2026-525445-73-00招募中2 期
Pilot study with Low-dose nivolumab in Advanced Neoplasms that are TMB-high
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- UZ Brussel
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
Determine the efficacy/potential of low-dose nivolumab in TMB-high patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- •Male or female age ≥ 18 years at the time of informed consent
- •All subjects must have histologically confirmed advances solid tumor that is TMB-high and have failed all standard curative and live prolonging therapy.
- •ECOG performance status of 0 or 1
- •Adequate organ function determined within 14 days prior to enrollment, defined as follows: a. Hematological i. Absolute neutrophil count ≥ 1500/mm3 (1.5x109/L) ii. Platelet count: ≥ 100.000/mm3 (7.5x109/L) iii. Hemoglobin: ≥ 9 g/dL (without need for hematopoietic growth factor or transfusion support) b. Renal i. Serum creatinine: 1.5 x upper limit of normal (ULN), OR 24-hour creatinine clearance ≥ 60 mL/min for subject with creatinine levels > 1.5 x ULN. (Note: Creatinine clearance need not be determined if the baseline serum creatinine is within normal limits. Creatinine clearance should be calculated per institutional standard). c. Hepatic i. Serum bilirubin: 1.5 x ULN OR direct bilirubin ≤ ULN for a subject with to-tal bilirubin level > 1.5 x ULN ii. Aspartate aminotransferase (AST): 2.5 x ULN OR ≤ 5 x ULN for subject with liver metastases iii. Alanine aminotransferase (ALT): 2.5 x ULN OR ≤ 5 x ULN for subject with liver metastases
- •Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to enrollment. If urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Subject has a tumor sample (archival or new biopsy). Subject must submit the tumor sample during screening to be able to perform the TMB-high testing.
排除标准
- •Access to treatment with ICIs in the reimbursed setting
- •Other investigational procedures while participating in this study are excluded.
- •Evidence of clinically significant immunosuppression such as the following: i. Diagnosis of immunodeficiency ii. Concurrent opportunistic infection iii. Receiving systemic immunosuppressive therapy (> 2 weeks) or within 7 days prior to the first dose of study treatment, including oral steroid doses > 10 mg/day of prednisone or equivalent except for management of adverse events and central nervous system (CNS) metastases during the course of the study. Subjects that require intermittent use of bronchodilators or local steroid injection will not be excluded from the study.
- •Known human immunodeficiency virus (HIV) disease
- •Known acute or chronic hepatitis B or hepatitis C infection
- •Known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids >8 mg/day of methylprednisone or equivalent. The exception does not include carcinomatosus meningitis which is excluded regardless of clinical stability.
- •History or evidence of immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia)
- •History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, or active autoimmune disease or syndrome that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •History of other malignancy within the past 5 years with the following exceptions:
- •Malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for > 5 years before enrollment and felt to be at low risk for re-currence by the treating physician i. Adequately treated non-melanoma skin cancer without evidence of disease at the time of enrollment ii. Adequately treated cervical carcinoma in situ without evidence of disease at the time of enrollment iii. Adequately treated breast ductal carcinoma in situ without evidence of disease at the time of enrollment iv. Prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of en-rollment v. Adequately treated superficial or in-situ carcinoma of the bladder without evidence of disease at the time of enrollment
- •Prior treatment with an immune checkpoint inhibitor
- •Prior chemotherapy, radiotherapy, biological cancer therapy, targeted therapy, or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment.
- •Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study
- •Expected to require another cancer therapy while on study with the exception of local radiation treatment to the site of bone and other metastasis for palliative pain management
结局指标
主要结局
Overall response rate (ORR)
Overall response rate (ORR)
次要结局
未报告次要终点
研究者
Sofie Joris
Scientific
UZ Brussel
研究点 (1)
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