Brief Title
Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma
Official Title
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
Brief 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression-free survival (PFS)
Secondary Outcome
Progression-free survival
Condition
Nasopharyngeal Carcinoma
Intervention
Camrelizumab
Study Arms / Comparison Groups
Camrelizumab + Gemcitabine + Cisplatin
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
250
Start Date
November 13, 2018
Completion Date
November 1, 2021
Primary Completion Date
August 1, 2021
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years and ≤75 years;
2. Subjects with histopathological diagnosis of nasopharyngeal carcinoma;
3. Primarily metastatic (stage IVB as defined by the International Union against Cancer
and American Joint Committee on Cancer staging system for NPC, eighth edition) or
recurrent NPC that is not amenable for local regional treatment or curative treatment;
4. Has not received prior systemic treatment;
5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Status
6. Subject must have a measurable target lesion based on RECIST v1.1;
Exclusion Criteria:
1. Allergic to monoclonal antibodies, any camrelizumab components, gemcitabine, cisplatin
and other platinum drugs;
2. Prior therapy as follow:
- Anti-PD-1 or anti-PD-L1;
- Received last dose of anticancer therapy (including chemotherapy, radiotherapy,
targeted therapy, etc.) within 4 weeks of the first dose of study medication;
- Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone
or equivalent dose) or other systematic immunosuppressive medications within 14
days before the study treatment. Except: inhalation or topical corticosteroids.
Doses > 10 mg/day prednisone or equivalent for replacement therapy;
- Received major operations or serious injuries within 4 weeks of the first dose of
study medication;
3. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a
previously anti-tumor treatment;
4. Pregnancy or breast feeding;
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Li Zhang, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03707509
Organization ID
SHR-1210-III-308
Responsible Party
Sponsor
Study Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor
Li Zhang, MD, Principal Investigator, Cancer Center of Sun-Yat Sen University (CCSYSU)
Verification Date
April 2020