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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 is a Phase 3 study that has completed, run by Tessa Therapeutics. The registered enrollment target is 330 participants.
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".
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02578641
The ClinicalTrials.gov registry entry for NCT02578641 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tessa Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which autologous EBV specific Cytotoxic T cells is the first listed.
NCT02578641 reports 0 study locations.
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.
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