Pembrolizumab for Nasopharyngeal Carcinoma Patients With Detectable Plasma Epstein-Barr Virus DNA

NCT03544099 | Terminated Phase 2 DMC

• 1 other identifier: T1317
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 8

Brief Summary

This is a single-arm, multi-center, open-label, phase II trial to examine the efficacy of pembrolizumab for prolonging the one-year disease free survival in nasopharyngeal carcinoma patients with solely detectable EBV DNA after curative chemoradiation. Sixty-three patients will be enrolled in the trial.

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• prolong one-year disease free survival (DFS-1y)

  To examine the efficacy of pembrolizumab to prolong one-year disease free survival (DFS-1y) in nasopharyngeal carcinoma (NPC) patients with detectable plasma Epstein-Barr virus (EBV) DNA after curative chemoradiation.

  5 years

Study Arms (1)

Pembrolizumab for NPC patients

EXPERIMENTAL

Pembrolizumab 200 mg Q3W IV infusion, Day 1 of each 3 week cycle, for 35 cycles

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

Pembrolizumab 200mg Intravenous Solution

Also known as: KEYTRUDA

Pembrolizumab for NPC patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent/assent for the trial.
• Be more than 20 years of age on day of signing informed consent.
• Have a performance status of 0 or 1 on the ECOG Performance Scale
• Demonstrate adequate organ function as defined in Table 2
• Hematological
• Absolute neutrophil count (ANC) ≥1,500 /mcL
• Platelets ≥100,000 / mcL
• Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
• Renal Serum creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN
• Hepatic
• Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
• AST (SGOT) and ALT (SGPT)≤ 2.5 X ULN
• Albumin \>2.5 mg/dL
• Coagulation
• International Normalized Ratio (INR) or Prothrombin Time (PT)

You may not qualify if:

• The subject must be excluded from participating in the trial if the subject:
• Other malignancies diagnosed before or concurrently with the diagnosis of NPC.
• Take chemotherapy or other anti-cancer agents after curative chemoradiation.
• Documented residual / recurrent local disease or distant metastases after completing chemoradiation.
• Plasma EBV DNA is un-detectable.
• Unresolved grade 2 or more acute toxicities related to chemoradiation
• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• Hypersensitivity to pembrolizumab or any of its excipients.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Topical or inhaled steroids is not considered as systemic treatment.
• Has known history of pneumonitis requiring steroids, or any evidence of active, non-infectious pneumonitis
• Has an active infection requiring systemic therapy 14 days before signing informed consent.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• Koo Foundation Sun Yat-Sen Cancer Center: collaborator
• Chang Gung Memorial Hospital: collaborator
• Taichung Veterans General Hospital: collaborator
• China Medical University Hospital: collaborator
• Changhua Christian Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator

Study Sites (8)

Changhua Christian Hospital

Changhua, Taiwan

Location

Chang Gung Memorial Hospital

Linkou District, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

pembrolizumab

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

Study Officials

• Ruey-Long Hong, PhD

  National Taiwan University Hospital

  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: SPONSOR

Model Details: Interventional

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: May 7, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (8)