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NCT04191421 · ClinicalTrials.gov registry record · Phase 1
Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT04191421: Completed Phase 1 study, sponsored by Emory University.
NCT04191421 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04191421, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This phase Ib/II trial studies the best dose and side effects of siltuximab and how well it works in combination with spartalizumab in treating patients with pancreatic cancer that has spread to other places in the body. Monoclonal antibodies, such as siltuximab and spartalizumab, interfere with the ability of tumors cells to grow and spread.
Primary Outcome
Maximal tolerated dose (MTD )is defined as the dose at which less than one-third of the subjects experience a dose-limiting toxicity (DLT) in the first 6 weeks of treatment. A DLT is defined as an adverse event or abnormal laboratory value assessed as definitely at least possibly related to study treatment treatment related that occurs within the first 6 weeks. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading.
Interventions
- BIOLOGICAL Siltuximab
- BIOLOGICAL Spartalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-01-17 |
| Est. Completion | 2023-04-05 |
| Phase | Phase 1 |
What the finished NCT04191421 record still lists
NCT04191421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Siltuximab is the first listed.
NCT04191421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04191421 about?
NCT04191421 is a clinical study titled "Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer". This phase Ib/II trial studies the best dose and side effects of siltuximab and how well it works in combination with spartalizumab in treating patients with pancreatic cancer that has spread to other places in the body. Monoclonal antibodies, such as siltuximab and spartalizumab, interfere with the...
What is the current status of trial NCT04191421?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2020-01-17. Estimated completion is 2023-04-05.
What interventions are being tested in trial NCT04191421?
The interventions under investigation include: Siltuximab (BIOLOGICAL), Spartalizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04191421?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04191421's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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