19 Participants Needed
Dana-Farber Cancer Institute logo

GVAX + Checkpoint Inhibitors for Neuroblastoma

Recruiting at 1 trial location
NB
Overseen ByNatalie B Collins, MD, PHD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

NB

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

I, or my guardian, can understand and sign the consent form.
I can do most activities but need help with some.
My liver is working well.
See 38 more

Exclusion Criteria

I am not on high-dose steroids, except for adrenal insufficiency or as premedication.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to GM-CSF or DMSO.
I do not have any serious illnesses that are not under control.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tissue Collection and Vaccine Preparation

Participants undergo neuroblastoma cell collection from resected tumor tissue to create the GVAX vaccine

3-4 weeks

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.

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • GVAX Vaccine
  • Ipilimumab
  • Nivolumab
Trial Overview The study tests a vaccine called GVAX made from the patient's own tumor cells combined with nivolumab and ipilimumab immunotherapies. It aims to treat neuroblastoma by helping the body's immune system recognize and fight cancer cells.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Relapsed or Refractory High Risk NeuroblastomaExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
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Recruited
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