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AVeRT: Anti-PD-1 Monoclonal Antibody (Nivolumab) in Combination With DC Vaccines for the Treatment of Recurrent Grade III and Grade IV Brain Tumors (AVERT)
Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab alone and with DC vaccine therapy until surgical resection. During surgical resection blood and tumor samples will be assessed and compared. Following surgery, both groups will continue to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.
Details
| Lead sponsor | Gary Archer Ph.D. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 6 |
| Start date | 2016-01 |
| Completion | 2019-12-30 |
Conditions
- Malignant Glioma
- Astrocytoma
- Glioblastoma
Interventions
- nivolumab
- DC
Primary outcomes
- The Safety of Administering DC Vaccines With Nivolumab — 12 months
The percentage of patients who experience unacceptable toxicity during combination treatment by arm is tabulated. Unacceptable toxicity is defined as any grade 3, 4, or 5 adverse event that is possibly, probably, or definitely related to either nivolumab or DC vaccination treatment during concurrent treatment, or any Grade 2 drug-related uveitis or eye pain or blurred vision that does not respond to topical therapy and does not improve to Grade 1 severity within the re-treatment period OR requires systemic treatment. In addition, any complication following resection (ex. excessive intracranial bleeding, delays in wound healing) that are prolonged longer than 4-6 weeks post-surgery will be considered an unacceptable toxicity.
Countries
United States