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GVAX Plus Checkpoint Blockade in Neuroblastoma

NCT04239040 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-03-19

No results posted yet for this study

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

Conditions

Interventions

PROCEDURE

Tissue collection

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

BIOLOGICAL

GVAX vaccine

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.

DRUG

Nivolumab

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.

DRUG

Ipilimumab

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

Sponsors & Collaborators

Principal Investigators

  • Natalie B Collins, MD, PHD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2024-01-27
Completion
2024-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04239040 on ClinicalTrials.gov