Phase 2 Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients

Trial ID: NCT05638451

Interventional - Phase 2 - Unknown status

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Bevacizumab and Temozolomide in subjects with recurrent glioblastoma.

Conditions

• Recurrent Glioblastoma

Interventions

• Sintilimab plus Bevacizumab and Temozolomide

Eligibility

Inclusion criteria

• Molecular pathological diagnosis was high-grade glioma (2016 World Health Organization (WHO） Grade Ⅲ or Ⅳ);
• 2. Age 18
• 70 years old, Karnofsky performance status （KPS） score ≥ 70, and the expected survival period is more than 3 months;
• 3. Primary supratentorial glioblastoma with first or second recurrence
• 4. Imaging confirmed recurrence (according to RANO criteria);
• 5. The time of the first medication after enrollment should be more than 4 weeks away from the surgery or the last radiotherapy;
• 6. Confirmed progression time is ≥4 weeks from the last drug treatment (including adjuvant temozolomide chemotherapy after the completion of concurrent chemoradiotherapy);
• 7. If the patient is on hormone therapy, the hormone dose must be stable or reduced for at least 7 days before the baseline MRI examination;
• 8. Major organ function within 7 days prior to treatment, meeting the following criteria:
• (1) Routine blood test standards (without blood transfusion within 14 days):
• 1. Hemoglobin (HB) ≥90 g/L;
• 2. Absolute neutrophil count (ANC) ≥ 1.5×10^9/L;
• 3. Platelet (PLT) ≥ 90×10^9/L; (2) Biochemical examination shall meet the following standards:
• 4. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
• 5. Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 ULN, if with liver metastasis, ALT and AST ≤ 5ULN;
• 6. Serum creatinine (Cr) ≤1.5 ULN and creatinine clearance rate (CCr) ≥ 60 ml/min; (3) Echocardiography: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%); (4) International normalized ratio (INR), partial thromboplastin time (APTT), prothrombin time (PT) ≤1.5 ULN; 9. Patients voluntarily joined the study and signed informed consent.

Exclusion criteria

• Prior treatment with immunotherapy;
• 2. Patients who have had or are currently suffering from other malignant tumors or solid organ or bone marrow transplantation within 5 years. Excludes cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors;
• 3. Baseline MRI indicates the risk of cerebral hemorrhage or hernia in the past or recent;
• 4. Pulmonary embolism or deep vein thrombosis within 2 months
• 5. Unstable angina pectoris, myocardial infarction within past 12 months. Grade 2 or greater congestive heart failure
• 6. Peptic ulcer, abdominal fistula, gastrointestinal perforation, or abdominal abscess within past 6 months
• 7. Patients with any physical signs or history of bleeding, regardless of severity;
• 8. Uncontrollable high blood pressure
• 9. Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis;
• 10. Renal failure requires hemodialysis or peritoneal dialysis;
• 11. Known history of active infectious pneumonia and active tuberculosis.
• 12. Requiring escalating or chronic supraphysiologic doses of corticosteroids (> 4 mg dexamethasone daily) for control of disease
• 13. Allergic reaction to bevacizumab or any of its excipients
• 14. Diagnosis of immunodeficiency, including human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
• 15. Active autoimmune disease requiring systemic treatment (i.e., disease modifiers, corticosteroids, or immunosuppressive drugs) within past 2 years. Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, etc.) is not considered a systemic form of therapy.
• 16. Pregnancy or breastfeeding, or pregnancy or birth during the expected test period, from the pre-screening or screening visit until 120 days after the last dose of test treatment.
• 17. Unable to undergo brain MRI (i.e., pacemaker or any other MRI contraindications).
• 18. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

Sponsor

Zhujiang Hospital

Source: Clinicaltrials.gov

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