CompletedPhase 2

Consolidation Pembrolizumab After Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

South Korea53 participantsStarted 2020-06-04

Plain-language 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

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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

Exclusion criteria

. Participants are excluded for patients with a history of other malignancies
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

3-year progression-free survival (PFS) rate

Timeframe: 3 years after the first date of treatment

Trial details

NCT IDNCT04227509

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-21

View on ClinicalTrials.gov More Nasopharyngeal Carcinoma trials