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

Sponsor
Henan Provincial People's Hospital
Study ID
NCT05540275
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Sep 14, 2022
Start date
Oct 5, 2023
Status verified
Oct 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Patients with bevacizumab-refractory recurrent glioma with PTEN or TERT gene mutations,determined according to the dynamics of TISF (Tumor in Situ Fluid) ctDNA.
  • Experimental: Cohort 2
    Patients with bevacizumab-refractory recurrent glioma without PTEN or TERT gene mutations,determined according to the dynamics of TISF (Tumor in Situ Fluid) ctDNA.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 2 years after beginning treatment ]

Central Contacts

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