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NCT03769467 · ClinicalTrials.gov registry record · Phase 1
Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)
A Phase 1 study, sponsored by Atara Biotherapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03769467: Clinical Trial Phase 1 study, sponsored by Atara Biotherapeutics.
NCT03769467 is a Phase 1 study that was terminated before completion, run by Atara Biotherapeutics. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03769467, a Phase 1 study, was terminated before completion, sponsored by Atara Biotherapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, single-arm Phase 1B/2 study to assess the safety and efficacy of tabelecleucel in combination with pembrolizumab for the treatment of subjects with platinum-pretreated, recurrent/metastatic Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC).
Primary Outcome
The occurrence of any of the following toxicities during Treatment Cycle 1 will be considered a DLT, if assessed by the investigator to be possibly related or related to investigational product administration (either tabelecleucel and/or pembrolizumab): Grade (G) 4 nonhematologic toxicity; G4 hematologic toxicity lasting \>=7 days, except thrombocytopenia; any nonhematologic AE \>=G3, except G3 fatigue lasting =\<3 days; G3 diarrhea, nausea, or vomiting; G3 rash; Any G3/4 non-hematologic laborat
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Tabelecleucel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-02-19 |
| Est. Completion | 2021-08-19 |
| Phase | Phase 1 |
Why NCT03769467 stopped before completion
NCT03769467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03769467 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03769467 about?
NCT03769467 is a clinical study titled "Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)". This is a multicenter, open-label, single-arm Phase 1B/2 study to assess the safety and efficacy of tabelecleucel in combination with pembrolizumab for the treatment of subjects with platinum-pretreated, recurrent/metastatic Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC).
What is the current status of trial NCT03769467?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-02-19. Estimated completion is 2021-08-19.
What interventions are being tested in trial NCT03769467?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Tabelecleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT03769467?
This trial is sponsored by Atara Biotherapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03769467's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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