IPI-GLIO: Ipilimumab in Recently Diagnosed Glioblastoma
Research type
Research Study
Full title
A Phase II, Open Label, Randomised Study of Ipilimumab With Temozolomide Versus Temozolomide Alone after Surgery and Chemoradiotherapy in Patients with Recently Diagnosed Glioblastoma (IPI-GLIO)
IRAS ID
238638
Contact name
Paul Mulholland
Contact email
Sponsor organisation
University of Oxford
Eudract number
2018-000095-15
Duration of Study in the UK
6 years, 11 months, 30 days
Research summary
Research Summary:
IPI-GLIO: A Phase II, Open Label, Randomised Study of Ipilimumab with Temozolomide versus Temozolomide alone after surgery and chemoradiotherapy in patients with recently diagnosed glioblastoma.
Glioblastoma is the most common malignant primary brain tumour accounting for approximately half of all malignant primary brain tumours. There are approximately 2,200 new cases diagnosed annually in England. Glioblastoma is highly infiltrative and rapidly progressive. Data from national databases describes survival of patients with newly diagnosed glioblastoma of only 6-10 months. Novel treatment interventions are needed urgently to improve clinical outcomes for patients with glioblastoma. Improvements in clinical outcomes with immunotherapies in other advanced tumours ( melanoma, non-small cell lung cancer, and renal cell carcinoma) has led to the investigation of immunotherapies in a wide number of cancers and settings.
The standard treatment for glioblastoma is to have surgery, which may have been a subtotal resection or gross total resection (more extensive removal of the tumour). Following surgical recovery, patients have 6 weeks of radiotherapy and chemotherapy (drug) called temozolomide. We are trying to find out whether after chemoradiotherapy it is better to continue with standard treatment, or if adding a drug called ipilimumab to standard treatment is better. Ipilimumab is an immunotherapy.
Patients with newly diagnosed glioblastoma following surgery and chemoradiotherapy with temozolomide will be recruited from 5-7 hospitals in the UK. Patients who meet the eligibility criteria will be randomly allocated in a 2:1 ratio to receive either Arm A (ipilimumab + temozolomide, 80 patients) or Arm B (temozolomide alone, 40 patients). The duration of study treatment is 24 weeks and the end of study visit is at 52 weeks. Survival data and other information relevant to survival will be collected from medical records at 18 months from the last participant's randomisation and 2, 3, and 5 years from individual participant randomisation dates.Summary of Results:
The main aim of this trial was to find out whether people with glioblastoma (a type of brain tumour) were helped by adding ipilimumab (a type of targeted drug called a monoclonal antibody) to the usual treatment for this cancer.Glioblastoma is one of the most common types of brain tumour in adults. The usual treatment for people with a newly diagnosed glioblastoma is surgery to remove some or all of the tumour followed by radiotherapy and a drug called temozolomide (this combination is called chemoradiotherapy). Then temozolomide is given alone for up to 6 months (this is called adjuvant treatment).
Glioblastomas can come back or continue to grow despite this usual treatment. In this trial, doctors wanted to find out whether ipilimumab can help to stop glioblastomas from coming back.
Ipilimumab works by stimulating certain immune cells called T-cells to find and attack the cancer. Ipilimumab is already a treatment for a number of different cancer types.
119 people took part in the trial. Before the trial, they had surgery to remove all or part of their tumour, and then 6 weeks of standard chemoradiotherapy. Next, when they joined the trial:
• 40 people were randomly selected to receive temozolomide (the usual treatment) for five days, every 28 days, for up to 6 months.
• 79 people were randomly selected to receive temozolomide (as above) plus ipilimumab every 3 weeks, for up to 4 treatments.The trial found no evidence of a difference between the life expectancy of people in the two groups following treatment. The addition of ipilimumab to usual treatment did not show a beneficial effect. It is not recommended that ipilimumab is used in combination with temozolomide to treat glioblastoma. No further trials are planned.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0525
Date of REC Opinion
2 Nov 2018
REC opinion
Further Information Favourable Opinion