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临床试验/EUCTR2011-006314-14-CZ
EUCTR2011-006314-14-CZ进行中（未招募）1 期

A Randomised, Double-blind, Placebo-controlled, Phase I/II Trial of RNActive®-derived Cancer Vaccine (CV9104) in Asymptomatic or Minimally Symptomatic Patients with Metastatic Castrate-refractory Prostate Cancer

CureVac AG0 个研究点目标入组 200 人开始时间: 2012年11月7日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
200
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
Male

入选标准

  • •1. Male, age = 18 years
  • •2. Histologically confirmed castrate-refractory metastatic adenocarcinoma of the prostate with progressive disease
  • •- after surgical castration; or during androgen suppression therapy, including a gonadoptropin-releasing hormone (GNRH) agonist or antagonist and
  • •- after at least 1 second-line anti-hormonal manipulation (e.g. antiandrogen; including combined androgen blockade followed by
  • •antiandrogen withdrawal)
  • •- a serum testosterone level of < 50 ng/dL or < 1.7 nmol/L.
  • •Progression will be confirmed either
  • •- radiologically (nodal or other soft tissue progression, appearance of 2 or more new lesions on bone scan - to be confirmed by other imaging if
  • •flare or trauma is suspected); or
  • •- by 2 consecutive rises of PSA, measured at least 1 week apart, resulting at least in a 50% increase over the nadir and PSA > 2 ng/mL.
  • •The last of these PSA values must have been measured within 2 months prior to start of screening and
  • •- In patients having received initial combined androgen blockade or have shown a decline in PSA for =3 months after administration of an
  • •antiandrogen an antiandrogen withdrawal response must have been excluded after discontinuation of antiandrogen therapy (e.g. bicalutamide, flutamide or nilutamide) for at least 6 weeks prior to randomisation. Patients with a confirmed progression (PCWG2) after an antiandrogen withdrawal response are eligible. All patients must have discontinued antiandrogen treatment prior to randomization
  • •3. Metastatic disease confirmed by imaging (bone scan, computedtomography [CT] or magnetic-resonance imaging [MRI]); ambiguous bone scan results should be confirmed by a second method.
  • •4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0 to 1.
  • •5. Patients should be unlikely to need subsequent systemic therapy within the next 4 weeks (safety lead-in) or the next 3 months (randomised portion), in the opinion of the investigator.
  • •6. Adequate organ function:
  • •- Bone marrow function: haemoglobin =100 g/L; white blood cell count =3.0 × 1.000.000.000/L; lymphocyte count =0.8 × 1.000.000.000/L; absolute neutrophil count =1.5 × 1.000.000.000/L; platelet count =100 × 1.000.000.000/L.
  • •- Hepatic: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 × upper limit of normal; bilirubin =1.5 × upper limit of normal.
  • •- Renal: creatinine =2 mg/dL and creatinine clearance =45 mL/min/1.73m2.
  • •7. Men of child producing potential must agree that together with their female partners they will use a highly effective method of contraception
  • •as defined in ICH (M3) resulting in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Those methods include
  • •implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomy. The contraception
  • •should be applied until 1 month after the last vaccination.
  • •8. Patients requiring bisphosphonates or denosumab at the time of registration into the trial are eligible as long as therapy is initiated at
  • •least 28 days prior to first study treatment administration and it must be continued during the study unless contraindications arise.
  • •9. Patient has provided written informed consent.
  • •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 50
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 150

排除标准

  • •1. Previous immunotherapy for PCA (e.g. sipuleucel-T [Provenge®], experimental cancer vaccines or ipilimumab [Yervoy®]).
  • •2. Estimated life expectancy of < 6 months due to PCA or concomitant disease.
  • •3. Treatment with any investigational anticancer agents within 4 weeks or 5 half-lives according to what gives the longer range prior to first
  • •dose of study drug.
  • •4. Acute pathologic fracture or spinal cord compression at screening.
  • •5. Systemic immunosuppressive agents including systemic steroids or immunomodulating agents including herbal remedies (e.g. mistletoe
  • •extract) for the previous 28 days prior to the start of treatment or need for such immunosuppressive/-modulating treatment, except
  • •glucocorticoid replacement therapy for adrenal insufficiency. For other conditions where steroid therapy is allowed, see section on prior and
  • •concomitant therapy (Section 6.3).
  • •6. Active skin disease (atopic eczema, psoriasis) in the areas for vaccine injection (upper arms or thighs) preventing the administration of i.d.
  • •injections into areas of healthy skin.
  • •7. Concurrent major surgery or planned surgery.
  • •8. Prior splenectomy or prior allogeneic bone marrow transplant.
  • •9. History of or current autoimmune disorders such as sarcoidosis, lupus erythematosus, rheumatoid arthritis, glomerulonephritis systemic
  • •vasculitis, autoimmune hepatitis, Sjögren syndrome, scleroderma, polymyalgia rheumatica, arteriitis temporalis, calcinosis, Raynauds
  • •disease, esophageal dysmotility, sclerodactyly and telangiectasia (CREST) syndrome (limited cutaneous scleroderma), dermatomyositis,
  • •Morbus Crohn and colitis ulcerosa except autoimmune thyroiditis with only thyroid hormone replacement or vitiligo or Diabetes Mellitus type 1.
  • •10. Primary or secondary immune deficiency.
  • •11. Allergies to any components of the study drug including allergy to protamine sulfate (e.g. allergy to protamine containing
  • •insulins) or fish allergy.
  • •12. Allergies to penicillins or other ß-lactam antibiotics
  • •13. Active infections requiring anti-infectious therapy at the time of randomization.
  • •14. Seropositive for human immunodeficiency virus, hepatitis B virus (except after hepatitis B vaccination) or hepatitis C virus infection.
  • •15. Uncontrolled urinary retention or hydronephrosis (to be confirmed by ultrasound, bladder scan or other adequate imaging method).
  • •Patients with urinary retention can be enrolled after adequate treatment, see section 6.3.
  • •16. Uncontrolled medical condition considered as high risk for the treatment with an investigational drug (e.g. unstable Diabetes Mellitus,
  • •vena-cava-syndrome, uncontrolled pleural effusion, acute pulmonary embolism).
  • •17. Known brain metastases or leptomeningeal involvement.
  • •18. Symptomatic congestive heart failure (New York Heart Association 3 or 4), unstable angina pectoris or myocardial infarction, significant
  • •cardiac arrhythmia, history of stroke or transient ischemic attack, all within 6 months prior to enrolment or severe hypertension according to
  • •WHO criteria or uncontrolled hypertension at the time of enrolment(systolic blood pressure =180 mm Hg).
  • •19. History of seizures, encephalitis or multiple sclerosis.
  • •20. Active drug abuse or chronic alcoholism.
  • •21. Inability to provide informed consent due to mental impairment.
  • •The following are additional exclusion criteria only for patients participating in the randomised part of the trial:
  • •22. Previous chemotherapy for metastatic PCA.
  • •23. Previous anti-hormonal treatme

研究者

发起方
CureVac AG

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