Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

NCT04910347 | Recruiting Phase 2

• 1 other identifier: 4-2021-0330
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical efficacy of nivolumab for locally advanced nasopharyngeal carcinoma patients with residual disease after standard chemoradiotherapy is not known. In this study, we aim to investigate the role of nivolumab in locally advanced NPC after chemoradiotherapy the safety profile and antitumor activity of the anti-programmed death 1 (PD-1) receptor monoclonal antibody, nivolumab after in patients with advanced nasopharyngeal carcinoma

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) rate at 2years

  Progression-free survival rate at 2 years, which is the primary endpoint, will be measured by the proportion of patients who remain progression-free after 2 years of study registration.

  2 years

Secondary Outcomes (6)

• Object response rate (ORR)

  Screening, Every 3months during the administration period(up to 1year), every 6 months after the end of the administration(up to 5years)

• Overall survival (OS)

  Intervals of 6 months up to 5 years after the end of dosing

• Subject with Treatment Related Adverse Events as Assessed by CTCAE v5.0

  Every cycle (every 3weeks), until 28 days after the end of treatment.

• Multiplexed biomarker analysis of tumor and immune cells in the TME

  At screening, At cycle2 day1(each cycle is 28 days), End of treatment (up to a total of 1 year)

• Analysis of gene expression profile and immune markers

  At screening, At cycle2 day1(each cycle is 28 days), End of treatment (up to a total of 1 year)

Study Arms (1)

Single Arm

EXPERIMENTAL

Nivolumab

Drug: Nivolumab

Interventions

Nivolumab DRUG

Dosage within 12 weeks after the end of concurrent chemoradiation therapy. Nivolumab 360mg Intravenously administered every 3 weeks. As a consolidation regimen, administration of Nivolumab is administered for up to a total of 1 year until disease progression or unacceptable to toxicity occurs.

Single Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age (at the time of informed consent): 19 years and older
• Subjects with histologically- or cytologically-confirmed advanced Nasopharyngeal cancer (Stage II -IVa) according to 8th edition clinical staging system of the American Joint Committee on Cancer before the start of concurrent chemoradiotherapy
• Patients who have recovered from previous toxicities of standard chemoradiotherapy (Grade ≤1).
• ECOG (Eastern Cooperative Oncology Group) Performance Status Score 0 or 1
• Patients with a life expectancy of at least 3 months
• Patients whose latest laboratory data meet the below criteria within 7 days before registration. If the date of the laboratory tests at the time of registration is not within 7 days before the first dose of the investigational product, testing must be repeated within 7 days before the first dose of the investigational product, and these latest laboratory tests must meet the following criteria. Of note, laboratory data will not be valid if the patient has received a granulocyte colony-stimulating factor (G-CSF) or blood transfusion within 14 days before testing.
• White blood cells ≥2,000/mm3 and neutrophils ≥1,500/mm3
• Platelets ≥100,000/mm3
• Hemoglobin ≥9.0 g/dL
• AST (GOT) and ALT (GPT) ≤3.0-fold the upper limit of normal (ULN) of the study site (or ≤5.0-fold the ULN of the study site in patients with liver metastases)
• Total bilirubin ≤1.5-fold the ULN of the study site
• Creatinine ≤1.5-fold the ULN of the study site or creatinine clearance (either the measured or estimated value using the Cockcroft-Gault equation) \>45 mL/min
• Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) #1 must agree to use contraception#2 from the time of informed consent until 5 months or more after the last dose of the investigational product. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the investigational product.
• Men must agree to use contraception#2 from the start of study treatment until 7 months or more after the last dose of the investigational product.

You may not qualify if:

• Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 5 years)
• Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or sub-investigator.
• Patients with current or past history of severe hypersensitivity to any other antibody products
• Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
• Patients with a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings. Patients with radiation pneumonitis may be randomized if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence.
• Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
• Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment. Patients may be randomized if the metastasis is asymptomatic and requires no treatment.
• Patients with pericardial fluid, pleural effusion, or ascites requiring treatment
• Patients with uncontrollable, tumor-related pain
• Patients who have experienced a transient ischemic attack, cerebrovascular accident, thrombosis, or thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days before registration
• Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:
• Myocardial infarction within 180 days before registration
• Uncontrollable angina pectoris within 180 days before registration
• New York Heart Association (NYHA) Class III or IV congestive heart failure
• Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥ 90 mmHg lasting 24 hours or more)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hye Ryun Kim

  Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hye Ryun Kim

CONTACT

+82-2228-0880; nobelg@yuhs.ac

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: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 2, 2021
• Study Start: February 7, 2022
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)