Consolidation Pembrolizumab After Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma (NCT04227509) | Clinical Trial Compass
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 range20 Years
SexALL
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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 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.
What they're measuring
1
3-year progression-free survival (PFS) rate
Timeframe: 3 years after the first date of treatment
✕. 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