EUCTR2016-002543-41-ES进行中（未招募）1 期
An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- •- Histologically documented adenocarcinoma of the lung
- •- Stage IIIB or Stage IV disease
- •- Biopsy material available for central assessment of PD-L1 and mesothelin
- •- In Phase 2 only: Mesothelin-positive status
- •- ECOG performance status of 0 or 1
- •- Progressive disease during or after platinum-based doublet chemotherapy, administered in the metastatic setting
- •- Adequate bone marrow function, defined as:
- •Absolute neutrophil count (ANC) =1500/µL (or 1.5×10 to the power of 9/L)
- •Platelets =100,000/µL (or 100×10 to the power of 9/L)
- •Hemoglobin =10.0 g/dL
- •- Adequate hepatic function, defined as:
- •Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) = 1.5 times the upper limit of normal (ULN)
- •Total serum bilirubin =1.5xULN
- •- Adequate renal function, defined as:
- •Calculated creatinine clearance =40 mL/min using the Cockcroft-Gault equation
- •- A woman of childbearing potential must have a negative serum (ß-human chorionic gonadotropin [ß-hCG]) or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of hCG) within 14 days before the first dose of nivolumab and a second negative test within 24 hours before the first dose of nivolumab.
- •- Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies. Further details see protocol
- •- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction while on the study agent and for 5 months after the last dose of study agent
- •- To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on the study agent and for 5 months (female subjects) or 7 months (male subjects) after the last dose of study agent.
- •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 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •- Untreated brain metastases or other active central nervous system (CNS) metastases. Subjects with a history of brain metastasis must have completed treatment for brain metastasis for at least 28 days, and be neurologically stable and off steroids before enrollment (Phase 1b) or randomization (Phase 2).
- •- Tumor with activating EGFR mutation or ALK translocation (EGFR and ALK results must be confirmed in the Screening Period for all non-smokers).
- •- More than 1 prior line of chemotherapy for metastatic disease (not including therapy given in the maintenance setting, or neoadjuvant or adjuvant therapy for locally advanced disease).
- •- History of symptomatic interstitial lung disease.
- •- History of disallowed therapies, as follows:
- •In Phase 1b only: Prior exposure to anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) antibody within 28 days before the first dose of study agent
- •In Phase 2 only: Prior exposure to anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) antibody
- •History of listeriosis or vaccination with a Listeria-based vaccine or prophylactic vaccine (eg, influenza, pneumococcal, diphtheria, tetanus, and pertussis [dTP/dTAP]) within 28 days before the first dose of study agent
- •Chemotherapy within 28 days before the first dose of study agent
- •Radiation within 14 days before the first dose of study agent (exception: palliative radiotherapy for pain can be used = 7 days before or after study agent)
- •- Any uncontrolled active systemic infection, active noninfectious pneumonitis, or any life-threatening illness, medical condition, or organ system dysfunction
- •- Any active autoimmune disease or a documented history of autoimmune disease
- •- History of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNFa) therapies or other immunosuppressant medications during the study.
- •- Known allergy to both penicillin/amoxicillin and trimethoprim/sulfamethoxazole.
- •- Concurrent treatment with anti-TNFa therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immunosuppressive drugs <14 days before randomization. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted.
- •- Positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
- •- History of major implant(s) or device(s)
- •- History of clinically significant cardiovascular disease within 6 months of randomization
- •- Known active or chronic hepatitis B or hepatitis C as demonstrated by hepatitis B surface antigen (HBsAg) positivity and/or anti-hepatitis C virus (HCV) positivity, respectively. Subjects with clinically active or chronic liver disease, including liver cirrhosis, are also excluded.
- •- Active second malignancy within 2 years prior to randomization (exceptions see protocol)
- •- Evidence of active viral, bacterial, or systemic fungal infection requiring systemic treatment within 7 days before the first dose of the study agent.
- •- Known allergies, hypersensitivity, or intolerance to JNJ-757 or nivolumab or its excipients
研究者
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