22 and older, any sex, with Glioblastoma or Cancer of Brain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of Treatment-Related Adverse Events Associated With Trimodal TherapyPrimary· 15 Weeks (8 weeks after completion of trimodal therapy)
Number of patients who experienced a treatment-related adverse event
Group
Value
95% CI
Safety lead-in Cohort
2
Severity of Treatment-Related Adverse Events Associated With Trimodal TherapyPrimary· 15 weeks (8 weeks after completion of trimodal therapy)
Number of patients who experienced a treatment-related serious adverse event based on the NCI Common Terminology Criteria for Adverse Events (version 4.03)
Group
Value
95% CI
Safety lead-in Cohort
2
Overall Survival RateSecondary· Day 106
Number of patients alive at Day 106 (15 weeks), end of main study period
Group
Value
95% CI
Safety lead-in Cohort
5
Safety lead-in Cohort
2
Progression-free Survival at 6 Months and 24 MonthsSecondary· 6 months and 24 months
Number of patients who are progression free at 6 months and 24 months. Progression is defined as any of the following: greater than or equal to 25% increase in sum of lesions compared with smallest tumor measurement obtained, significant increase in T2/FLAIR non-enhancing lesions, any new lesion, clear clinical deterioration not attributable to other causes, or clear progression of non-measureable disease.
Group
Value
95% CI
Safety lead-in Cohort
3
Safety lead-in Cohort
NA
Adverse events — posted to ClinicalTrials.gov
Time frame: 15 weeks (8 weeks after completion of trimodal therapy).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Safety lead-in Cohort
Serious: 3/7 (43%)
Deaths: 1/7
Serious adverse events (2 terms)
Reaction
System
Safety lead-in Cohort
Decreased lymphocytopenia
Investigations
—
Thrombocytopenia - worsened
Blood and lymphatic system disorders
—
Other adverse events (84 terms — click to expand)
Reaction
System
Safety lead-in Cohort
Nausea
Gastrointestinal disorders
—
Anemia
Blood and lymphatic system disorders
—
Constipation
Gastrointestinal disorders
—
Generalized fatigue
General disorders
—
Fatigue
General disorders
—
Dysphasia
Nervous system disorders
—
Insomnia
Psychiatric disorders
—
Erythema
Skin and subcutaneous tissue disorders
—
Erythema scalp - diffuse
Skin and subcutaneous tissue disorders
—
Skin Ulceration
Skin and subcutaneous tissue disorders
—
Anemia (decreased hemoglobin)
Blood and lymphatic system disorders
—
Pain in lymph node, right cervical region
Blood and lymphatic system disorders
—
Enlarged lymph node right cervical region
Blood and lymphatic system disorders
—
Thrombocytopenia
Blood and lymphatic system disorders
—
Thrombocytopenia - worsened
Blood and lymphatic system disorders
—
Eye strain - right eye
Eye disorders
—
Right Field Cut
Eye disorders
—
Mild constipation
Gastrointestinal disorders
—
Nausea - worsened from baseline
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Fatigue in evenings
General disorders
—
Impaired tandem gait
General disorders
—
Allergic reaction due to OPTUNE - rash - diffuse
Immune system disorders
—
Allergic reaction - rash, diffuse unknown origin
Immune system disorders
—
Itching due to allergic reaction - diffuse, unknown origin
The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06611345 — A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
· NA
· recruiting
NCT06353360 — TTField in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma.
· Phase 2
· unknown
NCT06390059 — EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-Li
· Phase 2
· active not recruiting
NCT03223103 — Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
· Phase 1
· active not recruiting
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· recruiting
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NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
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· recruiting
Other Providence Health & Services trials
Trials by the same sponsor.
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· recruiting
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· withdrawn
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· Phase 1
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NCT04417699 — SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Providence Health & Services
Last refreshed: 4 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03705351.