VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Glioblastoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The trial is conducted as a multicenter, open-label, Phase I/II trial to evaluate the efficacy and safety of VXM01 in combination with avelumab in subjects with resectable and non-resectable progressive glioblastoma following tumor resection and radiochemotherapy containing temozolomide. The trial w...
The trial is conducted as a multicenter, open-label, Phase I/II trial to evaluate the efficacy and safety of VXM01 in combination with avelumab in subjects with resectable and non-resectable progressive glioblastoma following tumor resection and radiochemotherapy containing temozolomide. The trial will be performed in 30 subjects with progressive glioblastoma: 24 subjects who will not be candidates for a tumor re-operation (non-resectable subjects) 6 subjects who will be candidates for a tumor re-operation (resectable subjects) The trial, for each subject, will consist of a screening period, a treatment and observatioon phase of 60 weeks including, a treatment phase of up to 48 weeks with prime and boosting administrations of VXM01 in combination with avelumab and an observation phase of 12 weeks and with an end of trial visit at Week 60. Subjects will receive VXM01 in combination with avelumab up to Week 48. The end of study (EoS) visit assessments will be performed Week 60.
Tracking Information
- NCT #
- NCT03750071
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Pfizer
- Investigators
- Principal Investigator: Wolfgang Wick, MD University Clinics Heidelberg
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