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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: Clinical Trial Phase 1 study, sponsored by BioNTech US.
NCT03597282 is a Phase 1 study that was terminated before completion, run by BioNTech US. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Rate of adverse events and severe adverse events leading to treatment discontinuation and those adverse events and severe adverse events detected during symptom-directed physical examinations (changes in safety laboratory evaluations, physical examination findings. vital signs, and ECOG PS)
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 |
Why NCT03597282 stopped before completion
NCT03597282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT03597282 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03597282's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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