NCT04239040

GVAX Plus Checkpoint Blockade in Neuroblastoma

A Phase 1 Study of Combination Nivolumab and Ipilimumab With Irradiated GM-CSF Secreting Autologous Neuroblastoma Cell Vaccine (GVAX) for Relapsed or Refractory Neuroblastoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This research clinical trial is studying the creation and administration of GVAX, an irradiated GM-CSF secreting, autologous neuroblastoma cell vaccine (GVAX) in combination with nivolumab and ipilimumab as a possible treatment for neuroblastoma. The names of the study drugs involved in this study are: * GVAX Vaccine, an immunotherapy developed from surgically removed tumor tissue * Nivolumab * Ipilimumab

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved the GVAX vaccine as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has not approved nivolumab or ipilimumab for your specific disease but it has been approved for other uses. The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. This phase 1 study will be conducted in 2 parts * In the first part, participants will, as part of standard of care procedure to remove cancerous tissue, undergo neuroblastoma cell collection from a portion of resected tumor. * Those cells will then be used to create the vaccine which will be stored for potential use during the second part of this research study. * In the second part, participants who did not respond to standard therapy will receive the GVAX vaccine along with nivolumab and ipilimumab. The study treatment will continue for up to 24 months and participants will be followed for 2 years after last study treatment (if received at least one vaccination).

Conditions

• Neuroblastoma
• Pediatric Solid Tumor

Interventions

Type	Name	Description
PROCEDURE	Tissue collection	Collection of cancerous tissue to create GVAX vaccine or irradiated GMCSF-secreting autologous neuroblastoma cell vaccine at time of clinically indicated surgical procedure
BIOLOGICAL	GVAX vaccine	Vaccine injected weekly over initial 21 day cycle, biweekly for cycles 2-4 of 21 day cycle duration and cycles 5 and subsequent of 28 day cycle duration until vaccine supply is exhausted.
DRUG	Nivolumab	Intravenous infusion of nivolumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days Intravenous infusion of nivolumab biweekly for cycle 5 and subsequent of 28 day cycle duration. Subsequent 28 day cycles will last up to 2 years.
DRUG	Ipilimumab	Intravenous infusion of ipilimumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days

Timeline

• Start date: 2020-01-29
• Primary completion: 2024-01-27
• Completion: 2024-02-29
• First posted: 2020-01-23
• Last updated: 2025-03-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study