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

NCT06353360 | Recruiting Phase 2

• 1 other identifier: HL-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of participants with adverse events (AEs)

  Up to 18 months

• Objective response rate (ORR)

  Up to 18 months

• Disease control rate (DCR)

  Up to 18 months

• Overall Survival (OS)

  Up to 18 months

• PFS rate at 6 months

  Up to 6 months

Study Arms (1)

Tumor Treating Fields + Temozolomide + Tislelizumab

EXPERIMENTAL

Device: Tumor Treating Fields; Drug: Tislelizumab; Drug: Temozolomide (TMZ)

Interventions

Tumor Treating Fields DEVICE

Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day, starting on the Day 1 of cycle 1 (C1D1), throughout the entire course of treatment.

Tumor Treating Fields + Temozolomide + Tislelizumab

Tislelizumab DRUG

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.

Tumor Treating Fields + Temozolomide + Tislelizumab

Temozolomide (TMZ) DRUG

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 progressive disease (PD), unacceptable toxicity, or finished TMZ treatment for other reasons.

Tumor Treating Fields + Temozolomide + Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The age of the subjects was ≥18 years old;
• Supratentorial tumors;
• Patients who had undergone maximal surgical resection (biopsy) and completed TMZ concurrent chemoradiotherapy were planned for adjuvant TMZ treatment.
• Karnofsky performance status (KPS) score ≥70;
• The predicted survival time was ≥3 months.
• Voluntarily signed informed consent;
• Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial.

You may not qualify if:

• Early progression of GBM occurred after TMZ+radiation therapy (RT) treatment (except pseudoprogression, imaging examination should be supplemented to further exclude if necessary).
• The subject had received any other cytotoxic or biologic antineoplastic therapy before enrollment;
• Distant leptomeningeal metastasis;
• 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.
• Previous treatment with anti-PD-1 antibody/anti-PD-L1 antibody and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody;
• 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;
• 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:
• Thrombocytopenia (platelet count \< 100×103/μL)
• Neutropenia (absolute neutrophil count \< 1.5×103/μL)
• National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) 4 grade non-hematologic toxicity (except alopecia, nausea and vomiting)
• Significant liver function impairment -aspartate aminotransferase (AST) or alanine transaminase (ALT) exceeding 3 times the upper limit of normal
• Total bilirubin more than 1.5 times the upper limit of the normal range
• Severe renal impairment (serum creatinine \>1.7 mg/dL, or \>150 μmol/L).
• The subject had an active implanted device (deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, pacemaker, cardiac defibrillator, etc.).
• Infratentorial tumors;

Sponsors & Collaborators

• Jiangsu Healthy Life Innovation Medical Technology Co., Ltd: lead

Study Sites (1)

Huashan Hospital affiliated to Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

tislelizumab; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 9, 2024
• Study Start: April 30, 2024
• Primary Completion: July 15, 2025
• Study Completion: March 9, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-03

Locations

CN (1)