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Checkpoint Inhibitor

Immunotherapy for Brain Tumor

Phase 2
Waitlist Available
Led By Gavin P Dunn
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing immunotherapy drugs to treat patients with recurrent glioma who have a high number of mutations. The drugs may help the body's immune system attack the cancer and lower the chance of the cancer growing or spreading.

Who is the study for?
Adults (18+) with recurrent glioma, specifically high-grade glioblastomas or astrocytomas at first or second recurrence. Participants must have measurable disease on MRI and not be on high doses of steroids. No history of autoimmune diseases, no prior immunotherapy or bevacizumab, and should meet certain blood test criteria for organ function.Check my eligibility
What is being tested?
The trial is testing the effectiveness of two immunotherapy drugs, Ipilimumab and Nivolumab, in patients with a type of brain tumor called glioma that has returned after treatment. The study focuses on tumors with a high number of genetic mutations to see if these drugs can help the immune system fight cancer better than current treatments.See study design
What are the potential side effects?
Ipilimumab and Nivolumab may cause immune-related side effects such as inflammation in various organs including the intestines, liver, skin, hormone glands; potential lung issues like pneumonitis; infusion reactions; fatigue; skin rash; and could worsen any underlying autoimmune conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate
Secondary outcome measures
Incidence of adverse events (AEs)
Overall survival (OS)
Progression-free survival (PFS)

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung neoplasm malignant
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, ipilimumab)Experimental Treatment3 Interventions
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,630 Total Patients Enrolled
322 Trials studying Glioblastoma
23,078 Patients Enrolled for Glioblastoma
Gavin P DunnPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04145115 — Phase 2

Frequently Asked Questions

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

For what purpose is Ipilimumab most commonly given to patients?

"Ipilimumab is most often used as a second-line therapy, but it can also be used to treat certain malignant neoplasms, unresectable melanomas, and squamous cell carcinomas."

Answered by AI

What does the research history of Ipilimumab tell us about its potential?

"In 2009, ipilimumab was studied for the first time at Texas Children's Hospital. 362 trials have been completed in the years since while 796 more are currently ongoing. Many of these active trials are being conducted in Dayton, Ohio."

Answered by AI

How many participants are being allowed into this trial?

"37 patients that meet the pre-specified medical criteria are required to fully staff this clinical trial. Those willing to participate can do so from various locations, such as Miami Valley Hospital North or Kootenai Health - Coeur d'Alene."

Answered by AI

Could you please summarize the safety profile of Ipilimumab?

"While there is some data supporting the safety of Ipilimumab, it only received a score of 2 because there is no data indicating that it is an effective medication."

Answered by AI

Are new participants being accepted into this clinical trial at this time?

"Yes, this trial is still recruiting patients according to the information on clinicaltrials.gov. The listing was first posted on October 30th 2020 and updated most recently on November 2nd 2022."

Answered by AI

Is this trial being conducted in more than one location within the city limits?

"There are 100 patients recruited for this study from Miami Valley Hospital North in Dayton, Kootenai Health - Coeur d'Alene in Coeur d'Alene, Saint Luke's Cancer Institute - Meridian in Meridian, and other locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden
2020. "A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04145115.
~9 spots leftby May 2025
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