NL-OMON48738已完成2 期
An open-label, Phase I/II multicenter clinical trial of VXM01 in combination with avelumab in patients with progressive glioblastoma following standard treatment, with or without second surgery. - VXM01 plus Avelumab combination study in progressive glioblastoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- VAXIMM GmbH
- 入组人数
- 9
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 99（—）
入选标准
- •1. Subjects who are able to understand and follow instructions during the trial
- •2. Ability and willingness to give written informed consent, signed and dated
- •3. Male or female subjects. Female subjects must be post-menopausal for at
- •least 2 years or surgically sterile
- •4. Age >=18 years
- •5. Histologically diagnosed intracranial supratentorial malignant glioma
- •(contrast-enhancing glioblastoma WHO Grade IV)
- •6. Evidence of tumor progression by RANO criteria following at least one prior
- •therapy regimen that must have contained radiation and chemotherapy with
- •temozolomide, as measured by MRI
- •* Radiotherapy must have been completed at least 3 months prior to the
- •inclusion visit
- •7. Candidates for a tumor reoperation (for the resectable arm [n=6] only)
- •* Neurosurgical intervention should be postponable for 30 days
- •8. Adequate bone marrow function including: Absolute neutrophil count (ANC)
- •>=1,500/mm3 or >=1.5 x 10^9/L; Platelets >= 100,000/mm3 or >=100 x 10^9/L;
- •Hemoglobin >= 9 g/dL (may have been transfused); INR <1.5x ULN. Subjects with
- •documented benign cyclical neutropenia are allowed if WBC count is >= 1.5 ×
- •10^9/L with absolute neutrophil count >= 1.0 × 10^9/L and appropriate hematology
- •parameters: leukocytes >=4.0 x 10^9 / L, lymphocytes >=0.6 x 10^9/L
- •9. Adequate hepatic function defined by a total bilirubin level <= 1.5 × the
- •upper limit of normal range (ULN), an aspartate aminotransferase (AST), level <=
- •2.5 × ULN, and an alanine aminotransferase (ALT) level <= 2.5 × ULN or, for
- •subjects with documented metastatic disease to the liver, AST and ALT levels <=
- •5 × ULN. Subjects with documented Gilbert disease are allowed if total
- •bilirubin <= 3 x ULN
- •10. Adequate renal function defined by an estimated creatinine clearance >= 30
- •mL/min according to the Cockcroft-Gault formula
- •11. Patients must be able to undergo MRI
- •12. Absence of active bacterial infection requiring antibiotic treatment
- •13. Karnofsky performance status >=70
- •14. Primary (or most recently obtained available) tumor samples available for
- •pathology review, panel sequencing, as well as central detection of T-cell
- •responses in the peripheral blood and in the tumor tissue
- •15. No medical or social conditions that may interfere with trial outcome and
排除标准
- •1. Cardiovascular disease defined as:
- •a. Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic
- •blood pressure >100 mmHg)
- •b. Arterial thromboembolic event within 6 months before trial entry including:
- •* Myocardial infarction
- •* Unstable angina pectoris
- •* Cerebrovascular accident
- •* Transient ischemic attack
- •2. Congestive heart failure New York Heart Association grade III to IV
- •3. Serious ventricular arrhythmia requiring medication and arrhythmias
- •requiring Implantable Cardioverter Defibrillator (ICDs)
- •4. Clinically significant peripheral artery disease > grade 2b according to
- •5. History of relevant intracranial hemorrhage (not confined to susceptibility
- •(iron) lesions on MRI only)
- •6. Hemoptysis within 6 months before trial entry
- •7. Known oesophageal varices
- •8. Upper or lower gastrointestinal bleeding within 6 months before inclusion
- •9. Significant traumatic injury or surgery within 4 weeks before trial entry
- •10. Non-healing wound, incomplete wound healing, bone fracture or
- •gastrointestinal ulcers within three years before inclusion, or positive
- •gastroscopy within 3 months before inclusion
- •11. Gastrointestinal fistula
- •12. Thrombolysis therapy within 4 weeks before trial entry
- •13. History of other disease, metabolic dysfunction, physical examination
- •finding, or clinical laboratory finding that based on the investigators
- •judgement provides a reasonable suspicion of a disease or condition that
- •contraindicates the use of an investigational drug or that might affect the
- •interpretation of the trial results or render the patient at high risk for
- •treatment complications
- •14. Previous malignant disease (other than the tumor disease for this trial)
- •within the last 5 years (except adequately treated non-melanoma skin cancers,
- •carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate)
- •unless a complete remission without further recurrence was achieved at least 2
- •years prior to trial entry and the subject was deemed to have been cured with
- •no additional therapy required or anticipated to be required
- •15. Prior organ transplantation, including allogeneic stem cell transplantation
- •16. Active autoimmune disease that might deteriorate when receiving an
- •immunostimulatory agent:
- •a. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid
- •disease not requiring immunosuppressive treatment are eligible
- •b. Administration of steroids through a route known to result in a minimal
- •systemic exposure (topical, intranasal, intro-ocular, or inhalation) are
- •17. History of uncontrolled intercurrent illness including but not limited to
- •uncontrolled diabetes (e.g., hemoglobin A1c >= 8%)
- •18. Known prior hypersensitivity to investigational product or any component in
- •its formulations or any other drug scheduled or likely to be given during the
- •trial, including known severe hypersensitivity reactions to monoclonal
- •antibodies (NCI CTCAE v5.0 Grade >= 3)
- •19. Persisting toxicity related to prior therapy (NCI CTCAE v5.0 Grade > 1);
- •however, alopecia, sensory neuropathy Grade <= 2, or other Grade <= 2 AEs not
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