Nivolumab + Temozolomide for Glioblastoma
(NUTMEG Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it excludes those needing high doses of certain steroids or immunosuppressive drugs. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Nivolumab and Temozolomide for treating glioblastoma?
Research shows that Temozolomide is effective in treating various types of brain tumors, including glioblastoma, and is often used in combination with other treatments to improve outcomes. Additionally, Nivolumab has been studied in combination with radiotherapy and Temozolomide, showing potential benefits in newly diagnosed glioblastoma patients.12345
What safety information is available for the combination of Nivolumab and Temozolomide in humans?
Temozolomide, used for brain cancers like glioblastoma, commonly causes mild to moderate side effects such as fatigue, nausea, and low blood cell counts. Severe blood-related side effects are rare but can include conditions like aplastic anemia. Safety data for Nivolumab in combination with Temozolomide specifically is limited, but Temozolomide alone has been generally well-tolerated in humans.12367
How is the drug Nivolumab + Temozolomide unique for treating glioblastoma?
Nivolumab + Temozolomide is unique because it combines an immune checkpoint inhibitor (Nivolumab) with a chemotherapy drug (Temozolomide) to potentially enhance the immune system's ability to fight glioblastoma, a type of brain cancer. This combination aims to improve outcomes compared to standard treatments, which often involve only Temozolomide and radiotherapy.258910
What is the purpose of this trial?
This study aims to investigate effect of Nivolumab and Temozolomide vs Temozolomide alone on overall survival in newly diagnosed elderly patients with glioblastoma.Who is it for? You may be eligible to join this study if you are aged 65 years or above, with newly diagnosed histologically confirmed GBM (WHO grade IV glioma including gliosarcoma) following surgery.The study aims to evaluate whether the combination of adjuvant nivolumab with temozolomide improves overall survival outcomes for this patient population. The outcome of the study will help determine the most effective treatment for patients with glioblastoma in the future.
Research Team
Mustafa Khasraw
Principal Investigator
Duke University
Eligibility Criteria
Elderly patients aged 65 or above with newly diagnosed glioblastoma (GBM) may qualify for this trial. They should have had surgery, a life expectancy over 12 weeks, and be able to undergo MRI scans. Excluded are those needing high doses of steroids, with certain autoimmune diseases or other serious health issues that could affect the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiotherapy
Participants receive standard radiotherapy treatment (40 Gy administered in 15 fractions)
Treatment
Participants receive either Nivolumab with Temozolomide or Temozolomide alone after a 4-week break post-radiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nivolumab
- Temozolomide
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Sydney
Lead Sponsor
Cooperative Trials Group for Neuro-Oncology
Collaborator