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A Phase 2b Clinical Study W/ a Combination Immunotherapy in Newly Diagnosed Patients W/ Glioblastoma

The purpose of this study is to see how safe the investigational study drug is - either IGV-001 (study drug) plus standard of care (SOC) or placebo plus SOC - and to see if it works in slowing GBM tumor regrowth. SOC treatment for this study refers to temozolomide and radiotherapy used to treat your cancer.

Age & Gender

  • 18 years ~ 70 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

At each visit, you will meet with a member of the study team and fill out questionnaires. The study involves blood collection for research purposes in addition to routine blood work, you will have an electrocardiogram (ECG), and magnetic resonance imaging (MRI) scan to confirm the cancer status in your body. During screening you will also have surgery to remove your brain tumor (called a craniotomy and tumor resection to confirm your diagnosis is malignant glioma, perform gene testing and to make the study immunotherapy (IGV-001). For treatment you will have a surgical procedure where the study doctor will insert the biodiffusion chambers into your belly area, which will be removed by a surgical procedure on day 3. After the biodiffusion chamber has been removed you will be prescribed a steroid medicine. Around week seven you will begin the standard of care (SOC) treatment period, the SOC will be a combination of radiation therapy (also called radiotherapy) and temozolomide. During this period, you will need to come to the study clinic 5 days per week for 6 weeks to receive your radiotherapy while taking temozolomide daily. About 4 weeks after your last treatment of radiotherapy, you will begin taking temozolomide on Days 1 through 5 of 28-day cycles, for a total of 6 cycles (or about 24 weeks). During the SOC Treatment Period, you will also need to visit the study clinic once per month.

Incentives

Study Medication, $50 VISA pre-paid debit card for you to use for incidentals during study visits

Total length of participation:
36 months

Looking for Specific Volunteers

Able to participate:

  • Have a diagnosis of malignant glioma.
  • The tumor must be located in the upper part of the brain (supratentorial compartment).
  • Have healthy organ function.

Not eligible if:

  • Have a bi-hemispheric disease, multicentric disease, or disease burden involving the brain stem or cerebellum.
  • Have received any previous surgical resection or any anticancer intervention for GBM.
  • Have recurrent glioma, a concurrent malignancy, or malignancy within 3 years.
  • Have any severe immunocompromised condition or any active uncontrolled autoimmune disorder (eg, Crohn's disease).
  • Have an active cardiac disease or a history of cardiac dysfunction.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Soma Sengupta
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Brain and Other Nervous System)

IRB Number

23-1597

ClinicalTrials.gov

NCT04485949

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