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Checkpoint Inhibitor

Immune Checkpoint Inhibitors + Temozolomide for Brain Cancer

Phase 2
Recruiting
Led By Mark R Gilbert, M.D.
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
Karnofsky greater than or equal to 70%
Patient must have completed chemoradiation (external beam radiation with concurrent temozolomide) a maximum of 5 weeks prior to initiation of study therapy
Must not have
- Known active, chronic or history of hepatitis infection
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations (within timeframes identified in the bullets below) that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up death
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the changes in immune cells in the blood of people with newly diagnosed GBM or gliosarcoma, who take ipilimumab and nivolumab, along with temozolomide.

Who is the study for?
Adults over 18 with newly diagnosed GBM or gliosarcoma who've had surgery to remove their tumor and completed initial chemo and radiation. They must be in good health, have a Karnofsky score of at least 70%, agree to use two forms of contraception, and not be pregnant or breastfeeding.
What is being tested?
The trial is testing the combination of nivolumab and ipilimumab immunotherapies with temozolomide chemotherapy in patients with brain tumors. It aims to understand how these treatments affect immune cells in the blood. Treatment cycles last four weeks, including IV infusions and oral medication.
What are the potential side effects?
Possible side effects include immune-related reactions that can affect various organs, infusion-related symptoms, fatigue, digestive issues like nausea or diarrhea, skin rashes, hormonal imbalances (endocrine issues), liver function changes, and increased risk for infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly able to care for myself.
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I finished my chemoradiation treatment no more than 5 weeks ago.
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I have been recently diagnosed with glioblastoma or gliosarcoma.
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My organs and bone marrow are functioning well.
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My kidney function is normal, with creatinine levels at or below 1.7 mg/dL.
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I had surgery to remove almost all of a brain tumor located above the cerebellum.
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I am 18 years old or older.
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I am using a barrier method of contraception.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had hepatitis.
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I do not have any uncontrolled illnesses that could interfere with the study.
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I am allergic to medications similar to nivolumab, ipilimumab, or temozolomide.
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I do not have an active or history of severe autoimmune disease.
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My cancer is getting worse, as shown by tests or scans.
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I am not pregnant or breastfeeding.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Secondary study objectives
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 overall survival, evaluating 2 different dosing regimens of the ICIs.
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.
+2 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment3 Interventions
Nivolumab + Ipilimumab 3mg/kg + TMZ
Group II: Arm 1Experimental Treatment3 Interventions
Nivolumab + Ipilimumab 1mg/kg + TMZ
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TMZ
2007
Completed Phase 3
~1530
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,965 Total Patients Enrolled
5 Trials studying Gliomas
292 Patients Enrolled for Gliomas
Mark R Gilbert, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
3,401 Total Patients Enrolled
Marta Penas-Prado, M.D.Principal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04817254 — Phase 2
Gliomas Research Study Groups: Arm 1, Arm 2
Gliomas Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04817254 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817254 — Phase 2
~19 spots leftby Nov 2025
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