A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant with Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant with Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513550-30-00

Acronym

EF-41/KEYNOTE D58

Enrollment

280

Registered

2025-01-27

Start date

2025-03-28

Completion date

Unknown

Last updated

2025-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed Glioblastoma

Brief summary

Detailed description

1. PFS per RANO 2.0 as assessed by investigator, 2. PFS per RANO as assessed by investigator, 3. PFS6m and PFS12m per RANO 2.0 as assessed by investigator, 4. PFS2 per RANO 2.0 as assessed by investigator, 5. 1- and 2-year survival rates, 6. The EORTC QLQ-C30 with BN20 module score, 7. Subjects experiencing AEs

Interventions

DRUGTEMOZOLOMIDE

DRUGsaline solution for infusion

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
OS	—

Secondary

Measure	Time frame
1. PFS per RANO 2.0 as assessed by investigator, 2. PFS per RANO as assessed by investigator, 3. PFS6m and PFS12m per RANO 2.0 as assessed by investigator, 4. PFS2 per RANO 2.0 as assessed by investigator, 5. 1- and 2-year survival rates, 6. The EORTC QLQ-C30 with BN20 module score, 7. Subjects experiencing AEs	—

Countries

Czechia, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026