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

Trial number: NCT04396886
Trial phase: 2 Study type: immunotherapy Overall status: Recruiting

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)

Summary

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

- Prior invasive malignancy within 2 years except for non-invasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of the breast that has been surgically cured - Isolated local recurrence or persistent disease - Has disease that is suitable for local therapy administrated with curative intent - Severe, active co-morbidity - Currently participating in and receiving clinical trial treatment or has participated in a trial of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment - Has prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (≤ grade 1 or at baseline) from adverse events due to previous administered agent - Untreated active central nervous system (CNS) metastatic disease, lepto-meningeal disease, or cord compression - Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (≥New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. - Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms - Irritable bowel syndrome or other serious gastrointestinal chronic conditions associated with diarrhea within the past 3 years prior to the start of treatment - Known history of testing positive for HIV or known acquired immunodeficiency syndrome. - On chronic systemic steroid or any other forms of immunosuppressive medication within 14 days prior to the treatment. Except: Intra-nasal, inhaled, topical steroids, or local steroid injection (e.g., intraarticular injection); Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent; Steroids as premedication for hypersensitivity reactions due to bintrafusp alfa - Active or prior documented autoimmune or inflammatory disorders in the past 2 years, except diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment - Known active hepatitis B or known hepatitis C is detected; subjects who have been treated and now have an undetectable viral load are eligible - History of primary immunodeficiency or solid organ transplantation - Receipt of live, attenuated vaccine within 28 days prior to the study treatment - Active infection requiring systemic therapy - Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb) - Females who are pregnant, lactating, or intend to become pregnant during their participation in the study - Psychiatric disorders and substance (drug/alcohol) abuse

Study Design

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

Conditions

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

Other Study ID Numbers

UW 19-675

Locations

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