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

Phase 3

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Camrelizumab; Drug: Placebos; Drug: Gemcitabine; Drug: Cisplatin

• Registration Number: NCT03707509
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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 Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-10-14
• Study First Posted: 2018-10-16
• Study Start: 2018-11-13
• Primary Completion: 2021-08-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 263

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Camrelizumab + Gemcitabine + Cisplatin	Camrelizumab	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
Camrelizumab + Gemcitabine + Cisplatin	Gemcitabine	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
Camrelizumab + Gemcitabine + Cisplatin	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
Placebos + Gemcitabine + Cisplatin	Placebos	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
Placebos + Gemcitabine + Cisplatin	Gemcitabine	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
Placebos + Gemcitabine + Cisplatin	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 Measures

Name	Time	Method
Progression-free survival (PFS)	up to 24 month	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	up to 24 month	Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1
Objective Response Rate (ORR)	up to 24 month	The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1
Duration of Response (DoR)	up to 24 month	According to Recist v 1.1 accessed by investigators
Disease Control Rate (DCR) Disease Control Rate (DCR)	up to 24 month	The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1
2 years Overall Survival (OS) rate	up to 24 month	The percentage of patients overall survival in 2 years
Adverse Events (AEs)	up to 24 month	All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03

Trial Locations

Locations (1)

Cancer Center of Sun-Yat Sen University (CCSYSU); 🇨🇳 Guangzhou, Guangdong, China