ACTRN12621000156886尚未招募1 期
A pilot study of Perindopril in combination with first line Ipilimumab and Nivolumab for patients with unresectable or metastatic melanoma- ACE-IT 001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Male or Female subjects aged 18 years or over.
- •2.Written informed consent.
- •3.Willingness to comply with trial requirements
- •4.Eligible to receive Nivolumab and Ipilimumab checkpoint inhibitor as per local standard of care for the treatment of metastatic or unresectable melanoma who are treatment naïve.
- •5.Must not have received any prior systemic cancer therapies including but not limited to prior PD-1/PD-L1 or CTLA-4 checkpoint inhibitors. Patients who have received PD-1/PD-L1 or CTLA-4 inhibitors in the adjuvant or neo-adjuvant setting are eligible if it has been >6 months since the last dose of PD-1/PD-L1 therapy.
- •6.Adequate haematological function defined by:
- •oAbsolute neutrophil count equal to or greater that 1.0 x 109/L.
- •oPlatelet count equal to or greater than 80 x 109/L.
- •oHaemoglobin equal to or greater than 9g/dL – without prior transfusion within last 28 days.
- •7.Adequate hepatic function defined by:
- •o Total bilirubin level equal to or greater than 1.5 x ULN.
- •oAST and ALT levels equal to or greater than 2.5 x ULN unless liver metastases present then equal to or greater than 5 X ULN.
- •8.Adequate renal function defined by:
- •oEstimated creatinine clearance of greater than 40mL/min according to the Cockcroft-Gault formula.
- •9.Measurable disease as per RECIST 1.1 guidelines. Disease status before first treatment will be documented by contrast CT of the Chest, Abdomen, Pelvis and any known sites of disease. An MRI/CT Brain may be performed if clinically indicated at the discretion of the investigator. PET scans may be performed in addition to CT scans as per standard of care, but will not be used to assess response rates during the course of the study.
- •10.Presence of brain metastasis is acceptable if stability is demonstrated for at least 4 weeks prior to initiation of therapy.
- •11.ECOG performance status 0-2.
- •12.Autoimmune conditions must be stable for > 12 months prior to study entry and not require systemic immunosuppressive treatment. Topical steroid treatment for psoriasis will be allowed.
- •13.Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to first dose of study treatment.
- •14.Women must not be breastfeeding.
- •15.Women of childbearing potential (WOCBP) must agree to use effective contraception from the time informed consent is signed, the duration of the study and for 30 days after ceasing trial participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately.
- •16.Males who are sexually active with WOCBP must agree to use effective contraception for the duration of the study and for 30 days after ceasing trial participation.
排除标准
- •1.Any known condition that in the opinion of the investigator will interfere with the study results or may inflict harm on the participant.
- •2.Known hypersensitivity to any of the prescribed treatments.
- •3.Any contraindication to perindopril that is deemed significant by the treating investigator.
- •4.Current use of anti-hypertensive, anti-coagulation or diuretic treatments.
- •5.Current regular use of NSAID’s within 30 days prior to treatment.
- •6.Vaccination within 28 days of the first treatment dose.
- •7.Prior Radiation treatment within 2 weeks of planned first dose of PD-1/PD-L1 therapy.
研究者
相似试验
进行中（未招募）
不适用
Efficacy of perindopril/indapamide combination on coronary Pet Scan parameters. A 6 month, open non controlled stydy in hypertensive patientsEssential arterial hypertensionMedDRA version: 6.1Level: PTClassification code 10015488EUCTR2004-003955-37-ITINSTITUT DE RECHERCHES INTERNATIONALES SERVIER
招募中
不适用
The effect of concomitant administration of perdipine on vital signs when dexmedetomidine is administered for sedation after spinal anesthesiaKCT0002864Kyung Hee University Hospital60
已完成
不适用
The prospective study of effect of ifenprodil on relapse prevention in patients with substance dependenceAlcohol dependenceJPRN-UMIN000006347Tokyo Metropolitan Institute of Medical Science100
进行中（未招募）
1 期
Fixed-Dose Combination of Perindopril/Amlodipine (Amlessa®) and Fixed-Dose Combination of Perindopril/Indapamide /Amlodipine (Co-Amlessa®) - Contribution to Management in newly diagnosed and uncontrolled hypertensive patients (PRECIOUS study)ewly diagnosed and uncontrolled patients with essential arterial hypertension.MedDRA version: 20.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersEUCTR2017-001596-23-HRKrka, d.d., Novo mesto471
进行中（未招募）
1 期
Fixed-Dose Combination of Perindopril/Amlodipine (Amlessa®) and Fixed-Dose Combination of Perindopril/Indapamide /Amlodipine (Co-Amlessa®) - Contribution to Management in newly diagnosed and uncontrolled hypertensive patients (PRECIOUS study)ewly diagnosed and uncontrolled patients with essential arterial hypertension.MedDRA version: 20.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersEUCTR2017-001596-23-PLKrka, d.d., Novo mesto471