ACTRN12620001286932招募中2 期
eoadjuvant Study of the effect of Intratumoural and Intravenous Pexastimogene Devacirepvec (Pexa-Vec) on CD8-based anti-tumour response in Prostate Cancer Prior to Radical Prostatectomy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1.Patient has provided written informed consent
- •2.Patients with histologically confirmed prostate adenocarcinoma
- •3.Age greater than or equal to 18 years
- •4.Suitable for radical prostatectomy in the opinion of the treating surgeon, following results of all screening investigations, including PSMA PET/CT scan
- •5.Disease detectable on MRI
- •6.Patient has adequate organ function within 7 days prior to registration as defined as:
- •White blood cell count (WCC) greater than or equal to 2 x 109/L
- •Absolute neutrophil count (ANC) greater than or equal to 1 x 109/L
- •Haemoglobin greater than or equal to 90 g/L
- •Platelet count greater than or equal to 100 x 109/L
- •Activated partial thromboplastin time (aPTT) less than or equal to 1.5 ULN
- •International Normalized Ratio (INR) less than or equal to 1.5 ULN
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN unless liver metastases are present, in which case it must be less than or equal to 5 x ULN
- •Serum sodium 130-150mmol/L
- •Serum potassium 3.0-5.5mmol/L
- •Serum Corrected Calcium 2.0-2.9 mmol/L
- •Serum Creatinine less than or equal to 1.5 ULN or estimated glomerular filtration rate greater than 30mL/min/1.73m2
- •Oxygen saturation (SaO2) by pulse oximetry greater than 90% at rest
- •7.For patients who are sexually active with partners of childbearing potential: willing to use double barrier contraception method for at least 6 weeks after each treatment of Pexa-Vec
- •8.Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations during both the treatment and follow-up phases
排除标准
- •1.Prior anti-cancer therapy for prostate cancer
- •2.High volume metastatic disease on imaging including PSMA PET/CT as defined by
- •one or more of the following criteria:
- •a.The presence of visceral metastases
- •b.greater than or equal to 4 bone lesions, including greater than or equal to 1 beyond the vertebral bodies and pelvis
- •3.Low-risk prostate cancer as defined by all of the following criteria
- •a.PSA < 20ng/ml
- •b.Gleason score 3+4=7 or equal to or less than 6
- •c.Clinor equal toical stage < T2c
- •4.Known immunodeficiency due to underlying illness (e.g., human immunodeficiency
- •virus [HIV] / acquired immune deficiency syndrome [AIDS]) and/or long-term
- •immune-suppressive medication including high-dose corticosteroids (defined as >10
- •mg/day prednisone or equivalent)
- •5.Known myeloproliferative disorders requiring systemic therapy
- •6.History of severe inflammatory or exfoliative skin condition (e.g. eczema or ectopic
- •dermatitis) requiring systemic therapy
- •7.Tumour in location that would potentially result in significant clinical adverse effects if post-treatment tumour swelling were to occur
- •8.Tumour invading a major vascular structure or other key anatomical structure
- •9.Severe or unstable cardiovascular disease, including but not limited to significant
- •coronary artery disease (e.g., myocardial infarction or other coronary artery disease
- •requiring angioplasty or stenting) or congestive heart failure within the preceding 12
- •10.Inability to suspend treatment with anti-hypertensive medication (including but not
- •limited to: diuretics, beta-blockers, angiotensin converting enzyme [ACE] inhibitors,
- •aldosterone antagonists, etc.) for 48 hours prior to and 48 hours after all Pexa-Vec
- •11.Use of anti-viral medications
- •12.Use of anti-platelet, or anti-coagulation medication that cannot be safely suspended
- •prior to IT injections
- •13.Medical conditions that place the patient at risk should tachycardia, hypotension or
- •volume loading occur during or following treatment with Pexa-Vec
- •14.Experienced a severe systemic reaction or side-effect as a result of a previous
- •smallpox vaccination
- •15.Other medical condition or laboratory abnormality or active infection that in the
- •judgment of the Investigator may increase the risk associated with study participation
- •or may interfere with interpretation of study results and/or otherwise make the patient
- •inappropriate for entry into this study
- •16.Prior malignancy except for cancer from which the patient has been disease-free for 3
- •years, or the following: adequately treated basal or squamous cell skin cancer, in situ
- •carcinoma (including cervical, breast and superficial bladder cancer)
- •17.Prior or planned organ transplant
- •18.Use of interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be
- •discontinued within 14 days prior to any Pexa-Vec dose
- •19.Known active Hepatitis B or Hepatitis C
- •20.Patients must not receive live vaccines, other than Pexa-Vec, within 30 days of
- •planned start of Pexa-Vec, during the study, and for a minimum of 15 weeks after the
- •last dose of Pexa-Vec
- •21.Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural
- •22.Inability to avoid direct physical contact
研究者
相似试验
进行中（未招募）
1 期
Phase 1b/2 Study of V937 Injected into Tumors in Combination with Intravenous (IV) PembrolizumabAdvanced/metastatic solid tumorsMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2020-001908-42-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc185
进行中（未招募）
1 期
Phase 1b/2 Study of V937 Injected into Tumors in Combination with Intravenous (IV) PembrolizumabEUCTR2020-001908-42-PTMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc185
进行中（未招募）
1 期
Phase 1b/2 Study of V937 Injected into Tumors in Combination with Intravenous (IV) PembrolizumabEUCTR2020-001908-42-ITMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.185
已完成
1 期
Phase 1b/2 Study of ITu V937 in Combination with PembrolizumabJPRN-jRCT2033200191ohata Nijiro185
进行中（未招募）
1 期
Phase 1b/2 Study of V937 Injected into Tumors in Combination with Intravenous (IV) PembrolizumabAdvanced/metastatic solid tumorsMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2020-001908-42-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc185