NCT03750071

VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vaximm GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

VXM01 in combination with avelumab in n=30 patients with progressive glioblastoma following standard treatment, with or without second surgery

Detailed 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 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.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	VXM01	Ty21a transformed with a eukaryotic VEGFR-2 Expression Plasmid
BIOLOGICAL	Avelumab	Monoclonal anti-PD-L1 Antibody

Timeline

• Start date: 2018-11-21
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2018-11-21
• Last updated: 2022-10-20

Locations

2 sites across 1 country: Germany