GVAX + Checkpoint Inhibitors for Neuroblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Natalie B. Collins, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for children over 1 year old with high-risk neuroblastoma, who can undergo surgery at Boston Children's Hospital. They must have recovered from previous cancer treatments and meet specific blood, liver, kidney, and lung function criteria. Pregnant women are excluded, as well as those with certain immune conditions or recent steroid therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Tissue Collection and Vaccine Preparation
Participants undergo neuroblastoma cell collection from resected tumor tissue to create the GVAX vaccine
Treatment
Participants receive the GVAX vaccine along with nivolumab and ipilimumab. Vaccine injected weekly over initial 21-day cycle, biweekly for cycles 2-4, and cycles 5 and subsequent of 28-day cycle duration until vaccine supply is exhausted. Intravenous infusion of nivolumab and ipilimumab every 3 weeks for cycles 1-4, and nivolumab biweekly for cycle 5 and subsequent.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GVAX Vaccine
- Ipilimumab
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor