Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03707509
Phase
PHASE3
Status
Unknown

Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Maximum 6 cycles for combined therapy. Camrelizumab maintenance.
  • Placebos — DRUG
    Maximum 6 cycles for combined therapy.
  • Gemcitabine — DRUG
    Maximum 6 cycles for combined therapy.
  • Cisplatin — DRUG
    Maximum 6 cycles for combined therapy.

Study Details

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with recurrent/metastatic nasopharyngeal carcinoma who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of camrelizumab in combination with gemcitabine and cisplatin with placebo in combination with gemcitabine and cisplatin in study population in China. camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Key Dates

Start date
Nov 13, 2018
Status verified
Jun 2022
Primary completion
Aug 1, 2021
Completion
Dec 31, 2022

Study Design

Enrollment
263 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab + Gemcitabine + Cisplatin
    subject will receive camrelizumab 200mg every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles
  • Active Comparator: Placebos + Gemcitabine + Cisplatin
    subject will receive placebos every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: up to 24 month ]

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