2023-508658-24-00招募中2 期
EORTC-1525-LCG: Single-arm, multicenter, phase II study of immunotherapy in patients with type B3 thymoma and thymic carcinoma previously treated with chemotherapy - (Nivothym)
European Organisation For Research And Treatment Of Cancer13 个研究点 分布在 4 个国家目标入组 99 人开始时间: 2024年8月20日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 13
- 主要终点
- Progression Free Survival Rate at 6 months (PFSR-6) per independent radiological review
研究概览
简要总结
To assess PFS rate (PFSR) at 6 months in patients treated with nivolumab or the combination of nivolumab and ipilimumab, with relapsed/advanced thymic carcinoma and type B3 thymoma not amenable to curative-intent radical treatment and previously treated with platinum-based chemotherapy
研究设计
- 研究类型
- Interventional
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
- •Relapsed/advanced thymoma B3 or thymic carcinoma not amenable to curative-intent radical treatment
- •Adequate renal function: calculated creatinine clearance ≥50 mL/min (according to Cockroft-Gault, see below); -Female CrCl = ((140 - age in years) x weight in kg x 0.85)/ 72 x serum creatinine in mg/dL; -Male CrCl = ((140 - age in years) x weight in kg x 1.00)/72 x serum creatinine in mg/dL
- •Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment
- •Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 5 months for a woman and 7 months for a man after the last study treatment.
- •Female patients who are breast feeding should discontinue nursing prior to the first dose of study medication and must not breast feed during the trial treatment and for a period of at least 5 months following the last administration of trial drug(s)
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •At least one previous line of platinum-based chemotherapy for advanced disease
- •Radiological progression documented per RECIST 1.1 during or after completion of previous line therapy
- •Presence of measurable disease according to RECIST 1.
- •At least 18 years
- •WHO Performance Status (PS) 0-2
- •Availability of FFPE tumor tissue (preferentially a tumor block or 10 unstained slides), notably for PD-L1 immunohistochemistry (IHC) expression assessment. Archival material is allowed. Tissue must be considered adequate (assessed by a local pathologist) for characterization of PD-L1 status as per procedure manual
- •Adequate hematological function: -White blood count ≥ 2 × 109/L; -Haemoglobin >9 g/dL; -Platelet count >100 × 109/L
- •Adequate liver function: -Total bilirubin <1.5 × ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL); -LT and/or AST <2.5 × ULN (< 4 x ULN in case of liver metastasis) -Alkaline phosphatase <5 × ULN
排除标准
- •Any evidence of active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable (i.e. without evidence of progression by imaging for at least four weeks prior to enrollment and any neurologic symptoms have returned to baseline), and have not received steroids (for a total equivalent dose of more than 10 mg of prednisone per day) for at least 7 days prior to enrollment
- •Autoimmune paraneoplastic syndrome requiring immunosuppressive or dedicated treatment. Particular attention should be given to detecting any minor myasthenia signs or positive autoantibodies at enrollment
- •History of any other hematologic or primary solid tumor malignancy, unless in remission for at least 5 years. pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanomatous skin cancer or carcinoma in situ of the cervix are allowed
- •Previous allogeneic tissue/solid organ transplant
- •Active infection requiring therapy
- •Surgery or chemotherapy related toxicity that have not resolved to a grade 1, with the exception of alopecia, fatigue, neuropathy and lack of appetite /nausea
- •Severe comorbidities that in the opinion of the investigator might hamper participation to the study and/or treatment administration
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Prior treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators
- •Presence of acetylcholine receptor antibodies
- •Current participation in any other clinical research or treatment with an investigational agent or use of an investigational device within 4 weeks of enrollment
- •Known active Hepatitis B (e.g., positive HBsAg result) or C (e.g., HCV RNA[qualitative] is detected) or known history or current evidence of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies)
- •If CT has to be used, known contra-indications for CT with IV contrast
- •History of interstitial lung disease (ILD) OR pneumonitis (other than COPD exacerbation) that has required oral or IV steroids
- •Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed
- •Live vaccines within 30 days prior to the first dose of study therapy and while participating in study. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, H1N1 flu, rabies, BCG, and typhoid vaccine.
结局指标
主要结局
Progression Free Survival Rate at 6 months (PFSR-6) per independent radiological review
Progression Free Survival Rate at 6 months (PFSR-6) per independent radiological review
次要结局
- Progression Free Survival Rate at 6 months (PFSR-6) according to RECIST 1.1 per local investigator assessment
- Safety according to CTCAE v4.0
- Overall Response Rate (ORR) according to RECIST 1.1 per local investigator assessment
- Disease Control Rate according to RECIST 1.1 per local investigator assessment (DCR)
- Duration of response according to RECIST 1.1 per local investigator assessment
- Progression Free Survival (PFS) according to RECIST 1.1 per local investigator assessment
- Overall Survival (OS)
- Progression Free Survival for patients continuing treatment after progression
研究者
Stéphanie Kromar
Scientific
European Organisation For Research And Treatment Of Cancer
研究点 (13)
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