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

Seoul National University Hospital1 site in 1 country53 target enrollmentJune 4, 2020

ConditionsNasopharyngeal Carcinoma

InterventionsPembrolizumab Placebo

DrugsPembrolizumab Placebo

Overview

Phase: Phase 2
Intervention: Pembrolizumab
Conditions: Nasopharyngeal Carcinoma
Sponsor: Seoul National University Hospital
Enrollment: 53
Locations: 1
Primary Endpoint: 3-year progression-free survival (PFS) rate
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

June 4, 2020

End Date

August 21, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Bhumsuk Keam

Clinical Assistant Professor

Seoul National University Hospital

Eligibility Criteria

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
•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)

Exclusion Criteria

•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

Arms & Interventions

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.

Intervention: Pembrolizumab

Placebo

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.

Intervention: Placebo

Outcomes

Primary Outcomes

3-year progression-free survival (PFS) rate

Time Frame: 3 years after the first date of treatment

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

Secondary Outcomes

Overall survival (OS)(3 years after the first date of treatment)
Objective Response rate (RR)(1 year after the first date of treatment)
median Progression-free survival (PFS)(3 years after the first date of treatment)