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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:4/4/2019
Start Date:July 2014
End Date:January 2023
Contact:JOSEMUND MENEZES
Email:clinicaltrials@tessatherapeutics.com
Phone:65 6384 0755

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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

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 lymphocytes (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 lymphocytes 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".

330 patients will be randomized after their eligibility status has been fully determined and
informed consent has been obtained. Patients will be randomly allocated to receive either Arm
A (Gemcitabine and Carboplatin (GC) x 4 cycles and EBV-specific CTL) or Arm B (GC x 6 cycles
alone) in a 1:1 ratio using a stratified block randomization scheme. The stratification
variables are country and disease stage (metastatic vs locally recurrent)

After randomization, patients in Arm A will have their peripheral blood taken for the
establishment of cytotoxic T cell line and EBV transformed lymphoblastoid cell line (CTL).
Within two weeks of enrollment, patients will commence combination GC chemotherapy for a
total of 4 cycles. Patients in Stage 2 of study will receive the EBV-specific CTL
immunotherapy.

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
surgery

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

2. Radiologically measurable disease

3. Human Immunodeficiency Virus (HIV) negative*

* Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests
available within 12 months before screening or at 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
≥100,000/mm3

8. Male or female

9. Age ≥21 years

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 12 months before screening or at 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
screening

11. Prior chemotherapy for metastatic or locally recurrent disease

Exceptions:

- Prior radiotherapy with curative intent

- Prior chemo-radiotherapy with curative intent

- Adjuvant chemotherapy

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

12. Severe intercurrent infections

13. Prior immunotherapy for metastatic or locally recurrent disease

Exception:

• Adjuvant immunotherapy/ biologics
We found this trial at
8
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Lori J Wirth, MD
Phone: 617-724-9190
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Premal Lulla, MBBS
Phone: 832-824-4594
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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660 Hall Street
Dallas, Texas 75246
Principal Investigator: Eric S Nadler, MD
Phone: 214-820-5424
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Erminia Massarelli, MD
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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George Town, Penang
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2315 Stockton Boulevard
Sacramento, California 95817
Principal Investigator: Mehrdad Abedi, MD
Phone: 916-734-0561
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505 Parnassus Avenue
San Francisco, California 94143
Principal Investigator: Alain Algazi, MD
Phone: 415-502-3569
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Stanford, California 94305
Principal Investigator: Dimitrios A. Colevas, MD
Phone: 650-721-6509
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