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Angiogenesis Inhibitor

Nivolumab + Radiation + Bevacizumab for Glioblastoma

Phase 2
Waitlist Available
Led By Christian Grommes, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior treatment with radiation and temozolomide chemotherapy
Adequate bone marrow function
Must not have
Unstable angina, myocardial infarction within past 12 months
Circumscribed enhancing tumor >5.0 cm in largest diameter (T1 post contrast)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if adding nivolumab to radiation therapy and bevacizumab improves treatment for recurrent glioblastoma.

Who is the study for?
Adults with confirmed grade IV glioblastoma, IDH wildtype, MGMT hypermethylation, who've had surgery and chemo with temozolomide followed by radiation. They must show signs of recurrence but have a relatively small tumor (≤5cm), good performance status, and normal organ function. Excluded are those with multiple recurrences, certain heart conditions or infections, active autoimmune diseases requiring recent treatment, pregnancy/breastfeeding intentions within trial period, MRI incompatibility or prior treatments conflicting with the study drugs.
What is being tested?
The trial tests if adding nivolumab to standard re-irradiation therapy and bevacizumab improves outcomes for recurrent glioblastoma patients. It's exploring whether this combination can better control tumor growth compared to current methods.
What are the potential side effects?
Nivolumab may cause immune-related issues like inflammation in organs; bevacizumab might lead to bleeding or blood clots. Both can result in fatigue and infusion reactions among other side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with radiation and temozolomide.
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My bone marrow is working well.
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I am mostly able to care for myself and carry out daily activities.
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I am 18 years old or older.
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My tumor is 5 cm or smaller and shows up on contrast imaging.
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My tumor biopsy shows MGMT hypermethylation.
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My glioblastoma is grade IV and IDH wildtype.
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I have had the largest possible surgery to remove my tumor.
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I have had one round of radiation therapy before.
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My cancer has come back, as shown by tests or scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a heart attack or unstable chest pain in the last year.
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My tumor is larger than 5 cm and shows up on contrast imaging.
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I have a wound, ulcer, or bone fracture that hasn’t healed.
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I have been treated with bevacizumab before.
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I have a history of lung inflammation not caused by an infection.
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I haven't had a peptic ulcer, abdominal issues like fistula, perforation, or abscess in the last 6 months.
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I have moderate to severe heart failure.
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My high blood pressure is not controlled by medication.
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My cancer recurrence is located below the tentorium in my brain.
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I am not allergic to nivolumab, bevacizumab, or their ingredients.
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I have an active tuberculosis infection.
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My brain tumor has an IDH mutation.
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I have been treated with immune checkpoint inhibitors.
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I am currently on medication for an infection.
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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
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I need high doses of steroids daily to manage my condition.
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My cancer has returned more than once after initial treatment.
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I have been diagnosed with an immunodeficiency condition, such as HIV or AIDS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival
Secondary study objectives
Objective response rate

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Recurrent Glioblastoma, SurgeryExperimental Treatment4 Interventions
The second cohort is for patients with recurrent GBM who are undergoing surgery as part of their treatment.
Group II: Recurrent Glioblastoma, No SurgeryExperimental Treatment3 Interventions
One cohort is for patients with recurrent GBM who are not undergoing surgical debulking as part of their treatment plan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Bevacizumab
2013
Completed Phase 4
~5540

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,970 Previous Clinical Trials
597,347 Total Patients Enrolled
16 Trials studying Glioblastoma
1,246 Patients Enrolled for Glioblastoma
Christian Grommes, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
203 Total Patients Enrolled

Media Library

Bevacizumab (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03743662 — Phase 2
Glioblastoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03743662 — Phase 2
Glioblastoma Research Study Groups: Recurrent Glioblastoma, No Surgery, Recurrent Glioblastoma, Surgery
Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03743662 — Phase 2
~5 spots leftby Nov 2025
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