GVAX + Checkpoint Inhibitors for Neuroblastoma

Recruiting at 1 trial location

Overseen By Natalie B Collins, MD, PHD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Systemic corticosteroids, Antiretrovirals

Disqualifiers: Brain metastases, Immunodeficiency, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

19 Participants Needed

Trial Summary

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

Research Team

Natalie B. Collins, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

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.

Treatment Details

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.

Participant Groups

Group I: Relapsed or Refractory High Risk Neuroblastoma Experimental Treatment 4 Interventions

Tissue Collection of Cancerous cells during primary or clinically indicated surgical resection. Manufacture and cryopreservation of vaccine. Treatment with vaccine, nivolumab and ipilimumab. * 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. * Intravenous infusion of nivolumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days * Intravenous infusion of ipilimumab 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+