GVAX Plus Checkpoint Blockade in Neuroblastoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04239040 |
Recruitment Status :
Active, not recruiting
First Posted : January 23, 2020
Last Update Posted : May 14, 2024
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | January 21, 2020 | ||||||||||||||
First Posted Date ICMJE | January 23, 2020 | ||||||||||||||
Last Update Posted Date | May 14, 2024 | ||||||||||||||
Actual Study Start Date ICMJE | January 29, 2020 | ||||||||||||||
Estimated Primary Completion Date | January 1, 2027 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | GVAX Plus Checkpoint Blockade in Neuroblastoma | ||||||||||||||
Official Title ICMJE | A Phase 1 Study of Combination Nivolumab and Ipilimumab With Irradiated GM-CSF Secreting Autologous Neuroblastoma Cell Vaccine (GVAX) for Relapsed or Refractory Neuroblastoma | ||||||||||||||
Brief 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:
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Detailed Description | 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
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). |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Relapsed or Refractory High Risk Neuroblastoma
Tissue Collection of Cancerous cells during primary or clinically indicated surgical resection. Manufacture and cryopreservation of vaccine. Treatment with vaccine, nivolumab and ipilimumab.
Interventions:
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||
Actual Enrollment ICMJE |
19 | ||||||||||||||
Original Estimated Enrollment ICMJE |
26 | ||||||||||||||
Estimated Study Completion Date ICMJE | January 1, 2027 | ||||||||||||||
Estimated Primary Completion Date | January 1, 2027 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year and older (Child, Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04239040 | ||||||||||||||
Other Study ID Numbers ICMJE | 19-680 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Natalie Collins, MD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Natalie B. Collins, Dana-Farber Cancer Institute, Principal Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | May 2024 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |