Nivolumab for Glioblastoma

Phase-Based Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Glioblastoma+3 More
Nivolumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Glioblastoma

Study Summary

Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

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Eligible Conditions

  • Glioblastoma
  • Gliosarcoma
  • Glioma
  • Gliomas, Malignant

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Nivolumab will improve 1 primary outcome and 5 secondary outcomes in patients with Glioblastoma. Measurement will happen over the course of death.

Day 100
Determine if the T cell response measured by the ex vivo tosylactivated bead assay correlates with subsequent systemic response to treatment with immune checkpoint inhibitors.
Study Calendar, last collection of QOL Questioner
Evaluate changes in patient reported outcome measures using self-reported symptom severity and interference with daily activities using the MDASI-BT with treatment response and progression-free and overall survival.
death
Determine if in vitro peripheral blood T cell response to a stimulation paradigm including nivolumab and ipilimumab correlates with overall survival, evaluating 2 different dosing regimens of the ICIs.
Determine if the outcomes, as measured by overall survival, is improved in patients with newly diagnosed glioblastoma when treatment with immune checkpoint inhibitors result in an immune response in peripheral blood T lymphocytes.
disease progression
Determine if T cell response to immune checkpoint inhibitors measuring the change in the pre-treatment and post-treatment blood correlates with progression-free survival
Determine if in vitro peripheral blood T cell response to a stimulation paradigm including nivolumab and ipilimumab correlates with progression-free survival, evaluating 2 different dosing regimens of the ICIs.

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
Arm 2

This trial requires 48 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nivolumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm 2Nivolumab + Ipilimumab 3mg/kg + TMZ
Arm 1Nivolumab + Ipilimumab 1mg/kg + TMZ
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
TMZ
2007
Completed Phase 3
~1580

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: disease progression
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly disease progression for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Glioblastoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have finished chemoradiation (external beam radiation with concurrent temozolomide) at most 5 weeks earlier to start the study's treatment. show original
Hemoglobin should be at least 9.0 g/dL to avoid transfusions. show original
A person has a BUN of less than or equal to 30 mg/dL if their blood uric acid level is 30 mg/dL or less. show original
Results of the study indicated that serum creatinine less than or equal to 1.7 mg/dL and creatinine clearance as measured by 24 hour urine collection as > 60 ml/min were both associated with a low rate of renal dysfunction. show original
according to the revised 2015 World Health Organization (WHO) classification to be eligible for the study In order to be eligible for the study, patients must have a newly diagnosed histologically confirmed primary glioblastoma or gliosarcoma according to the revised 2015 World Health Organization (WHO) classification. show original
This patient has a high platelet count. show original
Patients who have had a tumor resected must have had a tumor that was confined to the upper part of the brain and was not more than one focus. show original
You must be at least 18 years old to purchase this product. show original
This person's Karnofsky performance status is greater than or equal to 70%. show original
and less than or equal to 10,000/mcL show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is nivolumab?

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Nivolumab seems to be an intriguing drug for the treatment of GBM patients. In a recent study, findings suggest that Nivolumab could be proposed as second line treatment in GBM patients.

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How does nivolumab work?

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A single dose of Nivolumab did not prolong life and was very ineffective in a murine GBM xenograft model. It did, however, reduce tumor size (with a dose of 1mg/kg) in several murine GBM strains.

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What causes glioblastoma?

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It is widely agreed that glioblastomas arise from the malignant transformation of neural stem cells present in the CNS during development. However, the role of genetics, environment, and environmental factors in gliomagenesis are much debated. Here we discuss the role of these variables in the development of primary glioblastoma.

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What are common treatments for glioblastoma?

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The treatment response rates for the treatment of GBM have increased in the past two decades. However, the overall survival of the patients diagnosed with GBM is still poor. In the absence of an effective treatment of GBM, the quality of life of these patients still has a high mortality.

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What is glioblastoma?

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The average survival rate for glioblastoma patients is 7.1 months, and there has been a significant increase in the number of long-term survivors over the last 60 years. However, there is still a great need for a new treatment and for further research in order to develop a more effective and safer chemotherapy regimen.

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What are the signs of glioblastoma?

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Tumor-related encephalopathy, headache, vertigo, seizures, nausea and vomiting in glioblastoma patients are often accompanied by abnormal neurological examinations. A non-specific EEG is highly indicated with an increased voltage.

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Can glioblastoma be cured?

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GBM cannot be cured even in very early stage, but surgical debulking, concurrent radiation and chemotherapy, and targeted therapy could reduce the tumor volume, decrease the edema and limit the progression of GBM. If these drugs can alleviate the pain and elevate the QL, then the patient's life quality can be markedly improved.

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How many people get glioblastoma a year in the United States?

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In the US, Glioblastoma occurs an estimated 5.1 times more often than in Canada (odds ratio, 5.9; 95% CI, 3.9-8.8); the median age at diagnosis was lower (63 years) and the proportions of female (62.7%) vs males (36.8%) in the USA were higher. Further evaluation of associations with environmental radiation, and particularly radiation dose in this area is warranted to verify and further elucidate this unusual distribution and to identify potentially useful preventive measures to protect persons exposed in this area to radiation.

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What is the survival rate for glioblastoma?

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Survival rates for glioblastoma have remained stable and are worse than other brain tumours. There has been a decline in the overall 5 year survival rate in recent years, but this is still better than the survival rates previously reported. These survival rates are likely to represent more appropriately selected patients, as most current patients are younger and healthier. Despite the advances in treatment and in surgical techniques, improvements in diagnostic techniques and in chemotherapy regimens, patients with glioblastoma have still not achieved the best long-term survival rates in the last 7 years, for which improvements are likely in the near future.

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What are the common side effects of nivolumab?

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Nivolumab did not appear to cause new or worsening side effects in any of the patients in the studies, although its limited duration of treatment made it very difficult to collect sufficient information to document all adverse events.

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Does glioblastoma run in families?

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This is the first study that specifically considers the question of family history of cancer in patients with glioblastoma treated with clinical conventional therapy in the U.K. It is reported that there may be an increase or no increase in family history of cancer in patients that have glioblastoma treated with clinical conventional therapy. This may represent a novel target for future genotype based pharmacogenetic studies or tailored personalized therapy.

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Is nivolumab typically used in combination with any other treatments?

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The combination of NIV with checkpoint inhibition is not uncommon in the treatment of metastatic malignancies, including advanced renal cell carcinoma, squamous cell carcinoma, and metastatic non-small cell lung cancer.

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