NCT04121455

Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients

Single-arm, Dose-escalation Phase 1/2 Study of Olaptesed Pegol (NOX-A12) in Combination With Irradiation in Inoperable or Partially Resected First-line Glioblastoma Patients With Unmethylated MGMT Promoter With a Multiple-arm Expansion Group

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: TME Pharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Olaptesed pegol	Olaptesed pegol continuous i.v. administration
RADIATION	Radiotherapy	Radiotherapy in weeks 1-6; cumulative dose of 60 Gy in 2 Gy fractions
DRUG	Bevacizumab	Bevacizumab every 2 weeks i.v. infusion
DRUG	Pembrolizumab	Pembrolizumab every 3 weeks i.v. for 26 weeks
DRUG	Temozolomide (TMZ)	oral treatment according to current SPC

Timeline

• Start date: 2019-09-12
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2019-10-10
• Last updated: 2025-06-25

Locations

6 sites across 1 country: Germany