Neoplasms

All Conditions

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Immunomodulating Agents

Nivolumab

Ipilimumab

Immunologic Factors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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.

Collection of cancerous tissue to create GVAX vaccine or irradiated GMCSF-secreting autologous neuroblastoma cell vaccine at time of clinically indicated surgical procedure

Tissue collection

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.

GVAX vaccine

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.

Intravenous infusion of ipilimumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days

Natalie B Collins, MD, PHD

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

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).

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

To assess safety, the number of grade 4 toxicities associated with vaccine and nivolumab/ipilimumab using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5

Feasibility will be assessed by the ability to make vaccine from available biopsy material in quantities sufficient for six vaccinations, for a given patient. A success rate (number of patients for whom quantity sufficient for six vaccinations exist / total number of eligible patients) under 65% may imply that the method needs further development or that the amount of tissue available in this population limits the feasibility of this strategy. Total number of vaccine doses administered per patient will also be counted

Kaplan-Meier plots, 1-year PFS estimate will be calculated, along with the standard errors

Each patient will be categorized as a responder (≥PR) or a non-responder (\<PR) by INRC criteria

Kaplan-Meier plots, 1-year OS estimates will be calculated, along with the standard errors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
GVAX Plus Checkpoint Blockade in Neuroblastoma	NCT04239040	Neuroblastoma Pediatric Solid...	Tissue collecti... GVAX vaccine Nivolumab Ipilimumab	1 Year -	Dana-Farber Cancer Institute
GVAX Plus Checkpoint Blockade in Neuroblastoma	NCT04239040	Neuroblastoma Pediatric Solid...	Tissue collecti... GVAX vaccine Nivolumab Ipilimumab	1 Year -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for gvax vaccine

Every month we try and update this database with for gvax vaccine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.