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NCT02578641 · ClinicalTrials.gov registry record · Phase 3
A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients
A Phase 3 study, sponsored by Tessa Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
NCT02578641: Completed Phase 3 study, sponsored by Tessa Therapeutics.
NCT02578641 is a Phase 3 study that has completed, run by Tessa Therapeutics. The registered enrollment target is 330 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02578641, a Phase 3 study, has completed, sponsored by Tessa Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
Study Summary
This study is a multi-center, randomized, open label, Phase III clinical trial for advanced Nasopharyngeal Carcinoma(NPC) Patients. Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's cytotoxic T cells (CTL) that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T cells may kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with advanced nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3 T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from 30 hospital centers across Asia and the United States. This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38 patients at the National Cancer Centre, Singapore. This trial produced the best published 2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with advanced NPC who received autologous EBV-specific CTL. Kindly see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978790/ for the Phase 2 publication titled "Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or Locally Recurrent Nasopharyngeal Carcinoma".
Primary Outcome
Efficacy of EBV-CTL following first line chemotherapy was compared to chemotherapy alone in terms of OS of subjects with advanced nasopharyngeal carcinoma. Overall survival was defined as the duration in months from the day of randomization until death from any cause for a subject known to be deceased, or censored at the last contact date that a subject was known to be alive or lost to follow-up.
Interventions
- BIOLOGICAL autologous EBV specific Cytotoxic T cells
- DRUG combination IV gemcitabine and IV carboplatin (AUC2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2014-07 |
| Est. Completion | 2022-02-28 |
| Phase | Phase 3 |
What the finished NCT02578641 record still lists
NCT02578641 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which autologous EBV specific Cytotoxic T cells is the first listed.
NCT02578641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02578641 about?
NCT02578641 is a clinical study titled "A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients". This study is a multi-center, randomized, open label, Phase III clinical trial for advanced Nasopharyngeal Carcinoma(NPC) Patients. Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping t...
What is the current status of trial NCT02578641?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2014-07. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT02578641?
The interventions under investigation include: autologous EBV specific Cytotoxic T cells (BIOLOGICAL), combination IV gemcitabine and IV carboplatin (AUC2) (DRUG).
Who is sponsoring clinical trial NCT02578641?
This trial is sponsored by Tessa Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02578641's enrollment target sits among peer trials
330 1066th of 2000 higher than 927 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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