Tislelizumab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for Bevacizumab Refractory Recurr… (NCT05540275) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Tislelizumab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for Bevacizumab Refractory Recurrent Glioblastoma
China30 participantsStarted 2023-10-05
Plain-language summary
The purpose of this study is to evaluate the clinical efficacy and safety of Tislelizumab (one anti-PD-1 antibody same as nivolumab approved in China) in combination with bevacizumab in patients with recurrent or progressive glioblastoma (GBM) who have progressed on bevacizumab with or without PTEN or TERT gene mutations.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent and HIPAA authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
✓. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of thestudy, including disease assessment by MRI and tumor in situ fluid (TISF) collection
✓. Histologically confirmed diagnosis of glioma
✓. Resection surgery done at the study center (Henan Provincial People'sHospital), with an reservoir intraoperatively implanted connecting the surgical cavity and the subscalp for postoperative noninvasive TISF collection
✓. An interval of \> 28 days and full recovery (i.e., no ongoing safety issues) from surgical resection prior to grouping
✓. Karnofsky performance status (KPS) of 70 or higher
✓. Life expectancy \> 12 weeks
Exclusion criteria
✕. More than two recurrences of GBM
✕. Presence of extracranial metastatic, significant leptomeningeal disease or tumors primarily localized to the brainstem or spinal cord
✕. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
What they're measuring
1
Overall response rate
Timeframe: Up to 2 years after beginning treatment
2
Duration of response
Timeframe: Up to 2 years after beginning treatment
3
Number of participants with treatment-emergent adverse events
✕. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring chronic and systemic immunosuppressive treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Subjects have any other condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days. Inhaled or topical steroids and adrenal replacement doses \>10mg daily prednisone equivalent are permitted in absence of active autoimmune disease
✕. Previous radiation therapy with anything other than standard radiation therapy (i.e., focally directed radiation) administered as first line therapy
✕. Previous treatment with carmustine wafer except when administered as first line treatment and at least 6 months prior to randomization
✕. Previous bevacizumab or other VEGF or anti-angiogenic treatment
✕. Previous treatment with a PD-1, PD-L1 or CTLA-4 targeted therapy