NCT03707509

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

A Phase III, Randomized, Double-Blind, Multi-center Study to Investigate the Efficacy and Safety of Camrelizumab+Gemcitabine+Cisplatin Versus Placebo+Gemcitabine+Cisplatin in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Treatment cycles of chemotherapy will be at most 6 weeks which will be decided by investigators. Progression-free survival (PFS) determined by the Independent Review Committee (IRC) will be the primary outcome measures.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	Maximum 6 cycles for combined therapy. Camrelizumab maintenance.
DRUG	Placebos	Maximum 6 cycles for combined therapy.
DRUG	Gemcitabine	Maximum 6 cycles for combined therapy.
DRUG	Cisplatin	Maximum 6 cycles for combined therapy.

Timeline

• Start date: 2018-11-13
• Primary completion: 2021-08-01
• Completion: 2022-12-31
• First posted: 2018-10-16
• Last updated: 2022-07-01

Locations

1 site across 1 country: China