Combined Treatment of Camrelizumab and Bevacizumab for Adult Patients with Recurrent Glioblastoma (GBM)

NCT04952571 | Terminated Phase 2

• 1 other identifier: OBU-BJ-GBM-II-007
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intend to explore the efficacy and safety of combined treatment of camrelizumab and bevacizumab in adult patients with recurrent glioblastoma.

Conditions

Recurrent Glioblastoma

Keywords

Recurrent Glioblastoma; Immunotherapy; antiangiogenesis

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate at 6 months

  Progression-free survival rate at 6 months

  Up to three years

Secondary Outcomes (9)

• OS(overall survival)

  Up to three years

• PFS(progression free survival)

  Up to three years

• ORR(objective response rate)

  Up to three years

• DCR（Disease Control Rate）

  Up to three years

• The correlation between KPS change and efficacy

  Up to three years

Study Arms (2)

GBM at first relapse

EXPERIMENTAL

Drug: Camrelizumab and Bevacizumab

GBM at second relapse

EXPERIMENTAL

Drug: Camrelizumab and Bevacizumab

Interventions

Camrelizumab and Bevacizumab DRUG

Stage 1: Targeted therapy induction phase: bevacizumab 5mg/kg, intravenous infusion, once every two weeks, 2 cycles in total. Phase 2: Targeted combined immunotherapy: once every three weeks with the following drugs: (1) bevacizumab 7.5mg/kg intravenously;(2) Carrelizumab: 200mg/ time, intravenous infusion.

GBM at first relapse; GBM at second relapse

Eligibility Criteria

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

You may qualify if:

• Age 18\~70, male or female
• Primary supratentorial glioblastoma with first or second rogression/recurrence
• IDH1/2 wildtype
• KPS score ≥70 in patients with the first recurrence and ≥60 in patients with the second recurrence
• Expected survival ≥12 weeks.
• The time interval from the last radiotherapy was ≥12 weeks, unless there was new tumor enhancement in the radiological field or clear evidence of tumor hipathology.
• Radiotherapy and at least one regimen of chemotherapy before recurrence (excluding temozolomide chemotherapy during concurrent radiotherapy).
• The patients were enrolled after the end of the previous chemotherapy interval and had recovered from the related adverse reactions (except hair loss and pigmentation).
• The tumor was confirmed to have definite recurrence by MRI, with enhanced lesion diameter ≥1cm and ≥2 layers (layer spacing 5mm), or was confirmed to have recurrence by pathology after re-biopsy or surgery.
• The time interval between the last operation and the last biopsy was ≥4 weeks or ≥2 weeks at the time of enrollment.
• The main organs function normally, no serious abnormal blood, heart, lung, liver, kidney function and immune deficiency diseases
• Women of childbearing age are required to have a negative pregnancy test (serum or urine) within 7 days before enrolment and to voluntarily use contraception during treatment and within 8 weeks after the last treatment;For men, they should be surgically sterilized or agree to use contraception during treatment and for 8 weeks after the last treatment.
• Patients voluntarily enrolled in this study and signed informed consent (ICF).
• Good compliance is expected, efficacy and adverse reactions can be followed up according to protocol requirements

You may not qualify if:

• Glioblastoma in the midline (thalamus, brainstem, sellar region, etc.).
• Patients with initial recurrence had previously received long-term high-dose antiangiogenic drugs (except those with amlotinib or apatinib for less than 1 month and no progress during treatment, except those with intermittent bev dose intensity ≤5mg/ week and ≤3 times) or immunocheckpoint inhibitors, TCR-T, CAR-T, etc.;Patients with secondary recurrence had previously received long-term high-dose therapy of Bev (except for intermittent Bev dose intensity ≤5mg/ week and ≤3 times) or immunocheckpoint inhibitors, TCR-T, or CAR-T.
• Other study drugs are being used.
• An allergic reaction or intolerance to any component of the drug used in this study is known.
• Other malignant tumors in the past 3 years.
• Subjects who had been systematically treated with corticosteroids (\>4mg/day dexamethasone or other equivalent hormone) or other immunosuppressants within 2 weeks prior to first use of carrelizumab.In the absence of active autoimmune disease, inhaled or topical corticosteroids and hormone replacement therapy with doses less than or equal to 4mg/ day of dexamethasone are permitted.
• The presence or history of any active autoimmune disease .
• Uncontrolled hypertension.
• Myocardial infarction occurred within 6 months prior to enrollment, New York Heart Society Class II heart failure or above, uncontrolled angina pectoris, uncontrolled severe arrhythmias, clinically significant pericardial disease, and electrocardiogram indicating acute ischemia or abnormal active conduction system.
• Abnormal coagulation function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.
• Before entering the study 3 months there have been significant clinical significance of bleeding symptoms or have definite bleeding tendency;Or arterial/venous thrombosis events, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism, occurred within 6 months before the study.
• Severe infection occurred within 4 weeks prior to initial administration;Or unexplained fever \>38.5℃ during screening/prior to first administration.
• People who have a history of abuse of psychotropic substances and are unable to get rid of them or have mental disorders.
• Had major surgery or had an open wound or fracture within 4 weeks prior to first administration.
• Empty sinus passages or perforations were observed within 6 months prior to study entry.

Sponsors & Collaborators

• Beijing Sanbo Brain Hospital: lead

Study Sites (1)

Beijing Sanbo Brain Hospital

Beijing, China

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

camrelizumab; Bevacizumab

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing Sanbo Brain Hospital

Model Details: glioblastoma at first relapse, glioblastoma at second relapse

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 7, 2021
• Study Start: June 27, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)