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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.

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Camrelizumab Drug: Placebos Drug: Gemcitabine Drug: Cisplatin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : November 1, 2021


Arm Intervention/treatment
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
Drug: Camrelizumab
Maximum 6 cycles for combined therapy. Camrelizumab maintenance.
Other Name: SHR-1210

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

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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to 24 month ]
    Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1

  2. 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

  3. 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

  4. Duration of Response (DoR) [ Time Frame: up to 24 month ]
    According to Recist v 1.1 accessed by investigators

  5. 2 years Overall Survival (OS) rate [ Time Frame: up to 24 month ]
    The percentage of patients overall survival in 2 years

  6. 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


Other Outcome Measures:
  1. Antidrug Antibodies (ADAs) [ Time Frame: up to 24 month ]
    To evaluate the incidence and titers of ADAs against camrelizumab



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707509


Contacts
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Contact: Qing Yang, MD +86-021-68868570 ext 836 yangqing@hrglobe.cn
Contact: Di Zong, Master +86-010-53806899 zongdi@hrglobe.cn

Locations
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China, Guangdong
Cancer Center of Sun-Yat Sen University (CCSYSU) Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Zhang, MD    +86-020-87343458    zhangli6@mail.sysu.edu.cn   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Li Zhang, MD Cancer Center of Sun-Yat Sen University (CCSYSU)
Study Director: Qing Yang, MD Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03707509     History of Changes
Other Study ID Numbers: SHR-1210-III-308
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Nasopharyngeal Carcinoma
PD-1 Antibody
Cisplatin
Gemcitabine
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs