EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent/Metastatic Nasopharyngeal… (NCT07138989) | Clinical Trial Compass
Not Yet RecruitingPhase 2
EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent/Metastatic Nasopharyngeal Carcinoma
China10 participantsStarted 2025-08-19
Plain-language summary
Nearly all undifferentiated nasopharyngeal carcinoma (NPC) are associated with the Epstein-Barr Virus (EBV), which typically remains in a latent, non-immunogenic state within tumor cells. By combining EBV lytic induction strategy with standard chemo-immunotherapy, this study aims to create a synergistic anti-tumor effect and improve clinical outcomes for patients with recurrent/metastatic NPC (r/m NPC). This is a phase II, single-center, single-arm clinical trial designed to evaluate the efficacy and safety of a novel combination therapy in patients with r/m EBV-positive NPC.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patients must voluntarily participate and provide written informed consent.
* Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) at enrollment, with positive EBERs by pathological immunohistochemistry.
* Metastatic NPC includes both newly diagnosed metastatic disease and metastatic disease after failure of first-line therapy, as well as recurrent NPC not amenable to local regional treatment, with confirmed metastatic or recurrent disease and no prior treatment after diagnosis.
* Age ≥ 18 years and ≤ 75 years, of any sex.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Expected survival time ≥ 3 months.
* Baseline plasma EBV DNA \> 0 copies/mL.
* Adequate organ function confirmed by the following criteria (no blood component transfusions or use of hematopoietic growth factors within 2 weeks prior to study treatment initiation):
* Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; platelet count ≥ 100 × 10\^9/L; hemoglobin ≥ 90 g/L. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (CrCl) ≥ 60 mL/min . Total bilirubin (TBil) ≤ 1.5 × ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (for patients with liver metastases, TBil ≤ 3 × ULN; AST and ALT ≤ 5 × ULN). Serum albumin ≥ 28 g/L.
Exclusion Criteria:
* History of severe hypersensitivity reactions to other monoclonal antibodies or to any component of PD-1 inhibitor…
What they're measuring
1
Objective Response Rate, ORR
Timeframe: From enrollment to the end of treatment. Up to 2 approximately years.