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Recurrent GlioblastomaPhase 2NCT04952571

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

A Phase 2 study testing Camrelizumab and Bevacizumab in people with Recurrent Glioblastoma, run by Beijing Sanbo Brain Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Recurrent Glioblastoma
What is being tested?
Camrelizumab and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteChina
Study dates
27 Jun 2021to 31 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBVDNA≥500IU/ mL), hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit of the assay method) or co-infection with hepatitis B and hepatitis C.
  • Patients who received anti-tumor vaccine or other immunomodulatory drugs within 4 weeks before enrolment;Patients who have received or will receive live attenuated or recombinant vaccine within 4 weeks;Patients who received or will receive the inactivated vaccine within 1 week.
  • Pregnancy and lactation.
  • Other conditions that the investigator considered inappropriate for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Sanbo Brain Hospital

    Beijing

Other trials in China

About this study

Official title: An Exploratory Study on Camrelizumab Combined with Bevacizumab for Adult Patients with Recurrent Glioblastoma (GBM)

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

Read the detailed description

There is no effective chemotherapy regimen for recurrent glioblastoma. The antiangiogenic drug bevacizumab has high objective response rate and rapid onset, but the duration of efficacy needs to be improved.The objective response rate of PD-1 monoclonal antibody immunotherapy is low and the onset of the effect is slow, but the effective patients have a long duration of efficacy.The combined treatment of PD-1 monoclonal antibody and bevacizumab may learn from each other to improve the effective rate, shorten the onset time and prolong the duration of efficacy.Studies have shown that bevacizumab can enhance the efficacy of immunotherapy in a variety of cancers, including melanoma, kidney cancer, non-small cell lung cancer, and liver cancer.However, previous studies have shown limited efficacy of PD-1 monoclonal antibody combined with bevacizumab in the treatment of recurrent glioblastoma.

In this study, the combination therapy was optimized by introducing induction phase therapy, which is expected to further improve the efficacy. In our previous exploratory treatment of patients with severe recurrent glioblastoma after multiple treatments, the initial efficacy was considerable.

The purpose of this study is to evaluate the efficacy and safety of camrelizumab [a programmed cell death 1 (PD-1) inhibitor] combined with bevacizumab for adult patients with recurrent glioblastoma.

Being tested
Camrelizumab and Bevacizumab
Keywords
Recurrent Glioblastoma, Immunotherapy, antiangiogenesis
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camrelizumab and BevacizumabDrug

    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.

Study groups in NCT04952571
Study groupRoleWhat they receive
GBM at first relapseExperimentalNot described
Receives: Drug: Camrelizumab and Bevacizumab
GBM at second relapseExperimentalNot described
Receives: Drug: Camrelizumab and Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival rate at 6 months

    Progression-free survival rate at 6 months

    Measured: Up to three years

Secondary outcomes (9)

  1. OS(overall survival)

    the time interval from entry to death from any cause or last follow-up and is measured in the intent-to-treat population

    Measured: Up to three years

  2. PFS(progression free survival)

    the time interval from entry to tumor progression, death from any cause, or last follow-up

    Measured: Up to three years

  3. ORR(objective response rate)

    rate of CR+PR

    Measured: Up to three years

  4. DCR（Disease Control Rate）

    rate of CR+PR+SD

    Measured: Up to three years

  5. The correlation between KPS change and efficacy

    the correlation between KPS baseline, KPS change (increase, decrease,stable) and best efficacy (CR, PR, SD, PD).

    Measured: Up to three years

  6. Median duration of KPS ≥ 70

    Median duration of KPS ≥ 70 during progression-free survival

    Measured: Up to three years

  7. Frequency and severity of treatment-related adverse events

    Frequency and severity of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: Up to three years

  8. Median duration of stable/improved quality of life assessed by EORTC QLQ-C30

    the time interval from entry to change of ≥10 points on the EORTC QLQ-C30 without further improvement or disease progression or death.

    Measured: Up to three years

  9. Median duration of stable/improved quality of life assessed by EORTC QLQ-BN20

    the time interval from entry to change of ≥10 points on the EORTC QLQ-BN20 without further improvement or disease progression or death.

    Measured: Up to three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2021
  2. Study start27 Jun 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Why it stopped: Lack of funds

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
glioblastoma at first relapse, glioblastoma at second relapse
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04952571
Sponsor's protocol ID
OBU-BJ-GBM-II-007
Status last verified
Oct 2024
First submitted
23 Jun 2021
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab and Bevacizumab in people with Recurrent Glioblastoma, run by Beijing Sanbo Brain Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of funds). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival rate at 6 months (time frame: Up to three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04952571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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