EUCTR2016-001925-15-DE进行中（未招募）1 期
Evaluation of immunological effects of the RANKL-inhibitor Denosumab when administered concurrently with PD1-blocking antibodies (Nivolumab, Pembrolizumab) in patients with metastatic malignant melanoma with bone involvement - BONEMET
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Alcedis GmbH
- 入组人数
- 20
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
- All
入选标准
- •Provision of tumor tissue from metastatic site of disease for biomarker analyses and confirmation by central laboratory. Tumor tissue must be obtained before PD-1 inhibitor therapy (either baseline FFPE sample or archival tissue (ideally obtained after preceding medical tumor therapies).
- •Inoperable metastatic stage IV melanoma arising from a primary cutaneous site or metastatic from an unknown primary site or melanoma of mucosal or uveal origin.
- •Planned therapy with PD-1 blocking antibody (nivolumab or nivolumab + ipilimumab or pembrolizumab) and denosumab as standard of care.
- •Measurable disease according to RECIST1.1 and at least one documented bone metastasis.
- •Age 18 years or above.
- •Written, informed consent.
- •Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- •Minimum life expectancy of 6 months
- •ECOG performance status of 0-2
- •Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration:
- •WBC = 2000/µL
- •Neutrophils = 1000/µL
- •Platelets = 100 x103/µL
- •Hemoglobin = 9.0 g/dL
- •Serum creatinine = 2.0 x ULN OR
- •Creatinine clearance (CrCl) = 35mL/min (using the Cockcroft-Gault formula)
- •AST/ALT = 3 x ULN, in case of liver metastases = 5 x ULN
- •Total Bilirubin = 2.0 x ULN (except subjects with Gilbert Syndrome, who may have total bilirubin up to 5 x ULN)
- •Serum calcium or albumin-adjusted serum calcium within normal limits
- •Prior radiotherapy must have been completed prior to study drug administration
- •Negative pregnancy test for female subjects within the week before treatment start and effective contraception for both male and female subjects if the risk of conception exists
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Prior therapy with CTLA4-inhibitor or PD-1-inhibitor or denosumab for distant metastatic disease. Treatments in the adjuvant setting are allowed in case treatment was discontinued at least 4 weeks before inclusion in this study.
- •No other concurrent medical treatments for metastatic disease such as targeted therapies or chemotherapies are allowed. Treatments in the adjuvant setting are allowed in case treatment was discontinued at least 4 weeks before inclusion in this study.
- •Active CNS metastases requiring local therapy or steroid therapy.
- •Use of any investigational or non-registered product (drug or vaccine) within the past 30 days before study start and during study.
- •Psychiatric or addictive disorders of the patient that may compromise his/her ability to give informed consent or to comply with the trial procedures.
- •Significant dental/oral disease, including prior history or current evidence of osteonecrosis/osteomyelitis of the jaw, or the following: Active dental or jaw condition which requires oral surgery. Non-healed dental/oral surgery. Planned invasive dental procedures for the course of the study.
- •Relevant immune deficiencies or relevant autoimmune disease, as assessed by the investigator.
- •Other malignancies within the past three years which need treatment except basal or squamous skin carcinomas or carcinoma in situ of the cervix
- •Serious cardiac, gastrointestinal, hepatic or pulmonary disease
- •Patients with serious intercurrent illness, requiring hospitalization.
- •Other serious illnesses, e.g., serious infections requiring intravenous antibiotics or bleeding disorders.
- •Hypersensitivity to the active substances of study treatment or to any of the excipients (calcium, vitamin D)
- •Hereditary fructose intolerance
- •Women of childbearing potential: Refusal or inability to use highly effective means of contraception
- •For female patients: the patient is pregnant or lactating or planning to become pregnant within 5 months after the end of the treatment.
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