Recruiting

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)

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).

- 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

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

Locations

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