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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been treated with radiation and temozolomide.
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My bone marrow is working well.
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
I am 18 years old or older.
Select...
My tumor is 5 cm or smaller and shows up on contrast imaging.
Select...
My tumor biopsy shows MGMT hypermethylation.
Select...
My glioblastoma is grade IV and IDH wildtype.
Select...
I have had the largest possible surgery to remove my tumor.
Select...
I have had one round of radiation therapy before.
Select...
My cancer has come back, as shown by tests or scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
6 month progression-free survival
Median progression-free survival
Objective response rate
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Hypertension
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
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
2014
Completed Phase 3
~4750
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,581 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with radiation and temozolomide.My liver is working well.I have had a blood clot in my lung or leg in the last 2 months.My bone marrow is working well.I have not had a heart attack or unstable chest pain in the last year.I am mostly able to care for myself and carry out daily activities.I am 18 years old or older.My tumor is 5 cm or smaller and shows up on contrast imaging.I had brain radiation less than 4 months ago.My kidney function is normal.My tumor is larger than 5 cm and shows up on contrast imaging.I have a wound, ulcer, or bone fracture that hasn’t healed.My tumor biopsy shows MGMT hypermethylation.My glioblastoma is grade IV and IDH wildtype.I have been treated with bevacizumab before.I have a history of lung inflammation not caused by an infection.I haven't had a peptic ulcer, abdominal issues like fistula, perforation, or abscess in the last 6 months.I have moderate to severe heart failure.My high blood pressure is not controlled by medication.My cancer recurrence is located below the tentorium in my brain.I am not allergic to nivolumab, bevacizumab, or their ingredients.I have an active tuberculosis infection.I have had the largest possible surgery to remove my tumor.I have had one round of radiation therapy before.My brain tumor has an IDH mutation.I have another cancer, but it's either not growing or doesn't need treatment, except for certain skin cancers or cervical cancer that's been treated.I have been treated with immune checkpoint inhibitors.I am currently on medication for an infection.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I need high doses of steroids daily to manage my condition.My cancer has come back, as shown by tests or scans.My cancer has returned more than once after initial treatment.I have been diagnosed with an immunodeficiency condition, such as HIV or AIDS.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Recurrent Glioblastoma, No Surgery
- Group 2: Recurrent Glioblastoma, Surgery
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a risk of adverse effects when using Nivolumab?
"With Phase 2 clinical trials having yielded some data indicating the safety of Nivolumab, our team at Power rated it a 2 on its scale. However, there is yet to be any data that supports its efficacy in this context."
Answered by AI
Can you provide a comprehensive count of the facilities engaged in this investigation within city limits?
"This medical study is being conducted at 14 different sites, such as Lehigh Valley Health Network (Data Collection Only) in Allentown and Memorial Sloan Kettering Cancer Center/Memorial Sloan Kettering Bergen in Montvale."
Answered by AI
Is there still room for enrolment into this research project?
"This clinical trial, which was initially made available on November 12th 2018 and last updated July 26 2022 is no longer recruiting patients. Nevertheless, there are currently 1,502 other studies that accept participants."
Answered by AI
What is the current enrollment rate for this investigation?
"Currently, this particular trial is not recruiting. It was first posted on November 12th 2018 and edited lastly on July 26th 2022. If you are looking for other medical studies to participate in, there are 442 trials related to glioblastoma actively seeking participants and 1060 clinical experiments using nivolumab that need volunteers."
Answered by AI
Are there any further investigations into the efficacy of Nivolumab?
"Currently, 1060 clinical trials are actively exploring Nivolumab's potential with 167 of these studies situated in Phase 3. While a significant number of tests for this drug can be found in Taibei, Taiwan; globally 56663 medical centres have registered to conduct research on it."
Answered by AI
How is Nivolumab typically employed to treat patients?
"Nivolumab has demonstrated effectiveness in treating unresectable melanoma, squamous cell carcinoma, and locally advanced non-small cell lung cancer."
Answered by AI
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