A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients

Not Recruiting

Trial ID: NCT02578641


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".

Official Title

A Multicentre, Randomized, Open-Label, Phase III Clinical Trial Of Gemcitabine And Carboplatin Followed By Epstein-Barr Virus-Specific Autologous Cytotoxic T Lymphocytes Versus Gemcitabine And Carboplatin As First Line Treatment For Advanced Nasopharyngeal Carcinoma(NPC) Patients

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


Key Inclusion Criteria

   1. Metastatic or locally recurrent EBV-positive, non-keratinizing and/ or
   undifferentiated NPC* who do not have curative options such as chemo-radiation or

   *Subjects will be enrolled based on confirmed histology diagnosis of the NPC

   2. Radiologically measurable disease as per RECIST 1.1

   3. Human Immunodeficiency Virus (HIV) negative*

   * Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests
   available within 4 weeks of screening

   4. Bilirubin <2 x upper limit of normal (ULN) and aspartate aminotransferase (AST),
   alanine aminotransferase (ALT) <3 x ULN

   5. Calculated creatinine clearance (CRCL) ≥40 mL/min. Glomerular Filtration Rate (GFR) is
   calculated based on Cockcroft-Gault method.

   6. Normal corrected calcium levels

   7. Absolute neutrophil count >1200/mm3, hemoglobin (Hb) ≥10 g/dL and platelets

   8. Male or female

   9. Age ≥ 18 years or according to local legal age of consent

10. Eastern Cooperative Oncology Group Performance Scale (ECOG-PS) ≤2

11. Written informed consent

12. Life expectancy >6 months

Key Exclusion Criteria

   1. Severe concomitant illness i.e. chronic obstructive pulmonary disease (COPD), ischemic
   heart disease (IHD), active congestive cardiac failure (CCF), active angina pectoris,
   uncontrolled arrhythmia, uncontrolled hypertension

   2. HIV Positive*

   * Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests
   available within 4 weeks of screening

   3. Pregnant or lactating females

   4. Refuse of use of contraception during trial (both male and female patients)

   5. Investigational therapy less than one month prior to study entry

   6. Pre-existing peripheral neuropathy (National Cancer Institute Common Terminology
   Criteria for Adverse Events [NCI CTCAE] ≥2)

   7. Central nervous system metastasis

   8. Previous or concurrent cancer that is distinct in primary site or histology from the
   cancer being evaluated in this study, EXCEPT cervical carcinoma in situ, treated basal
   cell carcinoma, superficial bladder tumors [Ta, Tis and T1] or any cancer curatively
   treated >3 years prior to study entry

   9. Positive hepatitis B surface antigen (HBsAg) results

10. Known history of hepatitis C and recovery status has not been determined at time of

11. Prior anti-cancer treatment for metastatic or locally recurrent disease, EXCEPT:

   For metastatic or locally recurrent disease, localised palliative radiotherapy is

   For locally recurrent disease, the following treatment is allowed

      - Prior radiotherapy with curative intent

      - Prior chemo-radiotherapy with curative intent

      - Adjuvant chemotherapy

      - Localised palliative radiotherapy Prior chemotherapy must be > 6 months before

12. Severe intercurrent infections

13. Prior immunotherapy for metastatic or locally recurrent disease

The following is allowable:

• Adjuvant immunotherapy/ biologics Prior adjuvant immunotherapy/ biologics must be > 6
months before screening


drug: combination IV gemcitabine and IV carboplatin (AUC2)

biological: autologous EBV specific Cytotoxic T cells

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Winters

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