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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03707509
• Other study ID #: SHR-1210-III-308
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 13, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 263
• Est. completion date: December 31, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Camrelizumab
Maximum 6 cycles for combined therapy. Camrelizumab maintenance.
• Placebos
Maximum 6 cycles for combined therapy.
• Gemcitabine
Maximum 6 cycles for combined therapy.
• Cisplatin
Maximum 6 cycles for combined therapy.

Locations

Country	Name	City	State
China	Cancer Center of Sun-Yat Sen University (CCSYSU)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antidrug Antibodies (ADAs)	To evaluate the incidence and titers of ADAs against camrelizumab	up to 24 month
Primary	Progression-free survival (PFS)	PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first.	up to 24 month
Secondary	Progression-free survival	Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1	up to 24 month
Secondary	Objective Response Rate (ORR)	The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1	up to 24 month
Secondary	Disease Control Rate (DCR) Disease Control Rate (DCR)	The proportion of patients who have achieved complete response, partial response and Stable disease assessed by investigators according to Recist v 1.1	up to 24 month
Secondary	Duration of Response (DoR)	According to Recist v 1.1 accessed by investigators	up to 24 month
Secondary	2 years Overall Survival (OS) rate	The percentage of patients overall survival in 2 years	up to 24 month
Secondary	Adverse Events (AEs)	All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03	up to 24 month