Clinical Trial - NCT02578641

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

Recruiting

Sponsor: Tessa Therapeutics

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02578641

Protocol Info

Short Description: Phase III Gem + Carbo + Autologous EBV-specific CTL in Nasopharyngeal Carcinoma
Long Description: A Multicentre, Randomized, Open-label, Phase III Clinical Trial of Gemcitabine and Carboplatin followed by Epstein-Barr Virusspecific Autologous Cytotoxic T Lymphocytes versus Gemcitabine and Carboplatin as First Line Treatment for Advanced Nasopharyngeal Carcinoma Patients
MGH Status: Open
Sponsor: Tessa Therapeutics Pte. Ltd.
Disease Program: Cellular

Next Steps


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Purpose

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".
Condition Title Intervention Phase
Nasopharyngeal Carcinoma autologous EBV specific Cytotoxic T Lymphocytes combination IV gemcitabine and IV carboplatin (AUC Phase 3
Study Type Interventional
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

Primary Outcome Measures

Prolonging Overall Survival [Time Frame: through study completion, an average of 1 year] [Designated as safety issue: ]


Secondary Outcome Measures

Disease Progression [Time Frame: through study completion, an average of 1 year] [Designated as safety issue: ]

Overall Response Rate [Time Frame: through study completion, an average of 1 year] [Designated as safety issue: ]

Clinical Benefit Rate [Time Frame: through study completion, an average of 1 year] [Designated as safety issue: ]

Quality of Life of patients [Time Frame: through study completion, an average of 1 year] [Designated as safety issue: ]

Estimated Enrollment: 330
Study Start Date: July 2014
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: December 2020
Arms Assigned Interventions

Experimental:Arm A

4 cycles of combination IV Gemcitabine (1000 mg/m2) and IV carboplatin (AUC2) on Days 1, 8, 15 every 28 days, followed sequentially by T-cell immunotherapy (2 cycles) of autologous EBV specific Cytotoxic T Lymphocytes every 2 weeks, followed by EBV-specific CTL immunotherapy (4 cycles) every 8 weeks after 6 weeks from the second cycle.
Drug:combination IV gemcitabine and IV carboplatin (AUC2)
4 cycles for Arm A and 6 cycles for Arm B

Active Comparator:Arm B

6 cycles of combination IV gemcitabine (1000 mg/m2) and IV carboplatin (AUC2) on Days 1, 8, 15 every 28 days.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02578641

Locations

  • United States, California
    • City of Hope National Medical Center Duarte, California, United States, 91010
    • University of California Davis Health Sacramento, California, United States, 95817
    • UCSF HDF Comprehensive Cancer Center San Francisco, California, United States, 94143
    • Stanford Cancer Center Stanford, California, United States, 94305
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02215
  • United States, Texas
    • Baylor Scott & White Dallas, Texas, United States, 75204
    • Baylor College of Medicine Houston, Texas, United States, 77030
  • Malaysia, Penang
    • Site MY-03 George Town, Penang, Malaysia,
    • Site MY-06 George Town, Penang, Malaysia,
  • 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,
  • Singapore,
    • Site SG-11 Singapore, , Singapore,
    • Site SG-12 Singapore, , Singapore,
  • Taiwan,
    • Changhua Christian Hospital Changhua, , Taiwan,
    • Kaohsiung Chang Gung Memorial Hospital Kaohsiung, , 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,
  • Thailand,
    • Site TH-42 Bangkok, , Thailand,
    • Site TH-43 Bangkok, , Thailand,
    • Site TH-41 Chiang Mai, , Thailand,
    • Site TH-44 Khon Kaen, , Thailand,
    • Site TH-47 Lopburi, , Thailand,
    • Site TH-45 Ubon Ratchathani, , Thailand,
    • Site TH-46 Udon Thani, , Thailand,

Sponsors and Collaborators

Tessa Therapeutics

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02578641
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Tessa Therapeutics:

Nasopharyngeal Carcinoma (NPC)

NPC

immunotherapy

Nasopharyngeal Cancer

Nose Cancer

Cell therapy

Head and Neck Cancer

Cytotoxic T Lymphocytes

chemotherapy

Epstein-Barr Virus

Additional relevant MeSH terms:

Carcinoma

Nasopharyngeal Carcinoma

Gemcitabine

Carboplatin

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on July 18, 2019