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Nasopharyngeal CarcinomaPhase 2NCT04227509

Consolidation Pembrolizumab After Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

A Phase 2 study testing Pembrolizumab in people with Nasopharyngeal Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.

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

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 Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
53 participants
Where
1 siteSouth Korea
Study dates
4 Jun 2020to 21 Aug 2024
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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
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  • 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.
  • Have adequate organ function as defined in the following . Specimens must be collected within 10 days prior to the start of study treatment.
  • Hematological Absolute neutrophil count (ANC) ≥1500/µL Platelets ≥100 000/µL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine ≤1.5 × ULN OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)

Who cannot join

  • Participants are excluded for patients with a history of other malignancies
  • 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.
  • 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.
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  • 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)
  • known acute hepatitis B or C by serological evaluation (inactive healthy HBsAg carriers treated with pre-emptive anti-viral agents were allowed)
  • known human immunodeficiency virus infection.
  • Active symptomatic central nervous system (CNS) metastases that the disease also has to have demonstrable stability with no evidence of growth and has not required recent steroid use and/or carcinomatous meningitis
  • Active infection requiring therapy
  • Symptomatic ascites or pleural effusion
  • Pregnant or lactating women. Women of childbearing potential must have a urine pregnancy test proven negative within 14 days prior to randomization. Men and women of child-bearing potential must agree to use adequate contraception as described in protocol
  • Prior organ transplant or allogeniec bone marrow transplant regardless of whether immunosuppressive therapy has been used in the past

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Department of Internal Medicine, Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: A Randomized Phase II Study of CONsolidation PEmbrolizumab After Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

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

Read the detailed description

Phase II multi-center, randomized controlled trial of consolidation pembrolizumab after chemoradiotherapy in locally advanced nasopharyngeal carcinoma

Being tested
Pembrolizumab, Placebo
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • PembrolizumabDrug

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

  • PlaceboDrug

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

Study groups in NCT04227509
Study groupRoleWhat they receive
ExperimentalExperimentalPatients 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.
Receives: Drug: Pembrolizumab
PlaceboPlacebo comparatorPatients 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.
Receives: Drug: Placebo

What is being measured

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

  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.

    Measured: 3 years after the first date of treatment

Secondary outcomes (3)

  1. Objective Response rate (RR)

    The percentage of patients who are either CR or PR within 3 years from the start of treatment.

    Measured: 1 year after the first date of treatment

  2. Overall survival (OS)

    The duration from the first date of treatment to the date of death from any cause or follow-up

    Measured: 3 years after the first date of treatment

  3. median Progression-free survival (PFS)

    The time at which half of the patients in a study have experienced disease progression or death, and half have not.

    Measured: 3 years after the first date of treatment

Timeline

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

  1. First posted13 Jan 2020
  2. Study start4 Jun 2020
  3. Primary completion21 Aug 2024
  4. Study completion21 Aug 2024

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04227509
Sponsor's protocol ID
CONPELAN
Status last verified
Dec 2025
First submitted
8 Jan 2020
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Nasopharyngeal Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.

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 17 inclusion and 22 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 31 Dec 2025. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?

3-year progression-free survival (PFS) rate (time frame: 3 years after the first date of treatment). 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 NCT04227509.

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 31 Dec 2025.

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