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Nasopharyngeal CarcinomaPhase 2NCT04396886

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

A Phase 2 study testing Bintrafusp Alfa in people with Nasopharyngeal Carcinoma and Recurrent Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
Bintrafusp Alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteHong Kong
Study dates
27 Feb 2020to 26 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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).

Read the detailed 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.

Being tested
Bintrafusp Alfa
Keywords
Recurrent, Metastatic, non-keratinizing, Nasopharyngeal Carcinoma
Medical subject headings
Nasopharyngeal Carcinoma, Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bintrafusp AlfaDrug

    Bintrafusp alfa will be administered intravenously every 2 weeks

Study groups in NCT04396886
Study groupRoleWhat they receive
Bintrafusp AlfaExperimentalSingle group assignment of bintrafusp alfa in previously treated patients with recurrent and metastatic (R/M) nonkeratinizing nasopharyngeal carcinoma (NPC)
Receives: Drug: Bintrafusp Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (11)

  1. Progression-Free survival assessment

    To assess the progression-free survival (PFS) per RECIST version 1.1

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

  2. Time-to-progression (TTP) assessment

    To assess the time-to-progression (TTP) per RECIST version 1.1

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

  3. Median Survival

    To assess the median survival

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

  4. Toxicity and Tolerability measurement

    To measure the toxicities and tolerability in previously treated R/M NPC patients receiving bintrafusp alfa with the most updated version of CTCAE criteria

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

  5. Objective Response Rate (ORR)

    To evaluate ORR, PFS and TTP per immune-related RECIST (irRECIST)

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

  6. Survival rate assessment

    To measure the survival rate in 12 months and 24 months

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

  7. Duration of Response (DOR) evaluation

    To evaluate the duration of response (DOR) in previously treated R/M NPC patients receiving bintrafusp alfa

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

  8. Investigate the relationship between the response to bintrafusp alfa and plasma Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) level

    EBV-DNA will be determined using real-time quantitative polymerase chain reaction and the clearance (half-life) during the first 4 weeks of bintrafusp alfa will be measured. The half-life will be correlated with patients ORR, PFS, and OS

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

  9. Disease Control Rate (DCR)

    Defined as the percentage of patients with a CR, PR, or SD ≥ 6 months per RECIST 1.1

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

  10. Time to Response (TTR)

    Defined as the duration to first documented tumor response

    Measured: From the date of screening to first radiographically documented tumor response according to RECIST 1.1, assessed up to 2 years

  11. Quality of Life (QoL)

    To evaluate via the patient-reported EORTC-QLQ-C30 and H\&N-35 questionnaires

    Measured: Every 12 weeks from the date of screening in the first year of study enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start27 Feb 2020
  3. Primary completion30 Sep 2022
  4. Study completion26 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04396886
Sponsor's protocol ID
UW 19-675
Status last verified
May 2024
First submitted
14 Apr 2020
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bintrafusp Alfa in people with Nasopharyngeal Carcinoma and Recurrent Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Objective Tumour Response (time frame: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04396886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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