secondary Objective: The secondary objectives are: - To evaluate the safety and tolerability of RV001 Vaccine 0.1 mg/mL (RV001V) following SC administrations to patients who have a biochemical relapse following definitive local therapy prostatectomy or radiation therapy due to prostate cancer. - To evaluate whether the vaccination regimen can delay the time to subsequent antineoplastic therapy initiation and substantiate other clinical benefits compared to the control group.;Primary end point(s): The primary endpoint of the study is the time to PSA progression is defined as the time from randomization to doubling of PSA from the baseline value, clinical recurrence or death from any cause, whichever occurs first. The time to doubling will be estimated from a log-linear regression of PSA values as dependent variable and considering time as the independent variable in the model. Estimated time to doubling will be calculating as 1/ß where ß is the slope of the log- linear regression. ;Timepoint(s) of evaluation of this end point: The end-of-treatment is within 30 days after the final dose of study treatment. Follow-up visits will begin 12 weeks after end-of-treatment visit, and then every 12 weeks until the patient reaches primary endpoint, or until primary analysis. When the patient reaches a primary endpoint he will move into extended follow up for safety monitoring until the study is terminated 36 months after first patient’s first injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The safety will be evaluated with frequency and severity of adverse events (AEs). The numbers and proportions of patients with any treatment-emergent adverse event (TEAE), and any serious TEAE will be summarized. Immune-related AEs (irAEs) will be reported, evaluated and managed following the procedure detailed in Section 9. Safety monitoring and review. •Time to initiation of a subsequent antineoplastic therapy. •Proportion of patients initiating a subsequent antineoplastic therapy. •PSA doubling time (PSADT) based on uncensored data. •Proportion of patients showing a PSA response from baseline (50% and 30%, best and at 26 weeks): a.50% PSA response is defined as a decrease in PSA level of at least 50% (compared to baseline PSA) at 26 weeks (Visit 12) after baseline. b.30% PSA response is defined as a decrease in PSA level of at least 30% (compared to baseline PSA) at 26 weeks (Visit 12) after baseline. c.Best PSA response is defined as the proportion of patients who have at least a 30% or 50% decrease in PSA level (compared to baseline PSA) at any time point post-randomization. •Disease-free survival (DFS) is defined as time from randomization to documented clinical recurrence (distant or local), or death from any cause, censoring at date of last follow-up (FU). ;Timepoint(s) of evaluation of this end point: The end-of-treatment is within 30 days after the final dose of study treatment. Follow-up visits will begin 12 weeks after end-of-treatment visit, and then every 12 weeks until the patient reaches primary endpoint, or until primary analysis. When the patient reaches a primary endpoint he will move into extended follow up for safety monitoring until the study is terminated 36 months after first patient’s first injection. | — |
Countries
Finland, Germany, Sweden, United Kingdom
Contacts
Public ContactMalene Weis
RhoVac ApS
Outcome results
None listed