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

Zhujiang Hospital1 site in 1 country30 target enrollmentMay 1, 2023

ConditionsRecurrent Glioblastoma

InterventionsSintilimab plus Bevacizumab and Temozolomide

DrugsSintilimab plus Bevacizumab and Temozolomide

Overview

Phase: Phase 2
Intervention: Sintilimab plus Bevacizumab and Temozolomide
Conditions: Recurrent Glioblastoma
Sponsor: Zhujiang Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: Progression free survival rate at 6 months
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

This is a phase 2,open-label, multicenter, single-arm study designed to evaluate the efficacy and safety of Sintilimab in combination with Bevacizumab and Temozolomide in subjects with recurrent glioblastoma. A total of 30 patients will be enrolled in the study and administered Sintilimab in combination with Bevacizumab and Temozolomide. The study treatment will be continued for up to 4 cycles and Sintilimab was maintained until a progression of disease or unacceptable toxicity is confirmed.

Registry

clinicaltrials.gov

Start Date

May 1, 2023

End Date

December 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhujiang Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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;

Arms & Interventions

Sintilimab and Bevacizumab and Temozolomide

single arm study

Intervention: Sintilimab plus Bevacizumab and Temozolomide

Outcomes

Primary Outcomes

Progression free survival rate at 6 months

Time Frame: Up to two years

Progression free survival by iRANO criteria

Secondary Outcomes

Overall survival(Up to two years)
Objective response rate(Up to two years)
Disease control rate(Up to two years)
Progression free survival(Up to two years)
Median duration of stable/improved quality of life assessed by EORTC QLQ-C30(Up to two years)
Median duration of Karnofsky Performance Status(KPS) ≥ 70(Up to two years)
Absolute counts and ratios of immune cell subtypes(Day 1 and Day 29 of each cycle)
Frequency and severity of treatment-related adverse events(Up to two years)