EUCTR2016-002001-19-NL进行中（未招募）1 期
A phase II open-label study with the anti-PD-L1 Atezolizumab monoclonal antibody in combination with Bevacizumab in patients with advanced chemotherapy resistant colorectal cancer and MSI-like molecular signature
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
- VHIO
- 入组人数
- 58
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
- •· Written informed consent must be given according to ICH/GCP and national/local regulations.
- •· Histological or cytological proof of metastatic CRC.
- •· Disease progression or relapse after at least one line of treatment for advanced CRC with a fluoropyrimidine containing chemotherapy as single agent or in combination (combinations with oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab are allowed).
- •· Written documentation of positivity for MSI-like gene signature as determined by Agendia test.
- •· Unresectable disease, with at least one measurable lesion according to RECIST 1.1.
- •· Age = 18 years.
- •· WHO performance status of 0-1.
- •· Ability and capacity to comply with study and follow-up procedures.
- •· Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 28 calendar days prior to the first study treatment:
- •- ANC > 1.5 x 109/L (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
- •- WBC counts > 2500/µL
- •- Platelet count > 100,000/ µL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
- •- Hemoglobin > 9.0 g/dL
- •- AST, ALT, and alkaline phosphatase < 2.5 x ULN, with the following exceptions:
- •i Patients with documented liver metastases: AST and ALT < 5 x ULN
- •ii Patients with documented liver or bone metastases: alkaline phosphatase < 5 x ULN
- •- Bilirubin <1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level < 3 x ULN may be enrolled.
- •- PT and PTT <1.5 x ULN, unless on a stable dose of warfarin
- •- Serum albumin > 2.5 g/dL
- •- Creatinine clearance > 30 mL/min (Cockcroft-Gault formula or based on 24-hour urine collection)
- •- Protein < 2+ on dipstick urinalysis or = 1.0 g in a 24-hour urine collection. All patients with =2+ protein on dipstick urinalysis at baseline must undergo a 24-hour urine collection for protein.
- •· Women of child bearing potential (WOCBP) must have a negative serum pregnancy test before registration.
- •· 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 6 months after the last bevacizumab treatment (for women and men) and 5 months
- •after the last atezolizumab treatment (for women) . A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
- •· Female subjects who are breast feeding should discontinue nursing before trial registration and until 6 months after the last bevacizumab treatment and 5 months after the last atezolizumab treatment.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •· Any treatment with investigational drugs within 28 d prior to Cycle 1, Day 1.
- •· Previous cytotoxic agent within 14 d of planed treatment initiation.
- •· Active or untreated CNS metastases as determined by computed CT or MRI
- •· Radiotherapy within 14 d prior to Cycle 1, Day 1.
- •· Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •· Previous (within the last 5 y) or concurrent malignancies, with the exception of those treated with expected curative outcome as cone-biopsied in situ carcinoma of the cervix, basal cell carcinoma of the skin, localized prostate cancer or ductal carcinoma in situ of the
- •· Life expectancy of < 12 w.
- •· History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- •· Positive test for HIV.
- •· Active hepatitis B or hepatitis C.
- •· Active tuberculosis.
- •· Severe infections within 4 w prior to Cycle 1, Day 1.
- •· Infection within 2 w prior to Cycle 1, Day 1.
- •· Received therapeutic oral or IV antibiotics within 2 w prior to Cycle 1, Day 1.
- •· Significant cardiovascular or cerebrovascular disease
- •· Major surgical procedure within 28 d prior to cycle 1, day 1, or planned procedure or surgery during the study.
- •· Prior allogeneic stem cell or solid organ transplant.
- •· Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
- •· Prior treatment with CD137 agonists, anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapeutic antibody or immune-related pathway-targeting agents.
- •· Current or recent use of dipyridamole, ticlopidine, clopidogrel, or cilostazol .
- •· Unstable dose in the last 2 w prior to the first study treatment of prophylactic or therapeutic low molecular-weight heparin, direct thrombin inhibitors, or warfarin. Stable dose is permitted where appropriate anticoagulation indices are stable.
- •· Inadequately controlled hypertension.
- •· Prior history of hypertensive crisis or hypertensive encephalopathy.
- •· Significant vascular disease within 6 m prior to Cycle 1, Day 1.
- •· Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the bevacizumab or atezolizumab formulation.
- •· Evidence of bleeding diathesis or clinically significant coagulopathy.
- •· Patients with history of pulmonary hemorrhage/hemoptysis within 6 m prior to Cycle 1, Day 1.
- •· Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 calendar days prior to the first dose of bevacizumab.
- •· History of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 m prior to Cycle 1, Day 1.
- •· Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.
- •· Evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
- •· Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture.
- •· History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis ass
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