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

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ClinicalTrials.gov Identifier: NCT03707509
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE October 16, 2018
Last Update Posted Date December 19, 2018
Actual Study Start Date  ICMJE November 13, 2018
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2018)
Progression-free survival (PFS) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03707509 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2018)
  • Progression-free survival [ Time Frame: up to 24 month ]
    Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1
  • Objective Response Rate (ORR) [ Time Frame: up to 24 month ]
    The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1
  • Disease Control Rate (DCR) Disease Control Rate (DCR) [ Time Frame: 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
  • Duration of Response (DoR) [ Time Frame: up to 24 month ]
    According to Recist v 1.1 accessed by investigators
  • 2 years Overall Survival (OS) rate [ Time Frame: up to 24 month ]
    The percentage of patients overall survival in 2 years
  • Adverse Events (AEs) [ Time Frame: up to 24 month ]
    All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 14, 2018)
Antidrug Antibodies (ADAs) [ Time Frame: up to 24 month ]
To evaluate the incidence and titers of ADAs against camrelizumab
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: Camrelizumab
    Maximum 6 cycles for combined therapy. Camrelizumab maintenance.
    Other Name: SHR-1210
  • Drug: Placebos
    Maximum 6 cycles for combined therapy.
    Other Name: Placebo - Concentrate
  • Drug: Gemcitabine
    Maximum 6 cycles for combined therapy.
    Other Name: Gemcitabine Hydrochloride for Injection
  • Drug: Cisplatin
    Maximum 6 cycles for combined therapy.
    Other Name: Cisplantin Injection
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Camrelizumab
    • Drug: Gemcitabine
    • Drug: Cisplatin
  • 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
    Interventions:
    • Drug: Placebos
    • Drug: Gemcitabine
    • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2018)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qing Yang, MD +86-021-68868570 ext 836 yangqing@hrglobe.cn
Contact: Di Zong, Master +86-010-53806899 zongdi@hrglobe.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03707509
Other Study ID Numbers  ICMJE SHR-1210-III-308
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li Zhang, MD Cancer Center of Sun-Yat Sen University (CCSYSU)
Study Director: Qing Yang, MD Jiangsu HengRui Medicine Co., Ltd.
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP