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Checkpoint Inhibitor
Nivolumab + Ipilimumab with Surgery for Glioblastoma
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study 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.
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.
Select...
My cancer has returned once or twice after initial treatment.
Select...
My brain tumor is a Grade IV glioblastoma without IDH mutation.
Select...
I can provide a tissue sample from my tumor for testing.
Select...
I have waited the required time after my last cancer treatment before joining this trial.
Select...
My brain tumor is a type of aggressive cancer known as glioblastoma.
Select...
I have recovered from major side effects of my previous treatments.
Select...
I have enough tissue from a previous surgery for testing.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharmacotherapy
Tumor Infiltrating T Lymphocyte (TIL) Density
Secondary outcome measures
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
36%
Anaemia
26%
Fatigue
25%
Aspartate aminotransferase increased
24%
Diarrhoea
21%
Alanine aminotransferase increased
20%
Vomiting
20%
Asthenia
19%
Headache
19%
Neuropathy peripheral
19%
Neutropenia
17%
Constipation
16%
COVID-19
16%
Neutrophil count decreased
15%
Arthralgia
14%
Rash
13%
Decreased appetite
13%
Hypothyroidism
12%
Hyperglycaemia
12%
White blood cell count decreased
12%
Radiation skin injury
11%
Lymphopenia
11%
Myalgia
9%
Infusion related reaction
9%
Cough
9%
Pruritus
9%
Pyrexia
9%
Urinary tract infection
9%
Epistaxis
9%
Hypertension
8%
Blood alkaline phosphatase increased
7%
Dizziness
7%
Dyspepsia
7%
Dysgeusia
7%
Hot flush
6%
Peripheral sensory neuropathy
6%
Paraesthesia
6%
Abdominal pain upper
6%
Back pain
6%
Pain in extremity
6%
Illness
6%
Mucosal inflammation
6%
Leukopenia
6%
Hypersensitivity
6%
Hyperthyroidism
6%
Insomnia
5%
Anxiety
5%
Weight decreased
5%
Blood lactate dehydrogenase increased
5%
Folliculitis
4%
Abdominal pain
4%
Blood thyroid stimulating hormone increased
4%
Dry mouth
4%
Adrenal insufficiency
4%
Oedema peripheral
4%
Pain
3%
Blood thyroid stimulating hormone decreased
3%
Dyspnoea
3%
Hyponatraemia
3%
Stomatitis
3%
Dry eye
3%
Lacrimation increased
3%
Gastrooesophageal reflux disease
3%
Nasopharyngitis
3%
Lymphocyte count decreased
3%
Hypokalaemia
2%
Nail disorder
2%
Pulmonary embolism
2%
Rash maculo-papular
2%
Postoperative wound infection
2%
Bone pain
2%
Breast pain
2%
Thrombocytopenia
2%
Depression
2%
Palpitations
2%
Dry skin
2%
Onycholysis
2%
Malignant neoplasm progression
2%
Febrile neutropenia
2%
COVID-19 pneumonia
2%
Tachycardia
2%
Procedural pain
2%
Oropharyngeal pain
1%
Left ventricular failure
1%
Thyroiditis subacute
1%
Cervix carcinoma
1%
Interstitial lung disease
1%
Upper respiratory tract infection
1%
Embolism
1%
Cardiac perfusion defect
1%
Pneumonia bacterial
1%
Cardiac failure
1%
Vertigo
1%
Myocarditis
1%
Pemphigoid
1%
Immune-mediated adrenal insufficiency
1%
Hypotension
1%
Chills
1%
Pneumonia
1%
Myelosuppression
1%
Intracranial pressure increased
1%
Cardio-respiratory arrest
1%
Myocardial infarction
1%
Colitis
1%
Anaphylactic reaction
1%
Diabetic ketoacidosis
1%
Hepatitis cholestatic
1%
Infection
1%
Glomerulonephritis
1%
Arterial thrombosis
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
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Surgery
2000
Completed Phase 3
~2550
Find a Location
Who is running the clinical trial?
Patrick Wen, MDLead Sponsor
2 Previous Clinical Trials
328 Total Patients Enrolled
2 Trials studying Glioblastoma
328 Patients Enrolled for Glioblastoma
Patrick Y. Wen, MDLead Sponsor
9 Previous Clinical Trials
718 Total Patients Enrolled
7 Trials studying Glioblastoma
633 Patients Enrolled for Glioblastoma
Bristol-Myers SquibbIndustry Sponsor
2,645 Previous Clinical Trials
4,130,936 Total Patients Enrolled
19 Trials studying Glioblastoma
2,753 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA provided approval for surgical operations?
"Since this is a Phase 1 clinical trial, with limited evidence of safety and efficacy, the risk associated with Surgery was given an assessment of 1."
Answered by AI
Have there been prior investigations examining the implications of Surgery?
"At this time, there are 764 trials that study the utilization of Surgery with 86 in Phase 3. Particularly, Pittsburgh, Pennsylvania has several active studies; but globally there exists 42751 such research sites."
Answered by AI
Are there multiple health care facilities testing this in the United States?
"4 sites are currently accepting enrolments in this trial, such as the University of California Los Angeles in LA and Dana Farber Cancer Institute in Boston. Additionally, Memorial Sloan Kettering Cancer Center is located in New york City with an additional 4 locations elsewhere."
Answered by AI
Is there a cap on the number of participants in this clinical research project?
"Bristol-Myers Squibb, the sponsor of this research, necessitates 60 patients who fulfill the study's criteria for inclusion. The clinical trial will be conducted from 3 sites located in Los Angeles (University of California Los Angeles), Massachusetts and Boston (Dana Farber Cancer Institute) as well as New york."
Answered by AI
In what scenarios is Surgery the primary treatment option?
"Surgery is a typical treatment for post-angiogenic therapies, as well as malignant neoplasms, melanoma which cannot be removed surgically, and squamous cell carcinomas."
Answered by AI
Is this clinical trial accepting new participants at the present time?
"Confirmed. According to clinicaltrials.gov, this study has been recruiting since February 1st 2021 and the most recent edition was on November 16th 2022. There are 4 trial sites currently contributing to a total of 60 patients needed for the research project."
Answered by AI
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