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Checkpoint Inhibitor
Nivolumab + Ipilimumab with Surgery for Glioblastoma
New York, NY
Phase 1
Waitlist Available
Led By Patrick Y Wen, MD
Research Sponsored by Patrick Wen, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years on day of signing informed consent
Unequivocal evidence for tumor progression by MRI per RANO criteria
Must not have
Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
Gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE Grade > 3 within 6 months of registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Summary
This trial is studying the safety and effectiveness of nivolumab in combination with ipilimumab and surgery when used in the treatment of recurrent glioblastoma.
See full description
Who is the study for?
Adults (18+) with Grade IV IDH wildtype glioblastoma at first or second relapse, who are undergoing clinically indicated surgery. Participants must have a Karnofsky performance status ≥ 70, sufficient tissue from prior surgery for analysis, and no active infections or additional malignancies. They should not have received certain treatments like bevacizumab or systemic immunosuppressives recently and must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of nivolumab combined with ipilimumab alongside surgery in treating recurrent glioblastoma. A placebo group is included for comparison. An optional sub-study involves Zr-89 Crefmirlimab berdoxam.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs, infusion reactions similar to allergic responses, fatigue, increased risk of infections due to weakened immunity, and possibly other unforeseen complications related to the drugs' actions on the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My MRI shows my tumor is growing.
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I have received radiotherapy as my first treatment.
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My MRI shows my tumor is growing.
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Select...
My cancer has returned once or twice after initial treatment.
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My brain tumor is a Grade IV glioblastoma without IDH mutation.
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Select...
I can provide a tissue sample from my tumor for testing.
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I have waited the required time after my last cancer treatment before joining this trial.
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My brain tumor is a type of aggressive cancer known as glioblastoma.
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Select...
I have recovered from major side effects of my previous treatments.
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I have enough tissue from a previous surgery for testing.
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I am able to care for myself but may not be able to do active work.
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My condition has worsened for the first or second time after improving.
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I have received radiotherapy as my first treatment.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with specific immune therapy drugs before.
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I haven't had severe bleeding in the last 6 months.
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I have another cancer that is getting worse or needs treatment.
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I have had specific local treatments like brachytherapy or stereotactic surgery.
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I am currently being treated for an infection.
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I have not received a live vaccine in the last 30 days.
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My cancer has an IDH mutation.
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I have an active tuberculosis infection.
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I have been diagnosed with an immune system disorder.
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I need high dose steroids (more than 2 mg/day of dexamethasone or equivalent) for at least 3 days.
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My cancer has spread to the lining of my brain or other parts of my body.
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Select...
I have not taken immunosuppressive drugs, except steroids, in the last 6 months.
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I have been treated for an autoimmune disease in the last 2 years.
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My tumor is mainly in my brainstem or spinal cord.
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I have received treatments like bevacizumab or aflibercept.
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I have a history of or currently have non-infectious lung inflammation.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pharmacotherapy
Tumor Infiltrating T Lymphocyte (TIL) Density
Secondary study objectives
Cell Cycle-Related Genetic Signature within the Tumor Microenvironment
Percentage of Progression Free Survival (PFS-6)
Side effects data
From 2023 Phase 3 trial • 521 Patients • NCT0410906665%
Alopecia
48%
Nausea
37%
Anaemia
27%
Fatigue
25%
Aspartate aminotransferase increased
24%
Diarrhoea
21%
Alanine aminotransferase increased
21%
Asthenia
20%
Vomiting
20%
Neuropathy peripheral
19%
Headache
19%
Neutropenia
18%
Constipation
17%
COVID-19
17%
Arthralgia
16%
Neutrophil count decreased
15%
Hypothyroidism
14%
Rash
13%
Decreased appetite
12%
Hyperglycaemia
12%
Lymphopenia
12%
White blood cell count decreased
12%
Radiation skin injury
11%
Myalgia
10%
Cough
9%
Infusion related reaction
9%
Hypertension
9%
Urinary tract infection
9%
Epistaxis
9%
Pruritus
9%
Pyrexia
8%
Blood alkaline phosphatase increased
7%
Dysgeusia
7%
Dizziness
7%
Hot flush
7%
Dyspepsia
6%
Paraesthesia
6%
Hypersensitivity
6%
Weight decreased
6%
Mucosal inflammation
6%
Abdominal pain upper
6%
Peripheral sensory neuropathy
6%
Insomnia
6%
Illness
6%
Back pain
6%
Hyperthyroidism
6%
Pain in extremity
6%
Leukopenia
5%
Blood lactate dehydrogenase increased
5%
Anxiety
5%
Folliculitis
5%
Abdominal pain
4%
Oedema peripheral
4%
Adrenal insufficiency
4%
Blood thyroid stimulating hormone increased
4%
Dry mouth
4%
Pain
3%
Lymphocyte count decreased
3%
Dry eye
3%
Nasopharyngitis
3%
Lacrimation increased
3%
Gastrooesophageal reflux disease
3%
Stomatitis
3%
Breast pain
3%
Blood thyroid stimulating hormone decreased
3%
Hypokalaemia
3%
Dyspnoea
3%
Hyponatraemia
2%
Rash maculo-papular
2%
Rhinorrhoea
2%
Onycholysis
2%
COVID-19 pneumonia
2%
Malignant neoplasm progression
2%
Depression
2%
Oropharyngeal pain
2%
Bone pain
2%
Thrombocytopenia
2%
Pulmonary embolism
2%
Dry skin
2%
Procedural pain
2%
Tachycardia
2%
Palpitations
2%
Febrile neutropenia
2%
Postoperative wound infection
2%
Nail disorder
2%
Lymphoedema
1%
Hepatitis cholestatic
1%
Arterial thrombosis
1%
Thyroiditis subacute
1%
Cervix carcinoma
1%
Upper respiratory tract infection
1%
Myocardial infarction
1%
Vertigo
1%
Pemphigoid
1%
Hypotension
1%
Cardiac perfusion defect
1%
Cardio-respiratory arrest
1%
Anaphylactic reaction
1%
Myelosuppression
1%
Infection
1%
Pneumonia bacterial
1%
Glomerulonephritis
1%
Chills
1%
Immune-mediated adrenal insufficiency
1%
Colitis
1%
Diabetic ketoacidosis
1%
Embolism
1%
Intracranial pressure increased
1%
Cardiac failure
1%
Pneumonia
1%
Myocarditis
1%
Interstitial lung disease
1%
Left ventricular failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET
Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET
Trial Design
3Treatment groups
Experimental Treatment
Group I: Placebo-Nivolumab and Placebo-Ipilimumab Before Surgery, Nivolumab and Ipilimumab After SurgeryExperimental Treatment5 Interventions
One dose of placebo-nivolumab plus placebo-ipilimumab will be administered 14(±5) days before surgery.
