EUCTR2019-000951-14-DE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.
- •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
相似试验
进行中（未招募）
1 期
A study to assess effectiveness and safety of a drug RV001V in Men with Biochemical Failure following Curatively Intended Therapy for Localized Prostate CancerMedDRA version: 20.0Level: LLTClassification code 10007113Term: Cancer of prostateSystem Organ Class: 100000004864Prostate cancerEUCTR2019-000951-14-GBRhoVac ApS180
进行中（未招募）
1 期
A study to assess effectiveness and safety of a drug RV001V in Men with Biochemical Failure following Curatively Intended Therapy for Localized Prostate CancerMedDRA version: 20.0Level: LLTClassification code 10007113Term: Cancer of prostateSystem Organ Class: 100000004864Prostate cancerEUCTR2019-000951-14-SERhoVac ApS180
进行中（未招募）
1 期
A study to assess effectiveness and safety of a drug RV001V in Men with Biochemical Failure following Curatively Intended Therapy for Localized Prostate CancerProstate cancerEUCTR2019-000951-14-FIRhoVac ApS180
进行中（未招募）
1 期
A study to assess effectiveness and safety of a drug RV001V in Men with Biochemical Failure following Curatively Intended Therapy for Localized Prostate CancerProstate cancerEUCTR2019-000951-14-DKRhoVac ApS180
进行中（未招募）
不适用
A study in patients with chondrosarcoma comparing IPI-926 to placeboEUCTR2010-024518-74-ESInfinity Pharmaceuticals, Inc169