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

• Status: Not yet recruiting
• Trial end date: 2023-01-30
• Target enrollment: 37
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborator: Merck KGaA, Darmstadt, Germany

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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