Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients

NCT05638451 | Unknown Phase 2 DMC

• 1 other identifier: Junde Zhang
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate at 6 months

  Progression free survival by iRANO criteria

  Up to two years

Secondary Outcomes (8)

• Progression free survival

  Up to two years

• Overall survival

  Up to two years

• Objective response rate

  Up to two years

• Disease control rate

  Up to two years

• Median duration of Karnofsky Performance Status(KPS) ≥ 70

  Up to two years

Study Arms (1)

Sintilimab and Bevacizumab and Temozolomide

EXPERIMENTAL

single arm study

Drug: Sintilimab plus Bevacizumab and Temozolomide

Interventions

Sintilimab plus Bevacizumab and Temozolomide DRUG

200mg Sintilimab plus 10mg/kg Bevacizumab very 3 weeks 200 mg/m2/day Temozolomide on days 1-5 out of a 28 days schedule

Sintilimab and Bevacizumab and Temozolomide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Molecular pathological diagnosis was high-grade glioma (2016 World Health Organization (WHO） Grade Ⅲ or Ⅳ);
• Age 18 - 70 years old, Karnofsky performance status （KPS） score ≥ 70, and the expected survival period is more than 3 months;
• Primary supratentorial glioblastoma with first or second recurrence
• Imaging confirmed recurrence (according to RANO criteria);
• The time of the first medication after enrollment should be more than 4 weeks away from the surgery or the last radiotherapy;
• Confirmed progression time is ≥4 weeks from the last drug treatment (including adjuvant temozolomide chemotherapy after the completion of concurrent chemoradiotherapy);
• 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;
• Major organ function within 7 days prior to treatment, meeting the following criteria:
• (1) Routine blood test standards (without blood transfusion within 14 days):
• Hemoglobin (HB) ≥90 g/L;
• Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L;
• Platelet (PLT) ≥ 90×10\^9/L; (2) Biochemical examination shall meet the following standards:
• Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 ULN, if with liver metastasis, ALT and AST ≤ 5ULN;
• 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.

You may not qualify if:

• Prior treatment with immunotherapy;
• 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;
• Baseline MRI indicates the risk of cerebral hemorrhage or hernia in the past or recent;
• Pulmonary embolism or deep vein thrombosis within 2 months
• Unstable angina pectoris, myocardial infarction within past 12 months. Grade 2 or greater congestive heart failure
• Peptic ulcer, abdominal fistula, gastrointestinal perforation, or abdominal abscess within past 6 months
• Patients with any physical signs or history of bleeding, regardless of severity;
• Uncontrollable high blood pressure
• Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis;
• Renal failure requires hemodialysis or peritoneal dialysis;
• Known history of active infectious pneumonia and active tuberculosis.
• Requiring escalating or chronic supraphysiologic doses of corticosteroids (\> 4 mg dexamethasone daily) for control of disease
• Allergic reaction to bevacizumab or any of its excipients
• Diagnosis of immunodeficiency, including human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

southern medical university affiliated Zhujiang Hospital

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

sintilimab; Bevacizumab; 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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Junde Zhang, MD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junde Zhang, MD

CONTACT

13002087575; 13002087575@163.com

Yujing Tan, PHD

CONTACT

13560347303; tanyujing-1981@163.com

Study Design

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

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 6, 2022
• Study Start: May 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 5, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)