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NCT04624113 · ClinicalTrials.gov registry record · Phase 1
Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT04624113: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT04624113 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04624113, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary aim of the phase 1 portion of the trial is to establish the recommended phase 2 dose (RP2D) of tazemetostat in combination with a fixed dose of pembrolizumab in patients with recurrent or metastatic (RM) head and neck cancer. The primary aim of the phase 2 portion of the trial is to establish the proportion of patients with pembrolizumab- or nivolumab-resistant, PD-L1 positive, RM head and neck squamous-cell carcinoma (HNSCC) who achieve an objective tumor response to tazemetostat and pembrolizumab.
Interventions
- DRUG Pembrolizumab
- DRUG Tazemetostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2024-02-17 |
| Phase | Phase 1 |
Why NCT04624113 stopped before completion
NCT04624113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04624113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04624113 about?
NCT04624113 is a clinical study titled "Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma". The primary aim of the phase 1 portion of the trial is to establish the recommended phase 2 dose (RP2D) of tazemetostat in combination with a fixed dose of pembrolizumab in patients with recurrent or metastatic (RM) head and neck cancer. The primary aim of the phase 2 portion of the trial is to est...
What is the current status of trial NCT04624113?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-04-14. Estimated completion is 2024-02-17.
What interventions are being tested in trial NCT04624113?
The interventions under investigation include: Pembrolizumab (DRUG), Tazemetostat (DRUG).
Who is sponsoring clinical trial NCT04624113?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04624113's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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