A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients
Completed · Phase 3
Conditions studied: Nasopharyngeal Carcinoma
In brief
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".
Key facts
- Study ID
- NCT02578641
- Run by
- Tessa Therapeutics
- People needed
- 330
- Starts
- 2014-07-01
- Expected to finish
- 2022-02-28
- Last updated by the study team
- 2023-06-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- University of California Davis Health — Sacramento, California, United States
- UCSF HDF Comprehensive Cancer Center — San Francisco, California, United States
- Stanford Cancer Center — Stanford, California, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Baylor Scott & White — Dallas, Texas, United States
- Baylor College of Medicine — Houston, Texas, United States
- Site MY-03 — George Town, Pulau Pinang, Malaysia
- Site MY-06 — George Town, Pulau Pinang, Malaysia
- Site MY-07 — Johor Bahru, Malaysia
- Site MY-01 — Kuala Lumpur, Malaysia
- Site MY-04 — Kuala Lumpur, Malaysia
- Site MY-05 — Kuala Lumpur, Malaysia
- Site MY-08 — Kuala Lumpur, Malaysia
- Site SG-11 — Singapore, Singapore
- Site SG-12 — Singapore, Singapore
- Changhua Christian Hospital — Changhua, Taiwan
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
- China Medical University Hospital — Taichung, Taiwan
- Taichung Veterans General Hospital — Taichung, Taiwan
- National Taiwan University Hospital — Taipei, Taiwan
- Taipei Veterans General Hospital — Taipei, Taiwan
- Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan
- Site TH-42 — Bangkok, Thailand
- Site TH-43 — Bangkok, Thailand
Full record on ClinicalTrials.gov
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