EUCTR2018-004138-13-GB进行中（未招募）1 期
A multicentre phase II non-randomised trial assessing the efficacy of DKN-01 plus atezolizumab in patients with advanced mismatch repair proficient oesophagogastric cancer - WAKING: Wnt and checKpoint INhibition in Gastric cancer
THE ROYAL MARSDEN NHS FOUNDATIO0 个研究点目标入组 52 人开始时间: 2020年10月20日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
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.Signed Informed Consent Form
- •2.Male or female patients age =18 years at time of signing Informed Consent Form
- •3.Ability to comply with the study protocol, in the investigator's judgment
- •4.Histologically or cytologically confirmed advanced or metastatic gastroesophageal adenocarcinoma. Patients with HER2 positive cancer are permitted after having received HER2 targeted therapy in first line as per Standard of Care
- •5.Disease progression during or following treatment with one or two lines of treatment for advanced disease, one of which must have been a platinum and fluoropyrimidine combination.
- •6.Measurable, or non-measurable but evaluable, disease per RECIST v1.1
- •7.Evidence of tumor mismatch repair proficiency and/or MSI stability must be documented through testing of a representative tumor tissue specimen using immunohistochemistry for MMR proteins or MSI testing. Local testing or historical results of archival tumour tissue is satisfactory for trial entry
- •8.ECOG 0-1
- •9.Life expectancy > 3 months as per physician judgement
- •10.Adequate hematologic and end-organ function, defined by the following laboratory test results obtained within 14 days prior to initiation of study treatment:
- •- ANC greater = 1.5 x 109/L without granulocyte colony-stimulating factor support
- •- Lymphocyte count = 0.5 x109/L
- •- Platelet count = 100 x 109/L without transfusion
- •- Hemoglobin = 90 g/L (9 g/dL) (patients may be transfused to meet this criterion)
- •- AST, ALT, and alkaline phosphatase (ALP) = 2.5 x upper limit of normal (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: ALP = 5 x ULN
- •iii.Serum bilirubin = 1.5 x ULN with the following exception:
- •-Patients with known Gilbert disease: serum bilirubin level = 3 x ULN
- •-Serum creatinine = 1.5 x ULN or Creatinine clearance (CrCl) = 50 mL/min (calculated using the Cockcroft-Gault formula)
- •-Serum albumin = 25 g/L (2.5 g/dL)
- •11.For patients not receiving therapeutic anticoagulation: INR or aPTT = 1.5 x ULN
- •12.For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- •13.Negative hepatitis B surface antigen (HBsAg) test at screening
- •14.Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) DNA = 500 IU/mL at screening
- •15. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- •16.Tumour is amenable to safe repeated biopsies and patient agrees to undergo biopsies for translational endpoints.
- •17.In patients who are receiving anticoagulation, stopping anticoagulation for biopsies must be deemed safe by the treating team.
- •28.Tumours should be advanced and inoperable or metastatic
- •29.Patients on oral anticoagulation are required to change to low molecular weight heparin prior to study entry to be eligible. In patients who are receiving anticoagulation, stopping anticoagulation for biopsies must be deemed safe by the treating team.
- •30.Patient is fit to undergo all protocol investigations and receive all protocol treatment based on the assessment oncology clinics
- •31.Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans
- •32.Pregnancy must be excluded with a negati
排除标准
- •1. Any contraindication or known hypersensitivity reaction to any of the study drugs
- •2. Persisting toxicity relating to prior therapy of >grade 1 CTCAE version 5.0 except alopecia of any grade and neuropathy = grade 2, or other grade =2 not constituting a safety risk based on investigators judgement
- •3. Any prior treatment with immunotherapy including anti-PD-1or PD-L1 therapy.
- •4.Active or untreated CNS metastases are excluded. Patients with treated and asymptomatic CNS metastases are eligible, if they meet all of the following:
- •a.Evaluable or measurable disease outside the CNS
- •b.No metastases to midbrain, pons, medulla, or within 10 mm of the optic nerves and chiasm
- •c.No history or evidence of intracranial haemorrhage or spinal cord haemorrhage
- •d.No evidence of clinically significant vasogenic oedema
- •e.Not on corticosteroids for = 2 weeks; anti-convulsants at a stable dose are allowed.
- •f.No evidence of clinical and radiographic disease progression in the CNS = 3 weeks after radiotherapy or surgery.
- •5. Known severe hypersensitivity reactions to monoclonal antibodies (Grade = 3 NCI CTCAE v 5.0), any history of anaphylaxis.
- •6. Any Immunodeficiency disorders
- •7.Patients with another active malignancy or a prior malignancy within the past 5 years are excluded, except patients with completely resected cutaneous melanoma (early stage), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and localized prostate cancer are eligible.
- •8. History of autoimmune disease except for the following:
- •- Patients with autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
- •- Patients with controlled type 1 diabetes mellitus on a stable dose of insulin regimen are eligible
- •- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermayologic manifestations only (e.g. patients with psoriatic arthritis) are permitted provided that they meet the following conditions:
- •- Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
- •- Rash must cover less than 10% of body surface area
- •- Disease is well controlled at baseline and only requiring low-potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)
- •- No acute exacerbations of underlying condition within the last 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral steroids)
- •16. History of idiopathic pulmonary fibrosis, organizing pneumonia, bronchiolitis obliterans, drug-induced pneumonitis, or idiopathic pneumonitis Patients with radiation pneumonitis within the radiation field are eligible.
- •17. Prior organ transplantation, including allogeneic transplant
- •18. Significant infection requiring systemic therapy:
- •a.HIV infection
- •b.Active tuberculosis infection
- •c.Severe infections within 2 weeks prior to Cycle 1 Day 1
- •d.Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
- •e.Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract
- •f.infection or chronic obstructive pulmonary disease) are eligible
- •g.Active or chronic viral hepatitis B or C infection
- •i.Patients with hepatitis B virus (HBV) infection are eligible if test for hepatitis B
- •1.surface antigen (HBsAg) and HBV DNA are negative
- •ii.Patients with h
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