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NCT03953235 · ClinicalTrials.gov registry record · Phase 1
A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens
A Phase 1 study, sponsored by Gritstone bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT03953235 is a Phase 1 study that has completed, run by Gritstone bio. The registered enrollment target is 39 participants.
The verdict
NCT03953235, a Phase 1 study, has completed, sponsored by Gritstone bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors. Based on the Phase 1 data, an updated vaccine candidate (SLATE-KRAS or version 2) was developed that removed 16 of the 20 mutations included in the original vaccine (version 1) and solely targets KRAS mutations.
Interventions
- BIOLOGICAL nivolumab
- BIOLOGICAL ipilimumab
- BIOLOGICAL GRT-C903
- BIOLOGICAL GRT-R904
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2023-03-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03953235
The ClinicalTrials.gov registry entry for NCT03953235 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gritstone bio, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which nivolumab is the first listed.
NCT03953235 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03953235 about?
NCT03953235 is a clinical study titled "A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens". The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsate...
What is the current status of trial NCT03953235?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2019-07-18. Estimated completion is 2023-03-10.
What interventions are being tested in trial NCT03953235?
The interventions under investigation include: nivolumab (BIOLOGICAL), ipilimumab (BIOLOGICAL), GRT-C903 (BIOLOGICAL), GRT-R904 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03953235?
This trial is sponsored by Gritstone bio, which has 4 total clinical trials registered on ClinicalTrials.gov.
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