Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients (NCT04121455) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients
Germany117 participantsStarted 2019-09-12
Plain-language summary
The purpose of this study is to obtain first, exploratory information on the safety and efficacy of (i) olaptesed pegol in combination with radiation therapy in patients with newly diagnosed glioblastoma of unmethylated MGMT promoter status either not amenable to resection (biopsy only) or after incomplete tumor resection, and (ii) olaptesed pegol in combination with radiation therapy and bevacizumab in patients with newly diagnosed glioblastoma of unmethylated MGMT promoter status either not amenable to resection (biopsy only) or after incomplete or complete tumor resection.
Further arms are included (i) to establish safety for the combination of olaptesed pegol at three different doses in addition to radiotherapy and bevacizumab, (ii) to explore the benefit of combining olaptesed pegol at different dose levels with bevacizumab in order to define the doses to move forward into a subsequent randomized dose-finding study, (iii) to explore the contribution of the therapy components olaptesed pegol and bevacizumab to patient benefit and (iv) to put the clinical outcome of these treatment regimens into perspective with the standard of care treatment with temozolomide and radiotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Age ≥18 years
✓. Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery or biopsy
✓. Patient agrees to subcutaneous port implantation
✓. Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma
✓. Status post biopsy or incomplete resection
✓. Unmethylated MGMT promoter status
✓. Maximum Eastern Cooperative Oncology Group (ECOG) score 2
Exclusion criteria
✕. Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
✕. Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies
What they're measuring
1
Safety - Number of patients with treatment-related adverse events as assessed by CTCAE
Timeframe: through study completion, an average of 3 years
✕. Contra-indication or known hypersensitivity to MRI contrast agents, olaptesed pegol or polyethylene glycol
✕. Cytostatic therapy (chemotherapy) within the past 5 years
✕. History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for ≥ 5 years)
✕. Clinically significant or uncontrolled cardiovascular disease
✕. Prior radiotherapy to the head
✕. Any other previous or concomitant experimental glioblastoma treatments