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

STATUS

Recruiting
participants needed

37
sponsor

The University of Hong Kong

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Updated on 19 February 2024

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platelet count

measurable disease

metastasis

neutrophil count

liver metastasis

serum aspartate aminotransferase

nasopharyngeal carcinoma

carcinoma

immunomodulators

combination therapy

adjuvant therapy

recurrent disease

secondary malignant neoplasm of liver

serum bilirubin level

serum total bilirubin level

serum total bilirubin

bintrafusp alfa

infectious mononucleosis

adjuvant

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).

Description

All the patients must be registered with the Investigator(s) prior to initiation of treatment. The registration desk will confirm all eligibility criteria and obtain essential information (including patient number). Patients shall receive Bintrafusp alfa treatment through intravenous therapy every two weeks up until disease progression, unacceptable toxicity or for a maximum of 2 years. Survival Follow-up till 2 years will also be performed.

Details

Condition	Metastasis, Brain Metastases, Liver Metastases, neoplasm metastasis, Carcinoma, vulvar dysplasia and carcinoma, Nasopharyngeal Cancer, Nasopharyngeal Cancer, Brain Metastases, Liver Metastases, neoplasm metastasis, vulvar dysplasia and carcinoma, Recurrent Carcinoma, Non-keratinizing Carinoma
Age	18years - 79years
Treatment	Bintrafusp Alfa
Clinical Study Identifier	NCT04396886
Sponsor	The University of Hong Kong
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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