EUCTR2015-002552-27-DE进行中（未招募）1 期
A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB* (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES - JAVELIN Medley
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 147
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
入选标准
- •1. Histological or cytological diagnosis of advanced/metastatic solid tumor. For Phase 1b, patients with NSCLC that have progressed on standard therapy or for which no standard therapy is available, and for Phase 2, patients with NSCLC (ALK/EGFR mutation negative), melanoma, and SCCHN with no restrictions for line of therapy. NSCLC patients in Phase 2 with tumor ALK or EGFR mutations must have received or been refractory/intolerant to standard therapy
- •2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •3. Estimated life expectancy of at least 3 months
- •4. Adequate bone marrow, renal, and liver function
- •5. Resolved acute effects of prior therapy to baseline severity or =Grade 1 except for AEs not constituting a safety risk by investigator judgement
- •6. Negative serum pregnancy test at screening (females of childbearing potential)
- •7. Male and female patients able to have children must agree to use 2 highly effective methods of contraception throughout the study and for at least 60 days after last dose
- •8. Signed and dated informed consent
- •9. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other procedures
- •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 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 59
排除标准
- •1. Systemic chemotherapy within 28 days prior to study entry
- •2. Current or prior use of immunosuppressive medication within 7 days prior to study entry
- •3. Active autoimmune disease requiring systemic steroids or immunosuppressive agents within 7 days prior to study entry
- •4. Known prior or suspected hypersensitivity to investigational products, including known severe hypersensitivity reactions to monoclonal antibodies (Grade =3), and any history of anaphylaxis or uncontrolled asthma
- •5. Major surgery within 4 weeks or radiation therapy within 14 days prior to study entry
- •6. Patients with known symptomatic brain metastases requiring steroids
- •7. Previous high-dose chemotherapy requiring stem cell rescue
- •8. Prior allogeneic stem cell transplant or organ graft
- •9. Any of the following within 6 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
- •10. Deep vein thrombosis or symptomatic pulmonary embolism within 6 months prior to study entry
- •11. Known HIV or AIDS-related illness
- •12. Active infection requiring systemic therapy
- •13. Positive HBV or HCV test indicating acute or chronic infection
- •14. Administration of a live vaccine within 4 weeks prior to study entry
- •15. Diagnosis of other malignancy within 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix, or low-grade (Gleason =6) prostate cancer
- •16. Patients who are site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study
- •17. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation
- •18. Persisting toxicity related to prior therapy >Grade 1
- •19. Other severe acute or chronic medical condition, including colitis, inflammatory bowel disease, and pneumonitis or psychiatric condition, recent or active suicidal ideation or behavior, or end stage renal disease on hemodialysis, or laboratory abnormality that may increase the risk associated with study participation or investigational products administration or may interfere with the interpretation of results and, in the judgment of the Investigator, would make the patient inappropriate study entry
- •20. Male and female patients able to have children who are unwilling or unable to use 2 highly effective method(s) of contraception for the duration of the study and for at least 60 days after the last dose of investigational product
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