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NCT03406715 · ClinicalTrials.gov registry record · Phase 2
Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC)
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT03406715: Clinical Trial Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03406715 is a Phase 2 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03406715, a Phase 2 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to find out what effects (good and bad) immunotherapy treatment using the p53 vaccine (Ad.p53-DC) in combination with Nivolumab and Ipilimumab has on small cell lung cancer. Immunotherapy is a cancer therapy that uses the body's immune system to fight cancer cells. This study can be divided into three different phases: initial Induction Immunotherapy, Maintenance Immunotherapy and Retreatment.
Primary Outcome
Response will be assessed primarily using the response evaluation criteria in solid tumors (RECIST v1.1). The immune related (ir)RECIST will also be used secondarily. DCR = Complete Response (CR) = Partial Response (PR) + Stable Disease (SD) rates. The disease control (DCR=CR+PR+SD) rates will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by group.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- BIOLOGICAL Dendritic Cell based p53 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2022-05-16 |
| Phase | Phase 2 |
Why NCT03406715 stopped before completion
NCT03406715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03406715 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03406715 about?
NCT03406715 is a clinical study titled "Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC)". The purpose of this study is to find out what effects (good and bad) immunotherapy treatment using the p53 vaccine (Ad.p53-DC) in combination with Nivolumab and Ipilimumab has on small cell lung cancer. Immunotherapy is a cancer therapy that uses the body's immune system to fight cancer cells. This...
What is the current status of trial NCT03406715?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2018-03-15. Estimated completion is 2022-05-16.
What interventions are being tested in trial NCT03406715?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Dendritic Cell based p53 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03406715?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03406715's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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