Clinical trial NCT06353360: TTField in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma.
Official title: Tumor-Treating Fields (TTFields) in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma: A Safety and Efficacy Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Lead sponsor: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is To investigate the safety and efficacy of Tumor-Treating Fields (TTFields) in combined with temozolomide (TMZ) and tislelizumab in the treatment of newly diagnosed glioblastoma (GBM).


Eligibility criteria: Inclusion Criteria:

1. After brain surgery (patients with total resection, partial resection and biopsy were acceptable), the pathological examination confirmed glioblastoma with isocitrate dehydrogenase (IDH) wild-type according to the 2021 World Health Organization (WHO) classification of tumors of the central nervous system.
2. The age of the subjects was ≥18 years old;
3. Supratentorial tumors;
4. Patients who had undergone maximal surgical resection (biopsy) and completed TMZ concurrent chemoradiotherapy were planned for adjuvant TMZ treatment.
5. Karnofsky performance status (KPS) score ≥70;
6. The predicted survival time was ≥3 months.
7. Voluntarily signed informed consent;
8. Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial.

Exclusion Criteria:

1. Early progression of GBM occurred after TMZ+radiation therapy (RT) treatment (except pseudoprogression, imaging examination should be supplemented to further exclude if necessary).
2. The subject had received any other cytotoxic or biologic antineoplastic therapy before enrollment;
3. Distant leptomeningeal metastasis;
4. Patients had a diagnosis of cancer other than glioblastoma and received antineoplastic therapy within 5 years before enrollment, excluding cured stage I prostate cancer, cervical or uterine cancer in situ, breast cancer in situ, and nonmelanoma skin cancer.
5. Previous treatment with anti-PD-1 antibody/anti-PD-L1 antibody and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody;
6. Participants who had received systemic immunosuppressive therapy (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, or antineoplastic factor agents) within 2 weeks before enrollment. Excluding nasal sprays and inhaled corticosteroids;
7. The presence of an active, known, or suspected autoimmune disease that was judged by the investigator to be unsuitable for this study. The following exclusions may be made: vitiligo, alopecia, Graves' disease, psoriasis, or eczema that did not require systemic treatment within the previous 2 years; Hypothyroidism (due to autoimmune thyroiditis) that is asymptomatic or requires only stable doses of hormone-replacement therapy or type I diabetes that requires only stable doses of insulin-replacement therapy, or childhood asthma that has resolved completely without intervention or recurrence in adulthood without an external trigger.
8. Participants had to meet certain criteria for bone marrow, liver and kidney function before enrollment, and were not eligible if they had any of the following:

   1. Thrombocytopenia (platelet count \< 100×103/μL)
   2. Neutropenia (absolute neutrophil count \< 1.5×103/μL)
   3. National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) 4 grade non-hematologic toxicity (except alopecia, nausea and vomiting)
   4. Significant liver function impairment -aspartate aminotransferase (AST) or alanine transaminase (ALT) exceeding 3 times the upper limit of normal
   5. Total bilirubin more than 1.5 times the upper limit of the normal range
   6. Severe renal impairment (serum creatinine \>1.7 mg/dL, or \>150 μmol/L).
9. The subject had an active implanted device (deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, pacemaker, cardiac defibrillator, etc.).
10. Infratentorial tumors;
11. Documented increased intracranial pressure (clinically manifested as severe papilledema, vomiting, nausea, or decreased consciousness);
12. There were infection, ulcer and unhealed wound in the skin where the electrode was applied.
13. A known history of allergy to TMZ or tislelizumab;
14. Skull defects or residual metal fragments in the skull (except titanium plates or nails used for skull surgery);
15. Patients allergic to conductive hydrogels or medical adhesives;
16. Those who are pregnant or preparing to become pregnant or who are breastfeeding;
17. Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 18 months
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 18 months
measure: Objective response rate (ORR)
timeFrame: Up to 18 months
measure: Disease control rate (DCR)
timeFrame: Up to 18 months
measure: Overall Survival (OS)
timeFrame: Up to 18 months
measure: PFS rate at 6 months
timeFrame: Up to 6 months
measure: PFS rate at 1 year
timeFrame: Up to12 months
measure: OS rate at 1-year
timeFrame: Up to12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
Study officials:
References: