2023-508156-20-00招募中3 期
A Phase III Randomized Controlled Multicentre Trial of Percutaneous Hepatic Perfusion in Combination with Ipilimumab and Nivolumab Compared to Ipilimumab and Nivolumab Only in Patients with Uveal Melanoma Liver Metastases – the SCANDIUM III trial
Vaestra Goetalandsregionen6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The primary objective is to evaluate progression-free survival in patients with uveal melanoma liver metastases randomized to either percutaneous hepatic perfusion (PHP) in combination with ipilimumab and nivolumab or ipilimumab and nivolumab only.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥18 years.
- •Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- •Signed informed consent.
- •ECOG performance status of 0 or
- •Histologically or cytologically confirmed liver metastasis of uveal melanoma.
- •Measurable disease by computed tomography (CT) per RECIST 1.1 criteria with at least one target lesion identified in the liver.
- •No previous treatment for uveal melanoma metastases, except patients that have confirmed progression on tebentafusp, or after surgical resection or ablative treatments (e.g., radiofrequency ablation or stereotactic body radiation therapy).
- •Patient deemed suitable for percutaneous hepatic perfusion.
- •Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
排除标准
- •Life expectancy of less than 6 months.
- •Use of live vaccines four weeks before or after the last study treatment.
- •History of severe reactions to monoclonal antibodies, melphalan, heparin or iodine contrast.
- •Known human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
- •Active autoimmune disease or a documented history of autoimmune disease requiring systemic immunomodulatory treatment. Diabetes, rematoid arthritis, psoriasis, atopic dermatitis and hypothyroidism are excepted.
- •A condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.
- •Has a known additional malignancy that is progressing or requires active treatment.
- •Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the last dose of study drug.
- •A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate in the opinion of the treating investigator.
- •More than 50% of the liver volume replaced by tumor as measured by CT.
- •Extrahepatic disease as measured by CT of thorax and abdomen.
- •History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes the use of general anesthesia.
- •History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia.
- •Patients who are unable to undergo general anesthesia for any reason.
- •Reduced renal function defined as S-Creatinine >=1.5xULN or Creatinine Clearance < 40 mL/min, calculated using the Cockroft and Gault formula.
- •Reduced hepatic function (defined as AST, ALT, bilirubin>2.5*ULN and PK-INR>1.5) or medical history of liver cirrhosis (Child-Pugh Class B or C) or evidence of portal hypertension by history, endoscopy or radiology.
- •Hemoglobin <90 g/L or platelets <100x109/L or neutrophils <1.5x109/L
结局指标
主要结局
Progression-free survival (PFS)
Progression-free survival (PFS)
次要结局
- Predictive and prognostic biomarker discovery
- ctDNA zero-conversion rate at 24 weeks
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
- Objective response rate (ORR)
- Clinical benefit rate (CBR)
- Hepatic progression-free survival (hPFS)
- Extrahepatic progression-free survival (xhPFS)
- Overall survival (OS)
- Melanoma-specific survival (MSS)
- Duration of response (DOR)
- Quality of Life (QoL)
研究者
Roger Olofsson Bagge
Scientific
Vaestra Goetalandsregionen
研究点 (6)
Loading locations...
相似试验
招募中
3 期
PHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver MetastasesUveal MelanomaLiver MetastasesNCT06519266Vastra Gotaland Region40
尚未招募
3 期
SWE-NEO: Swedish NeoAdjuvant Trial Comparing anti-PD-1 Monotherapy to Combined anti-CTLA-4/anti-PD-1 blockade in Resectable Stage III Melanoma2024-519593-39-00Karolinska University Hospital128
已完成
3 期
Dendritic Cells Plus Autologous Tumor RNA in Uveal MelanomaUveal MelanomaNCT01983748University Hospital Erlangen200
招募中
不适用
Retrospective Register for Uveal MelanomaUveal MelanomaNCT05733728Medical University of Vienna1,400
招募中
2 期
Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal MelanomaNCT07276386H. Lee Moffitt Cancer Center and Research Institute18