12 Years and up
Accepting Healthy Volunteers?
1. Male or female ≥ 12 years of age
2. Incurable, locally recurrent or metastatic EBV+NPC (World Health Organization type
3. Subjects must have had prior receipt of platinum-containing regimen
4. Phase 1B (Cohort 1):
1. Checkpoint inhibitor naïve (have never received pembrolizumab or any other
checkpoint/immuno-oncology agents) OR
2. Refractory to an anti-programmed cell death protein-1 (PD-1) or anti-programmed
death-ligand1 (PD-L1) monoclonal antibody approved by the local regulatory agency
either as monotherapy or in combination with other checkpoint inhibitors or
therapies according to their approved label.
5. Phase 2 (Cohort 2): Checkpoint inhibitor naïve (have never received pembrolizumab or
any other checkpoint/immuno-oncology agents
6. Life expectancy ≥ 4 months at time of screening
7. Measurable disease using RECIST 1.1. Tumor lesions situated in a previously irradiated
area are considered measurable if progression has been documented in such lesions
8. Eastern Cooperative Oncology Group (ECOG) performance status of < 2 for subjects aged
> 16 years; Lansky score ≥ 70 for subjects aged 12 to 16 years
9. Adequate organ function per the protocol.
10. Willing and able to provide written informed consent (pediatric subjects 12 to < 18
years of age must provide assent along with consent from the subject's legally
1. Disease that is suitable for local therapy administered with curative intent
2. Requires vasopressor or ventilator support
3. Received antithymocyte globulin or similar anti-T-cell antibody therapy ≤ 4 weeks
prior to Cycle 1 Day 1
4. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
form of immunosuppressive therapy within 7 days prior to Cycle 1 Day 1 of study
5. Active autoimmune disease that has required systemic treatment in past 2 years (ie,
with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement
therapy for adrenal or pituitary insufficiency) is not considered a form of systemic
treatment and is allowed.
6. History or evidence of interstitial lung disease
7. History of severe hypersensitivity (Grade ≥ 3) to pembrolizumab and/or any of its
8. Active infection requiring systemic therapy
9. History of (non-infectious) pneumonitis that required steroids or current pneumonitis
10. Received transfusion of blood products (including platelets or red blood cells) or
administration of colony stimulating factors (including granulocyte-colony stimulating
factor, granulocyte macrophage-colony stimulating factor or recombinant erythropoetin)
within 4 weeks prior to study Day 1
11. Received any non-oncology vaccine therapy used for prevention of infectious diseases
for up to 30 days prior to enrollment.
12. Known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
skin that has undergone potentially curative therapy or in situ cervical cancer
13. Pregnancy or breastfeeding: females of childbearing potential must have a negative
serum pregnancy test.
14. Female of childbearing potential or male with a female partner of childbearing
potential unwilling to use a highly effective method of contraception (abstinence is
acceptable) for the course of the study through 120 days after the last study dose
15. Inability to comply with study procedures
16. Received chemotherapy or targeted small molecule therapy within 2 weeks of Cycle 1 Day
1. Subjects must have recovered (ie, grade ≤ 1 or at baseline) from AEs due to a
previously administered agent. Subjects with grade ≤ 2 neuropathy or grade ≤ 2
alopecia are an exception to this criterion.
17. Received prior radiotherapy within 2 weeks of Cycle 1 Day 1. Subjects must have
recovered from all radiation-related toxicities, not require corticosteroids, and not
have had radiation pneumonitis. A 1- week washout is permitted for palliative
radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
18. Antibody/biologic therapy within 4 weeks of Cycle 1 Day 1 or not recovered (i.e.,
grade ≤ 1 or at baseline) from AEs due to agents administered more than 4 weeks
19. Carcinomatous meningitis; and/or active CNS metastases, unless metastases are treated
and stable and the subject does not require systemic steroids.
20. Known history of human immunodeficiency virus (HIV), known active hepatitis B virus
(HBV; e.g., hepatitis B surface antigen [HBsAg] reactive), or hepatitis C virus (HCV;
e.g., HCV ribonucleic acid [RNA] is detected)
21. Prior treatment with any investigational product within 4 weeks of Cycle 1 Day 1
22. Prior treatment with EBV T cells