After surgery, participants receive nivolumab in combination with ipilimumab every 3 weeks for 9 weeks and then nivolumab alone every 4 weeks
Group II: Nivolumab and Placebo-Ipilimumab Before Surgery, Nivolumab After SurgeryExperimental Treatment3 Interventions
One dose of nivolumab plus placebo-ipilimumab will be administered 14(±5) days before surgery.
After surgery, participants receive nivolumab in combination with ipilimumab every 3 weeks for 9 weeks and then nivolumab alone every 4 weeks.
Group III: Nivolumab and Ipilimumab Before and After SurgeryExperimental Treatment3 Interventions
One dose of nivolumab plus ipilimumab will be administered 14(±5) days before surgery.
After surgery, participants receive nivolumab in combination with ipilimumab every 3 weeks for 9 weeks and then nivolumab alone every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~3880
Ipilimumab
2015
Completed Phase 3
~3380
Surgery
2000
Completed Phase 3
~2490
Find a Location
Closest Location:Memorial Sloan Kettering Cancer Center· New York, NY· 480 miles
Who is running the clinical trial?
Patrick Wen, MDLead Sponsor
2 Previous Clinical Trials
538 Total Patients Enrolled
2 Trials studying Glioblastoma
538 Patients Enrolled for Glioblastoma
Patrick Y. Wen, MDLead Sponsor
9 Previous Clinical Trials
928 Total Patients Enrolled
7 Trials studying Glioblastoma
843 Patients Enrolled for Glioblastoma
Bristol-Myers SquibbIndustry Sponsor
2,721 Previous Clinical Trials
4,128,306 Total Patients Enrolled
19 Trials studying Glioblastoma
2,753 Patients Enrolled for Glioblastoma
Patrick Y Wen, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
722 Total Patients Enrolled
4 Trials studying Glioblastoma
722 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My MRI shows my tumor is growing.You have mental health or addiction issues that could prevent you from following the trial requirements.You are currently or planning to participate in a study involving an experimental drug or device.It's been over 12 weeks since my last radiation therapy, or I have confirmed tumor growth.My doctor has determined that I need surgery.You are allergic to any of the medications being used in the study.I have received radiotherapy as my first treatment.I have been treated with specific immune therapy drugs before.My MRI shows my tumor is growing.I haven't had severe bleeding in the last 6 months.I have another cancer that is getting worse or needs treatment.My cancer has returned once or twice after initial treatment.My brain tumor is a Grade IV glioblastoma without IDH mutation.I have had specific local treatments like brachytherapy or stereotactic surgery.I can provide a tissue sample from my tumor for testing.I am currently being treated for an infection.It has been over 4 weeks since my last surgery or 1 week since my biopsy.I have not received a live vaccine in the last 30 days.I have recovered from major side effects of my previous treatments, except for hair loss and low lymphocyte count.My cancer has an IDH mutation.I have waited the required time after my last cancer treatment before joining this trial.I have an active tuberculosis infection.I have been diagnosed with an immune system disorder.It has been over 4 weeks since my last surgery or 1 week since my biopsy.I need high dose steroids (more than 2 mg/day of dexamethasone or equivalent) for at least 3 days.I am a woman who can have children and have a recent negative pregnancy test.My brain tumor is a type of aggressive cancer known as glioblastoma.I have recovered from major side effects of my previous treatments.My cancer has spread to the lining of my brain or other parts of my body.My recent tests show my organs are working well.I have enough tissue from a previous surgery for testing.I agree to use contraception during and for 7 months after my treatment.I have not taken immunosuppressive drugs, except steroids, in the last 6 months.I have waited the required time after my last cancer treatment before joining this trial.It's been over 12 weeks since my last radiation therapy, or I have confirmed tumor growth.I am able to care for myself but may not be able to do active work.My condition has worsened for the first or second time after improving.I have been treated for an autoimmune disease in the last 2 years.My tumor is mainly in my brainstem or spinal cord.My doctor has decided that I need surgery.I have a bleeding disorder or had significant bleeding in the last year.I have received treatments like bevacizumab or aflibercept.I have received radiotherapy as my first treatment.I have a history of or currently have non-infectious lung inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab and Ipilimumab Before and After Surgery
- Group 2: Nivolumab and Placebo-Ipilimumab Before Surgery, Nivolumab After Surgery
- Group 3: Placebo-Nivolumab and Placebo-Ipilimumab Before Surgery, Nivolumab and Ipilimumab After Surgery
Awards:
This trial has 0 awards, including: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.