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SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy.

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ClinicalTrials.gov Identifier: NCT03558191
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
This is an open label, single-arm, multi-center, phase 2 Study of SHR-1210 in recurrent/metastatic nasopharyngeal carcinoma(R/M NPC) patients who have received previous at least two lines of chemotherapy.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: SHR-1210 Phase 2

Detailed Description:
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with R/M NPC. The secondary objective is to observe the duration of response, progression free survival, time to response, overall survival and safety of SHR-1210 in R/M NPC. ADA is also investigated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open Label, Multi-center, Phase 2 Study of SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Patients Who Have Received Previous At Least Two Lines of Chemotherapy.
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Injection SHR-1210
SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes.
Drug: SHR-1210
A humanized monoclonal immunoglobulin PD-1 antibody
Other Name: Camrelizumab




Primary Outcome Measures :
  1. Objective Response Rate (ORR) assess by Independent Review Committee (IRC) [ Time Frame: from first patient first visit to 6 month after last patient first visit ]
    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)


Secondary Outcome Measures :
  1. ORR assess by investigators [ Time Frame: from first patient first visit to 6 month after last patient first visit ]
    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

  2. Duration of Response (DoR) [ Time Frame: up to approximately 1 year ]
    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

  3. Disease Control Rate (DCR) [ Time Frame: from first patient first visit to 6 month after last patient first visit ]
    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

  4. Progression-Free Survival (PFS) [ Time Frame: up to approximately 1 year ]
    PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

  5. Overall Survival (OS) [ Time Frame: up to approximately 1 year ]
    Overall Survival is defined as the time from registration to death due to any cause, or censored at date last known alive. OS will be measured by the Method of Kaplan and Meier.



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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. Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma (WHO type II-III);
  2. Stage IVb R/M NPC failed from first-line platinum based chemotherapy and second-line chemotherapy;
  3. ECOG performance status of 0 or 1;
  4. Life expectancy ≥ 12 weeks;
  5. Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;
  6. Can provide either a newly obtained or archival tumor tissue sample;
  7. Adequate laboratory parameters during the screening period as evidenced by the following:

    1. Absolute neutrophil count ≥ 1.5 × 10^9/L ;
    2. Platelets ≥ 90 × 10^9/L;
    3. Hemoglobin ≥ 9.0 g/dL;
    4. Serum albumin ≥ 2.8g/dL;
    5. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 1.5×ULN
    6. Creatinine clearance≥50 mL/min;
  8. Female of child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 60 days after the last dose of SHR-1210. Male subjects with WOCBP partner must be willing to use adequate contraception for the course of the study through 120 days after the last dose of SHR-1210;
  9. Subjects must be willing to participate in the research and sign an informed consent form (ICF);

Exclusion Criteria:

  1. Subjects with any active autoimmune disease or history of autoimmune disease;
  2. Subjects having clinical symptoms of metastases to central nervous system (such as cerebral edema, requiring steroids intervention, or brain metastasis progression);
  3. Has a known additional malignancy within the last 5 years before study treatment with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers;
  4. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
  5. 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;
  6. Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy within 4 weeks prior to first dosing or not recovered to ≤CTCAE 1 from adverse events (except for hair loss or neurotoxic sequelae from prior platinum therapy) due to a previously administered agent. Palliative irradiation should be ended 2 weeks before first dosing;
  7. Active infection or an unexplained fever > 38.5°C before two weeks of first dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
  8. Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C;
  9. Currently participating or has participated in a study within 4 weeks of the first dose of study medication;
  10. Received a live vaccine within 4 weeks of the first dose of study medication. Pregnancy or breast feeding;
  11. Received a systematic antibiotics within 4 weeks of the first dose of study medication.

    Pregnancy or breast feeding.

  12. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;
  13. Subjects are known to have a history of psychiatric substance abuse, alcoholism, or drug addiction;
  14. Pregnancy or breast feeding;
  15. According to the investigator, other conditions that may lead to stop the research.

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): NCT03558191


Contacts
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Contact: Qing Yang, MD +86-021-68868570 ext 836 yangqing@hrs.com.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: NCT03558191     History of Changes
Other Study ID Numbers: SHR-1210-II-209
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: June 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.:
Recurrent/Metastatic Nasopharyngeal Carcinoma
PD-1

Additional relevant MeSH terms:
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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
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases