EUCTR2015-002552-27-GB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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 671
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
- •1. Histological or cytological diagnosis of advanced/metastatic solid tumor as follows
- •For all combinations:
- •Measurable disease by RECIST v1.1 with at least 1 measurable lesion that has not previously been irradiated.
- •Availability of tumor specimens: For Phase 1b: Archival formalin-fixed paraffin-embedded (FFPE) tissue is required if available for the first 3 patients enrolled in a cohort, including replacement patients. For additional patients enrolled in each Phase 1b cohort and Phase 2, FFPE tissue must be available from the most recent primary or metastatic tumor biopsy or resection prior to start of study therapy, taken within 1 year prior to study entry, with no intervening systemic anti-cancer therapy. De novo, excision, fine needle biopsies may be used
- •The following baseline data should be available for each respective tumor type: human papilloma virus (HPV) status based on locally approved testing for patients with SCCHN, EGFR, ALK and ROS-1 status for non-squamous NSCLC and PD-L1 status based on locally approved testing for first-line NSCLC patients.
- •Unless specified, the prior therapy requirements apply to anti-cancer drug treatment in advanced stage/metastatic disease. If patient relapses within 1 year of adjuvant/neoadjuvant treatment, the respective therapy must be counted as treatment in advanced disease/metastatic setting.
- •Combination A
- •Phase 1b: NSCLC that has progressed on standard therapy or for which no standard therapy is available.
- •A1 – A5: NSCLC, melanoma, or SCCHN in any line of therapy; NSCLC patients with tumor anaplastic lymphoma kinase (ALK) translocations or epidermal growth factor receptor (EGFR) mutations must have received, or been refractory/intolerant to standard therapy.
- •A6: TNBC that has progressed after 1 line of therapy or is ineligible for/intolerant to SOC; or
- •A7: SCLC that has progressed after up to 1 line of prior therapy in advanced metastatic setting or is ineligible for/intolerant to standard of care (SOC). No prior PD-1/PD-L1 therapy allowed.
- •A8, A9, and A10: NSCLC first-line Stage IV or recurrent NSCLC that is histologically proven and is demonstrated to express PD-L1. Patients must not have received treatment for their metastatic or recurrent disease. Neither activating EGFR mutation nor ALK or ROS1 translocation/rearrangement are permitted (non-squamous cell
- •histologies require testing if status is unknown).
- •Patients could have received adjuvant chemotherapy or locoregional treatment that included chemotherapy for locally advanced disease as long as disease treatment occurred at least 6 months prior to study entry. No prior PD-1/PD-L1 therapy allowed.
- •Combination B
- •Phase 1b:NSCLC, melanoma, or SCCHN that has progressed after at least 1 line of standard therapy or is ineligible for/intolerant to SOC; No prior PD-1/PD-L1 therapy allowed.
- •Phase 2:NSCLC, Cutaneous or mucosal metastatic melanoma, SCCHN: Up to 2 lines of prior therapy in advanced/metastatic disease settings allowed. No prior PD-1/PD-L1 therapy allowed.
- •Combination C
- •NSCLC, SCCHN: Up to 2 lines of prior therapy in advanced/metastatic disease settings allowed. Gastric cancer that has progressed after at least 1 line or is ineligible for/intolerant to SOC and not more than 2 lines of standard therapy in advanced/metastatic disease settings or is ineligible for/intolerant to SOC.
- •Platinum resistant ovarian cancer that has not received more than 2 lines of standard therapy in the platinum res
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 history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) related illness
- •12. Existing periorbital edema
- •13. Hypocalcemia (serum albumin adjusted calcium <7.5 mg/dL), clinically significant bone disease that may affect safe study participation at the discretion of the investigator, or recent bone fracture (within 12 weeks prior to study entry).
- •14. Active infection requiring systemic therapy
- •15. Positive HBV or HCV test indicating acute or chronic infection
- •16. Administration of a live vaccine within 4 weeks prior to study entry
- •17. 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
- •18. 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
- •19. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation
- •20. Persisting toxicity related to prior therapy >Grade 1 (alopecia and Grade =2 sensory neuropathy, or other Grade =2 AEs not constituting a safety risk based on Investigator judgment are acceptable); previous Grade =3 irAE within 3 months prior to study entry; or unresolved irAEs prior to study entry.
- •21. 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
- •22. 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 90 days after the last dose of investigational product
- •23. Combination E only: Current use or anticipated need for food or drugs that are known strong CYP1A2 inhibitors, inc
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