NCT03430791

Trial of Combination Tumor Treating Fields (TTF; Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma

A Phase I/II Trial of Combination Tumor Treating Fields, Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I/II trial in which participants with recurrent glioblastoma will receive a combination of tumor treating fields(portable device), nivolumab with or without ipilimumab.

Detailed description

Phase I/II trial in which participants with recurrent glioblastoma will receive a combination of tumor treating fields(portable device), nivolumab with or without ipilimumab. The NovoTTF200A (OptuneTM) device is worn continuously for a goal of 75% or more of the time, ranging from at least 18 hours daily uninterrupted or 22 hours daily with 2-3 days off monthly. Therapy is planned for approximately 24 months. Infusions with nivolumab will start within 1 week of study start. Ipilimumab will either start with the second nivolumab infusion or at after tumor progression. Nivolumab is infused intravenously at 240 mg once every 2 weeks with or without ipilimumab for a maximum of 24 months. Ipilimumab is dosed at 1 mg/kg once every 6 weeks for a maximum of 4 doses (24 weeks). Infusions will continue until maximum doses are completed or there is confirmed tumor progression, intolerable adverse effects or withdrawal of consent.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Nivolumab 240 mg IV	Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
DRUG	Nivolumab 3 mg/kg	Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
DRUG	Ipilimumab 1 mg/kg	Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
DEVICE	NovoTTF200A (Optune)	A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.

Timeline

• Start date: 2018-12-05
• Primary completion: 2020-05-29
• Completion: 2021-01-27
• First posted: 2018-02-13
• Last updated: 2023-02-02
• Results posted: 2023-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study