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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: Active Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma, sponsored by Washington University School of Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
* ORR: Proportion of patients who achieve a complete or partial response to treatment * Complete Response (CR): Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
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 |
What the registry record for NCT04831320 still lists
NCT04831320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 125-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (63% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04831320's enrollment target sits among peer trials
46 13th of 24 higher than 11 of 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Head-and-neck Squamous-cell Carcinoma 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.
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