Consolidation Pembrolizumab After Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

NCT04227509 | Completed Phase 2

• 1 other identifier: CONPELAN
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be treated with pembrolizumab after concurrent chemoradiotherapy with cisplatin. Patients will be treated with up to 17 cycles (approximately 1 year) of pembrolizumab until disease progression or recurrence

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 3-year progression-free survival (PFS) rate

  The percentage of patients who have not experienced disease progression or death from any cause within 3 years from the start of treatment.

  3 years after the first date of treatment

Secondary Outcomes (3)

• Objective Response rate (RR)

  1 year after the first date of treatment

• Overall survival (OS)

  3 years after the first date of treatment

• median Progression-free survival (PFS)

  3 years after the first date of treatment

Study Arms (2)

Experimental

EXPERIMENTAL

Patients will be treated with pembrolizumab after concurrent chemoradiotherapy with cisplatin. Patients will be treated with up to 12 months (17 cycles) of pembrolizumab until disease progression or recurrence.

Drug: Pembrolizumab

Placebo

PLACEBO COMPARATOR

Patients will not be treated with pembrolizumab and will be treated with normal saline after concurrent chemoradiotherapy. Patients will be treated with up to 12 months (17 cycles) of pembrolizumab until disease progression or recurrence.

Drug: Placebo

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.

Experimental

Placebo DRUG

normal saline will be administered as a 30 minute IV infusion every 3 weeks.

Placebo

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically diagnosed nasopharyngeal carcinoma(NPC)
• WHO Type 2a, 2b nonkeratinizing, undifferentiated subtype
• Keratinizing subtype is excluded due to less associated with EBV infection
• Stage II-IVB Locally advanced disease
• a. Stage II-IVB disease must confirmed by initial CT and/or MRI, PET CT at initial diagnosis according to the AJCC 8th edition
• Prior Therapy
• Patients must have received curative radiotherapy (radiation dose ≥ 60Gy) and concurrent cisplatin (cumulative dose ≥ 200mg/m2)
• Induction chemotherapy followed by CCRT is permissible
• CCRT followed by adjuvant FP is permissible
• Patients must have recovered Gr2 or less than Gr2 from all acute, reversible toxic effects from chemotherapy and radiotherapy (excluding alopecia)
• Age 19 or more than 19 years old
• The patient must have an ECOG performance status of 0, 1
• Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
• patient with the willingness to comply with the study protocol during the study period and capable of complying with it
• A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.

You may not qualify if:

• Participants are excluded for patients with a history of other malignancies
• a. except: adequately treated non-melanoma skin cancer, early gastric cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years following the end of treatment and, which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
• History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
• a. Patients with Grave's disease and/or psoriasis not requiring systemic therapy within the last two years from randomization are not excluded.
• History of primary immunodeficiency, history of organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
• Intranasal/inhaled corticosteroids or systemic steroids that do not to exceed 10 mg/day of prednisone or equivalent dose of an alternative corticosteroid are permissible.
• pneumonitis that has required a course of oral steroids to assist with recovery, or a history of interstitial lung disease
• History of diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation
• Live attenuated vaccination administered within 30 days prior to randomization.
• History of severe hypersensitivity (≥Grade 3) to pembrolizumab
• Mean QTc correction \> 470msec in screening ECG measured using standard institutional method or history of familial long QT syndrome.
• Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF \> 50% within 12 weeks prior to randomization.
• Concurrent treatment with other investigational drugs or anti-cancer therapy.
• Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:
• known active tuberculosis (inactive tuberculosis or tuberculosis scar are allowed)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Department of Internal Medicine, Seoul National University Hospital

Seoul, 110-744, South Korea

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

• Bhumsuk Keam, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: June 4, 2020
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)