Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06556563 | EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma | PHASE3 | RECRUITING | 741 | — | — | Feb 3, 2025 | Apr 1, 2029 | May 1, 2026 | 93 | United States, Canada +10 |
| NCT03405792 | Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP) | PHASE2 | ACTIVE NOT_RECRUITING | 40 | — | — | Feb 23, 2018 | Dec 1, 2027 | Feb 6, 2026 | 1 | United States |
Overall survival (OS) is defined as the time from randomization to death due to any cause
Time from enrollment to progression or death or censoring, whichever occurs first. The study team will use the one-sample log-rank test to compare PFS in the triple combination arm relative to the historical control arm to determine whether the triple combination treatment increases PFS in newly diagnosed GBM patients when compared to TTFields+TMZ historical control patients from the EF-14 study. Evaluability for progression free survival required participants to receive adjuvant TMZ, Optune and at least 1 dose of pembrolizumab.
| Arm | Type | Description |
|---|---|---|
| Treatment Group | EXPERIMENTAL | - |
| Control Group | PLACEBO_COMPARATOR | - |
| Optune System combined with Temozolomide (TMZ) + Pembrolizumab | EXPERIMENTAL | Patients with newly-diagnosed GBM who undergo maximal safe resection (biopsy alone is eligible) followed by chemoradiation consisting of concomitant TMZ daily and radiation therapy (RT) with minimal RT will be eligible for this trial. Four to six weeks after finishing chemoradiation, patients will start monthly cycles of adjuvant TMZ. Treatment with Optune will start at approximately the same time as the first cycle of adjuvant TMZ and continue until second disease progression or a maximum of 2 years. Within one week after starting Cycle 2 of adjuvant TMZ and Optune therapy, patients will begin open-label treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first. |
| Historical Control | OTHER | Historical control of patients treated with Optune System combined with Temozolomide alone from the EF-14 study will be compared with the Optune System combined with Temozolomide (TMZ) + pembrolizumab |
| Name | Type | Description |
|---|---|---|
| Optune® device | DEVICE | Optune® device delivering TTFields therapy at 200 kHz. |
| Temozolomide | DRUG | Temozolomide per approved labeling. |
| Pembrolizumab | DRUG | Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles. |
| Placebo | DRUG | Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles. |
| Temozolomide (TMZ) | DRUG | Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity. |
| Optune System | DEVICE | Patients will undergo 24-months of planned treatment with Optune therapy. |
Inclusion Criteria: 1. The participant (or legally acceptable representative) has provided documented informed consent for the study. 2. Be ≥ 18 years of age on day of providing informed consent. 3. Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classificati...