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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 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 13 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04624113
The ClinicalTrials.gov registry entry for NCT04624113 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04624113 reports 0 study locations.
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.
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