Bintrafusp Alfa in Previously Treated Patients With R/M Non-keratinizing NPC

NCT04396886 | Completed Phase 2

• 1 other identifier: UW 19-675
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Recurrent; Metastatic; non-keratinizing; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Evaluation of Objective Tumour Response

  To evaluate the objective tumor response (ORR) to bintrafusp alfa in previously treated R/M NPC patients per response evaluation criteria of solid tumor (RECIST) version 1.1

  From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years

Secondary Outcomes (11)

• Progression-Free survival assessment

  From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years

• Time-to-progression (TTP) assessment

  From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years

• Median Survival

  From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years

• Toxicity and Tolerability measurement

  From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years

• Objective Response Rate (ORR)

  From the date of screening to radiographically documented progression according to irRECIST, assessed up to 2 years

Study Arms (1)

Bintrafusp Alfa

EXPERIMENTAL

Single group assignment of bintrafusp alfa in previously treated patients with recurrent and metastatic (R/M) nonkeratinizing nasopharyngeal carcinoma (NPC)

Drug: Bintrafusp Alfa

Interventions

Bintrafusp Alfa DRUG

Bintrafusp alfa will be administered intravenously every 2 weeks

Bintrafusp Alfa

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Recurrence; Neoplasm Metastasis

Interventions

bintrafusp alfa protein, human

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Chi Leung Chiang, FRCR

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: May 21, 2020
• Study Start: February 27, 2020
• Primary Completion: September 30, 2022
• Study Completion: July 26, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

HK (1)