103 Participants Needed

Nivolumab + Temozolomide for Glioblastoma

(NUTMEG Trial)

Recruiting at 19 trial locations
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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

MK

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

My liver tests are within normal limits.
I have tissue available for MGMT testing.
My blood tests show my bone marrow is working well.
See 6 more

Exclusion Criteria

I have been cancer-free for 2 years, except for certain skin or in-situ cancers.
I have an autoimmune disease but it's controlled or minor, like type 1 diabetes, mild hypothyroidism, or certain skin conditions.
I need more than 4 mg of dexamethasone or more than 20 mg of prednisone daily for my GBM symptoms.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive standard radiotherapy treatment (40 Gy administered in 15 fractions)

3 weeks

Treatment

Participants receive either Nivolumab with Temozolomide or Temozolomide alone after a 4-week break post-radiotherapy

24 weeks
6 cycles of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

  • Nivolumab
  • Temozolomide
Trial Overview The trial is testing if adding Nivolumab to Temozolomide improves survival in elderly GBM patients compared to using Temozolomide alone after surgery. It's designed to find better treatments for GBM by measuring how long patients live with each therapy.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab and TemozolomideExperimental Treatment2 Interventions
After radiotherapy and 4 week break, participants who are assigned to this arm will receive Nivolumab with concurrent adjuvant temozolomide treatment
Group II: TemozolomideActive Control1 Intervention
After radiotherapy and 4 week break, participants who are assigned to this arm will receive the standard treatment of adjuvant temozolomide treatment

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸
Approved in United States as Opdivo for:
  • 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
🇪🇺
Approved in European Union as Opdivo for:
  • 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
🇨🇦
Approved in Canada as Opdivo for:
  • 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
🇨🇭
Approved in Switzerland as Opdivo for:
  • 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

Trials
208
Recruited
417,000+

Cooperative Trials Group for Neuro-Oncology

Collaborator

Trials
2
Recruited
850+

Findings from Research

Temozolomide is primarily used for treating refractory central nervous system cancers like anaplastic astrocytoma and glioblastoma, but ongoing clinical trials are exploring its efficacy and safety in newly diagnosed gliomas and other types of tumors.
Research is also investigating different dosing schedules and combinations with other treatments, suggesting that temozolomide could be a versatile option in cancer therapy beyond its current approved uses.
Future directions for temozolomide therapy.Yung, WK.[2019]
In a study of 20 patients with various types of glioma, the combination of olaparib and temozolomide (TMZ) showed a 50% objective radiographic response rate in patients with recurrent IDH-mutant grade 2-3 gliomas, indicating potential efficacy for this specific group.
While the treatment was generally manageable, common side effects included fatigue and gastrointestinal issues, with 30% of patients requiring dose adjustments due to toxicity, highlighting the need for careful monitoring during treatment.
Combination Olaparib and Temozolomide for the Treatment of Glioma: A Retrospective Case Series.Schaff, LR., Kushnirsky, M., Lin, AL., et al.[2023]
In a phase II trial involving 46 patients with progressive low-grade glioma, Temozolomide (Temodar) demonstrated a 61% objective response rate, with 24% achieving complete response and 37% achieving partial response.
The treatment showed promising safety, with limited toxicity observed; however, one patient experienced severe complications, highlighting the need for careful monitoring during treatment.
Phase II trial of temozolomide in patients with progressive low-grade glioma.Quinn, JA., Reardon, DA., Friedman, AH., et al.[2022]

References

Future directions for temozolomide therapy. [2019]
Combination Olaparib and Temozolomide for the Treatment of Glioma: A Retrospective Case Series. [2023]
Phase II trial of temozolomide in patients with progressive low-grade glioma. [2022]
Aspirin-/TMZ-coloaded microspheres exert synergistic antiglioma efficacy via inhibition of β-catenin transactivation. [2022]
Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143. [2023]
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]
7.United Arab Emiratespubmed.ncbi.nlm.nih.gov
The safety of the temozolomide in patients with malignant glioma. [2019]
Temozolomide combined with PD-1 Antibody therapy for mouse orthotopic glioma model. [2018]
Combination of a STAT3 Inhibitor and an mTOR Inhibitor Against a Temozolomide-resistant Glioblastoma Cell Line. [2021]
Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. [2023]
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