Overview

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