Ipilimumab for Recurrent Glioblastoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Moffitt Cancer Center, Tampa, FL
Recurrent Glioblastoma+1 More
Ipilimumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called nivolumab is better than a drug called bevacizumab in treating brain cancer.

See full description

Eligible Conditions

  • Recurrent Glioblastoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Recurrent Glioblastoma

Study Objectives

This trial is evaluating whether Ipilimumab will improve 12 primary outcomes and 8 secondary outcomes in patients with Recurrent Glioblastoma. Measurement will happen over the course of Includes events reported between first dose and 30 days after last dose of study therapy (up to 3 doses, up to approximately 2 months).

12 months
Cohort 2: Overall Survival rate (OS) at 12 months
Approximately 36 months
Cohort 1c and 1d: Overall Survival rate (OS)
Cohort 2: Objective Response Rate (ORR)
Cohort 2: Overall Survival (OS)
Cohort 2: Progression Free Survival (PFS)
Month 8
Percentage of Participants with Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Percentage of Participants with Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses
Percentage of Participants with Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Percentage of Participants with Specific Laboratory Abnormalities in Liver Tests (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Percentage of Participants with Specific Laboratory Abnormalities in Thyroid Tests (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Month 34
Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
Month 12
Overall Survival (OS) at 12 Months for Cohort 2
Month 2
Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses
Year 5
Overall Survival (OS) for Cohort 2
Overall Survival (OS) for Cohorts 1c and 1d
Year 5
Progression Free Survival (PFS) for Cohort 2
Month 31
Objective Response Rate (ORR) for Cohort 2

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Recurrent Glioblastoma

Trial Design

3 Treatment Groups

Arm B: Bevacizumab
1 of 3
Arm N:Nivolumab
1 of 3
Arm N + I:Nivolumab + Ipilimumab
1 of 3
Active Control
Experimental Treatment

This trial requires 529 total participants across 3 different treatment groups

This trial involves 3 different treatments. Ipilimumab 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 3 and have had some early promising results.

Arm N:Nivolumab
Biological
Cohort 1, 1c, 1d and 2: Nivolumab specified dose on specified days
Arm N + I:Nivolumab + IpilimumabCohort 1: Nivolumab specified dose on specified days + Ipilimumab specified dose on specified days, then Nivolumab specified dose on specified days Cohort 1b: Nivolumab specified dose on specified days + Ipilimumab specified dose on specified days, then Nivolumab specified dose on specified days
Arm B: Bevacizumab
Biological
Cohort 2: Bevacizumab specified dose on specified days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time between the date of randomization and the date of death due to any cause (up to 17jun2019, approximately 5 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly time between the date of randomization and the date of death due to any cause (up to 17jun2019, approximately 5 years) for reporting.

Closest Location

Moffitt Cancer Center - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Recurrent Glioblastoma or the other condition listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants with histologically confirmed Grade IV malignant glioma
You have previously received radiotherapy and temozolomide. show original
You have had a first recurrence of glioblastoma multiforme. show original
First diagnosis of GBM with resectable disease (Cohorts 1c Part A only)
You have a first diagnosis of MGMT GBM. show original
Karnofsky performance score of 70 or higher

Patient Q&A Section

What causes glioblastoma?

"Tumor heterogeneity, epigenetic regulation, and the expression of specific oncogenic signaling pathways are implicated in glioblastoma. Furthermore, the loss of the PTEN tumor suppressor gene and amplification of the IDO pathway characterize this tumor type and may represent a potential therapeutic target." - Anonymous Online Contributor

Unverified Answer

What are the signs of glioblastoma?

"Data from a recent study suggest that the majority of patients (75%) had at least one symptom in the 1-year period before diagnosis. The most frequent symptoms were headache (49%), seizures (46%), and vomiting (25%). Because glioblastoma has a very short survival, patients should be given a careful assessment of symptoms in the 1st months to 1-year period post-diagnosis and encouraged to report any suspicious symptoms to the doctors." - Anonymous Online Contributor

Unverified Answer

What is glioblastoma?

