Bintrafusp Alfa in Previously Treated Patients With Recurrent and Metastatic (R/M) Non-keratinizing Nasopharyngeal Carcinoma (NPC)

# NCT04396886 Trial phase: 2 Study type: immunotherapy

Study Start Date

February, 2020

Scientific Title

Phase II Prospective Study of Bintrafusp Alfa in Previously Treated Patients With Recurrent and Metastatic (R/M) Non-keratinizing Nasopharyngeal Carcinoma (NPC)


This would be a phase II prospective single arm mono-institutional study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of bintrafusp alfa in previously treated patients with recurrent and metastatic (R/M) non-keratinizing nasopharyngeal carcinoma (NPC).

- Histologically or cytologically confirmed non-keratinizing differentiated (World Health Organization WHO Type II) or undifferentiated (WHO Type III) nasopharyngeal carcinoma (NPC) that has recurred at regional or / and distant sites - Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of measurable disease - Received one or more lines of chemotherapy, which must include prior treatment with a platinum agent either for the treatment of metastatic or recurrent disease - Experienced progression of disease within 6 months following completion of a platinum-based combination therapy as part of (neo)-adjuvant therapy - Male or female subjects with age: 18-79 years old - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 - No prior immunotherapy - Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available - Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception - Females of childbearing potential must have negative serum or urine pregnancy test - Have life expectancy ≥ 3 months - Adequate organ function as defined as: Absolute neutrophil count ≥ 1.5 x 10^9/L, Platelet count ≥ 100 x 10^9/L, Hemoglobin >= 8.0 g/dL, Serum alanine aminotransferase ([ALT]; serum glutamate-pyruvate transferase [SGPT]), or serum aspartate aminotransferase [AST] where available at the center) < 2.5 x upper limit of normal (ULN), OR < 5 x ULN in the presence of liver metastases - Serum total bilirubin < 2 x ULN - Serum creatinine < 1.5 x ULN

Study Design

Primary purpose: Treatment , Allocation: N/A , Intervention model: Single Group Assignment , Intervention model description: Single Group Assignment , Masking: None (Open Label)


Nasopharyngeal Carcinoma, Recurrent Carcinoma, Metastatic Cancer, Non-keratinizing Carinoma


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