NL-OMON49178招募中2 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 - M16BAC - VHIO 16001 - CT3
Vall D'Hebron Institute of Oncology (VHIO)0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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
- •-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
- •* 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
- •*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
- •-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.
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 thebreast.· 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 <br
研究者
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