NCT03419403

UNITE Study: Understanding New Interventions With GBM ThErapy

Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafodotin (ABT-414).

Detailed description

This Phase 3b open-label, randomized, exploratory study included 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide \[RT/TMZ\]) and adjuvant therapy (TMZ). All participants received depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids; standard steroids with vasoconstrictors and cold compress; and enhanced steroids with vasoconstrictors and cold compress. The study comprised a screening period of up to 7 weeks after surgery, a 6-week concomitant Chemoradiation Phase, an Adjuvant Phase beginning approximately 4 weeks after completion of chemoradiation, and a Follow-Up Phase.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Steroid eye drops	Solution, eye drop
DRUG	Vasoconstrictor eye drops	Solution, eye drop
OTHER	Cold compress	Cold compress
DRUG	Ophthalmic steroid ointment	Ointment
DRUG	Depatuxizumab mafodotin	During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles.
DRUG	Temozolomide	Temozolomide was to be administered according to the local standard of care. Duration of treatment was to be 6 - 12 cycles in the adjuvant phase and at the discretion of the investigator as supported by local standard of care.
RADIATION	Radiation	Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.

Timeline

• Start date: 2018-07-30
• Primary completion: 2019-09-05
• Completion: 2020-03-03
• First posted: 2018-02-05
• Last updated: 2021-04-14
• Results posted: 2021-04-14

Locations

22 sites across 5 countries: United States, Australia, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study