"In the United States approximately 70,000 patients are diagnosed with glioblastoma and 10-13,400 dying of the disease per year. These deaths are due to the high relapse rate and the long period between diagnosis and relapse, sometimes over 10 months. There is also a great disparity in the survival for patients with different subtypes of glioblastoma, where about 5% of patients survive a year after diagnosis, compared with around 50% who survive for 2 months or more following their initial treatment. There is also a difference between genders where around 33% of females have an overall survival of less than 2 months." - Anonymous Online Contributor

Unverified Answer

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

"Glioblastomas are the most common primary brain malignancy in children (aged 3-19), with the majority of cases being WHO grade 4 astrocytomas. Despite the increase in the number of cases, the survival rates are less favorable than the reported survival rate for tumors in other brain regions. This is likely attributable to the heterogeneity in the patient population, and an array of pathogeneses at play that requires further exploration." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioblastoma?

"While chemotherapy is the first choice for newly diagnosed cases that fail to respond to surgery, radiation therapy is frequently initiated in the second line when the first-line regimen fails. For relapse or for recurrent disease, chemotherapy with a second-line agent may be given, and radiotherapy may be considered if chemotherapy does not resolve the disease." - Anonymous Online Contributor

Unverified Answer

Can glioblastoma be cured?

"Currently, the only potentially curative therapy for GBM is GBM surgery. However, a percentage of patients will experience tumor recurrence, even in low-grade gliosarcomas, necessitating subsequent chemotherapy to achieve prolonged survival. Even in patients with low-grade tumors, the rate of progression is high. Long-term disease-free survival is achievable only rarely. In a recent multicenter phase III study, only 23% of patients had a long-term progression-free survival, as determined by an extension of the mean survival of the initial population. Because of the low long-term survival rate, we believe that GBM cannot be cured." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of ipilimumab?

"These side effects occurred in most patients and did not cause dosage adjustments. In some patients, side effects were persistent. All patients experienced fatigue, and one patient experienced diarrhea and myelosuppression. Mild nausea and rash occurred occasionally. No other side effects were notable." - Anonymous Online Contributor

Unverified Answer

What is ipilimumab?

"Clinical trials of ipilimumab were published in the peer-reviewed literature in 2008 and 2009. A summary is presented with references for those publications which may be of interest to the patient/physician at hand. The clinical trial studies include 1. Phase II trials for refractory melanoma and renal and hepatocellular carcinoma. These trials include patients with advanced solid organ tumors, including gastrointestinal stromal tumor (GIST) and pancreatic neuroendocrine carcinoma. These patients were treated for advanced cancers with a variety of immunotherapies including ipilimumab. 2." - Anonymous Online Contributor

Unverified Answer

Is ipilimumab safe for people?

"Ipilimumab is safe in people with metastatic cancer of any type. There was no evidence of significant neurological side effects. Ipilimumab should be avoided in people with known hypersensitivity to pembrolizumab or any of the active ingredients except for ipilimumab" - Anonymous Online Contributor

Unverified Answer

How quickly does glioblastoma spread?

"In the case of GBM, when there were several sites of dissemination at presentation and the patient had undergone surgery, chemotherapy, and radiotherapy, the disease tended to remain localised. However, when only sites close to the tumour arose from the dissemination of the tumour, the disease often grew systemically and invaded other sites. An overview of this is illustrated in the image in this section. This may help physicians to decide whether to administer radiotherapy or chemotherapy after surgery to prevent disease spread." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets glioblastoma?

"The majority of patients diagnosed with glioblastoma are younger than is typically reported. These data call into question what the true prevalence of the disease is and whether the current diagnostic criteria are appropriate." - Anonymous Online Contributor

Unverified Answer

Does glioblastoma run in families?

"In a recent study, findings provides evidence that siblings of glioblastoma patients appear to have an increased risk of developing glioblastoma. However, the relative risk is small and not statistically significant when adjusting for environmental factors known to affect the incidence of glioblastoma. The significance of these findings will require further confirmation." - Anonymous Online Contributor

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