GVAX Plus Checkpoint Blockade in Neuroblastoma

Neuroblastoma Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial 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

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Neuroblastoma
• Pediatric Solid Tumor

• NCT number: NCT04239040
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 29, 2020
• Completion date: January 1, 2027