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Tislelizumab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for Bevacizumab Refractory Recurrent Glioblastoma

Phase 2 Study to Evaluate the Clinical Efficacy and Safety of Tislelizumab Plus Low-dose Bevacizumab in Bevacizumab Refractory Recurrent Glioblastoma With PTEN or TERT Gene Mutations

NCT05540275•Henan Provincial People's Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent and HIPAA authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
•2. 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
•3. Histologically confirmed diagnosis of glioma
•4. 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
•5. An interval of \> 28 days and full recovery (i.e., no ongoing safety issues) from surgical resection prior to grouping
•6. Karnofsky performance status (KPS) of 70 or higher
•7. Life expectancy \> 12 weeks

Exclusion Criteria

•1. More than two recurrences of GBM
•2. Presence of extracranial metastatic, significant leptomeningeal disease or tumors primarily localized to the brainstem or spinal cord
•3. 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
•4. 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
•5. Previous radiation therapy with anything other than standard radiation therapy (i.e., focally directed radiation) administered as first line therapy
•6. Previous treatment with carmustine wafer except when administered as first line treatment and at least 6 months prior to randomization
•7. Previous bevacizumab or other VEGF or anti-angiogenic treatment
•8. Previous treatment with a PD-1, PD-L1 or CTLA-4 targeted therapy
•9. Evidence of \> Grade 1 CNS hemorrhage on the baseline MRI scan
•10. Inadequately controlled hypertension (defined as systolic blood pressure ≥160 mmHg and /or diastolic blood pressure ≥100 mmHg) within 7 days of first study treatment
+11 more criteria

Locations (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Key Dates

Start Date

October 5, 2023

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2026

Last Updated

October 6, 2023

Enrollment

ESTIMATED participants

Conditions

Recurrent Glioblastoma

Interventions

Tislelizumab plus Bevacizumab

DRUG

Contacts

Xingyao Bu, MD, PhD

CONTACT

+86037165580295 xingyaob@zzu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Tislelizumab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for Bevacizumab Refractory Recurrent Glioblastoma

Inclusion Criteria

Exclusion Criteria

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