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NCT04831320 · ClinicalTrials.gov registry record · Phase 2
Nab-Paclitaxel in Combination With Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma That Progressed on a PD-1 or PD-L1 Inhibitor
A Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT04831320 is a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 46 participants, below the 125-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04831320, a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary hypothesis is that the objective response rate (ORR) with nab-paclitaxel and nivolumab will be significantly higher than the historical control (ORR 30%). The KEY secondary hypothesis is that the median PFS with nab-paclitaxel and nivolumab will be significantly longer than the historical control (median PFS 3.6 months).
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG nab-paclitaxel
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-09-28 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04831320
The ClinicalTrials.gov registry entry for NCT04831320 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 125-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (63% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT04831320 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT04831320 about?
NCT04831320 is a clinical study titled "Nab-Paclitaxel in Combination With Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma That Progressed on a PD-1 or PD-L1 Inhibitor". The primary hypothesis is that the objective response rate (ORR) with nab-paclitaxel and nivolumab will be significantly higher than the historical control (ORR 30%). The KEY secondary hypothesis is that the median PFS with nab-paclitaxel and nivolumab will be significantly longer than the historic...
What is the current status of trial NCT04831320?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2021-09-28. Estimated completion is 2027-01-31.
What conditions does trial NCT04831320 study?
This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma.
What interventions are being tested in trial NCT04831320?
The interventions under investigation include: Nivolumab (DRUG), nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04831320?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04831320 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.