NL-OMON48738
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- VAXIMM GmbH
- Enrollment
- 9
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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