TTField in Combination With TMZ and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma.

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06353360
• Other study ID #: HL-06
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 5, 2024
• Est. completion date: March 9, 2026

Study information

• Verified date: March 2024
• Source: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 9, 2026
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. After brain surgery (patients with total resection, partial resection and biopsy were acceptable), the pathological examination confirmed glioblastoma with IDH wild-type according to the 2021 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. 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+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-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. NCCI-CTCAE4 grade non-hematologic toxicity (except alopecia, nausea and vomiting)

4. Significant liver function impairment -AST or 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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Device:
• Tumor Treating Fields
Tumor Treating Fields will be administered continuously with a planned = 18 h per day, starting on the C1D1, throughout the entire course of treatment.

Drug:
• Tislelizumab
Tislelizumab will be given 300 mg intravenously every 4 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. The Tislelizumab treatment should be continued until confirmed PD, unacceptable toxicity, or finished Tislelizumab treatment for other reasons.
• Temozolomide (TMZ)
The patients will carry out 6 cycles of TMZ adjuvant chemotherapy according to the instructions. The dosage of TMZ is 150-200 mg/(m2·d), daily for 5 days followed by 23 days without treatment, the treatment cycle is 28 days. The initial dose of cycle 1 is 150 mg/(m2·d), if patients do not experience TMZ chemotherapy toxicity, the dose should be increased to 200 mg/(m2·d) in subsequent treatment cycles. After 6 cycles of TMZ adjuvant chemotherapy, if the patients do not experience disease progression, it is recommended to continue TMZ adjuvant chemotherapy, or treated according to investigators' recommendations. The TMZ treatment should be continued until confirmed PD, unacceptable toxicity, or finished TMZ treatment for other reasons.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	PFS is defined as the time from the start of treatment until disease progression or death due to any cause, whichever occurs first	Up to 18 months
Secondary	Number of participants with adverse events (AEs)	Adverse events will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments	Up to 18 months
Secondary	Objective response rate (ORR)	ORR is defined as the number (%) of patients with at least 1 visit response of CR or PR.	Up to 18 months
Secondary	Disease control rate (DCR)	DCR is defined as the rate of best objective response of CR, PR, or SD	Up to 18 months
Secondary	Overall Survival (OS)	OS is defined as the time from the date of treatment until death due to any cause	Up to 18 months
Secondary	PFS rate at 6 months	The analysis will be estimated proportions of patients who are progression-free at 6 months following the time of enrollment	Up to 6 months
Secondary	PFS rate at 1 year	The analysis will be estimated proportions of patients who are progression-free at 1 year following the time of enrollment	Up to12 months
Secondary	OS rate at 1-year	The analysis will be estimated proportions of patients who are survival at 1 year following the time of enrollment	Up to12 months