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Checkpoint Inhibitor

Ipilimumab + Nivolumab + Radiation for Glioblastoma

Phase 2 & 3

Waitlist Available

Led By Andrew B Lassman

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

MGMT promoter without methylation confirmed by central pathology review

IDH mutation testing with no mutation found

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is testing whether adding immunotherapy to radiation therapy can help people with newly diagnosed glioblastoma that has an unmethylated MGMT.

Who is the study for?

Adults with newly diagnosed MGMT unmethylated glioblastoma who've had surgery can join. They need a good performance status, no prior tumor treatments except resection, and no history of severe allergies to the drugs being tested or other cancers in the last 2 years. Women must not be pregnant and participants should use contraception.Check my eligibility

What is being tested?

The trial is testing if combining radiation therapy with immunotherapy drugs Ipilimumab and Nivolumab improves outcomes compared to the usual treatment of radiation therapy plus Temozolomide for this type of brain cancer. It's looking at whether these new drugs help patients live longer without their tumor growing back.See study design

What are the potential side effects?

Ipilimumab and Nivolumab might cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems (like thyroid), fatigue, and flu-like symptoms. Temozolomide may lead to nausea, hair loss, tiredness, constipation or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer's MGMT gene is not methylated as confirmed by a specialized lab.

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My cancer does not have an IDH mutation.

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I am 18 years old or older.

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My glioblastoma diagnosis has been confirmed by a specialized review.

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I am able to care for myself but may not be able to do active work.

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My cancer does not have an IDH mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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 survival (OS) (Phase III)

Progression-free survival (PFS) (Phase II)

Secondary outcome measures

Comparative frequency of specific adverse events of interest

Frequency summaries for all adverse event types

Neurocognitive function (NCF)

+4 more

Other outcome measures

MGMT protein expression

OS (if the study discontinues in phase II)

Tumor biomarker analyses

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

Pain in extremity

Weight decreased

Leukopenia

Alanine aminotransferase increased

Hyponatraemia

Pneumonia

Haemoglobin decreased

Neutrophil count decreased

Dizziness

Malignant neoplasm progression

Aspartate aminotransferase increased

Bone pain

Haemoptysis

Back pain

Headache

Hypomagnesaemia

Stomatitis

Abdominal pain upper

Oedema peripheral

White blood cell count decreased

Chest pain

Dehydration

Abdominal pain

Febrile neutropenia

Paraesthesia

Musculoskeletal pain

Colitis

Death

Lung infection

Pulmonary embolism

Mucosal inflammation

Multi-organ failure

Cerebrovascular accident

Lung neoplasm malignant

Lung abscess

General physical health deterioration

Interstitial lung disease

Liver function test abnormal

Sudden death

Chronic obstructive pulmonary disease

Metastases to central nervous system

Blood creatinine increased

Atrial fibrillation

Cardio-respiratory arrest

Confusional state

Intestinal perforation

Pulmonary haemorrhage

Drug hypersensitivity

Infection

Pneumothorax

Renal failure

Lower respiratory tract infection

Pain

Respiratory failure

Syncope

Hyperglycaemia

Sepsis

Acute kidney injury

Hypersensitivity

Urinary tract infection

Disease progression

Pneumonitis

100%

80%

60%

40%

20%

Study treatment Arm

10 MG/KG Ipilimumab + Paclitaxel/ Carbop

Placebo + Paclitaxel/ Carboplatin

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (radiation therapy, ipilimumab, nivolumab)Experimental Treatment6 Interventions

Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.

Group II: Arm I (radiation therapy, temozolomide)Active Control6 Interventions

Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~2620

Contrast-enhanced Magnetic Resonance Imaging

2005

Completed Phase 1

~320