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NCT03597282 · ClinicalTrials.gov registry record · Phase 1
A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma
A Phase 1 study, sponsored by BioNTech US.
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT03597282 is a Phase 1 study that was terminated before completion, run by BioNTech US. The registered enrollment target is 22 participants.
The verdict
NCT03597282, a Phase 1 study, was terminated before completion, sponsored by BioNTech US.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma. The study will also investigate an alternative schedule for the administration of the NEO-PV-01 vaccine. Study interventions will be assessed by both clinical and immune responses to treatment.
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL ipilimumab
- BIOLOGICAL NEO-PV-01
- OTHER Adjuvant
- BIOLOGICAL APX005M
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-10-08 |
| Est. Completion | 2020-08-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03597282
The ClinicalTrials.gov registry entry for NCT03597282 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech US, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT03597282 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03597282 about?
NCT03597282 is a clinical study titled "A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma". The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma. The study will also investigate an alternative schedule for the administration of the NEO-PV-01...
What is the current status of trial NCT03597282?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2018-10-08. Estimated completion is 2020-08-11.
What interventions are being tested in trial NCT03597282?
The interventions under investigation include: Nivolumab (BIOLOGICAL), ipilimumab (BIOLOGICAL), NEO-PV-01 (BIOLOGICAL), Adjuvant (OTHER), APX005M (BIOLOGICAL).
Who is sponsoring clinical trial NCT03597282?
This trial is sponsored by BioNTech US, which has 3 total clinical trials registered on ClinicalTrials.gov.
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