EUCTR2019-000951-14-SE进行中（未招募）1 期
A Phase 2, Double-Blind, Placebo Controlled Study of RV001V in Men with Biochemical Failure following Curatively Intended Therapy for Localized Prostate Cancer - BRaVac
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- RhoVac ApS
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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 <12 months
- •Conversely, if the patient was treated with definitive RT and not prior RP, all the following will apply:
- •a. PSA >nadira + 2 ng/mL,
- •b. PSADTa >3 months and <12 months
- •6. Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •7. Laboratory values obtained =30 days prior to first vaccination
- •a. Hemoglobin =5.6 mmol/L (0.72 g/L)
- •b. Absolute granulocyte count =1.5 x 109 /L.
- •c. Platelets =100 x 109 /L.
- •d. Total bilirubin =1.5 x upper limit of normal (ULN).
- •e. Creatinine =1.5 x ULN.
- •f. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) =2.5 x ULN.
- •aNote: Instructions for PSADT calculation: All PSA values used in the calculation should be =0.20 ng/ml and follow a rising trend. PSA values
- •need not be consecutively rising and all values obtained over a maximum period of 12 months should be included in the calculation. The maximum
- •period of the past 12 months is recommended to reflect the patient's current disease activity, since in some men PSADT may change over
- •time. Minimum requirements for the calculation are 3 PSA values obtained over 3 months with a minimum of 4 weeks between
- •measurements. For PSADT calculation after prior RT: A nadir subtraction approach will be applied, wherein the nadir PSA concentration, defined
- •as the lowest PSA value observed following RT, is subtracted from the post-RT PSA concentrations before calculating PSADT[1].
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •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 <50 ng/dL at screening.
- •5. PSA >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
研究者
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