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SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363555
Recruitment Status : Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 29, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE May 29, 2018
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
objective response rate [ Time Frame: from first patient first visit to 6 month after last patient first visit ]
rate of subjects achieved complete response plus partial response in all evaluable subjects
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
Official Title  ICMJE An Open-Label, Single Arm, Multi-Center, Phase 2 Study of PD-1 Antibody SHR-1210 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
Brief Summary This is an open-label, multi-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 in subjects with relapsed or refractory extranodal NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
Detailed Description The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory extranodal NK/T cell lymphoma. The secondary objective is to observe time to response,progression free survival rate at 2 years,overall survival rate at 2 years,safety and immunogenicity of SHR-1210 in relapsed or refractory extranodal NK/T cell lymphoma.The relationship of PD-L1 expression in tumor tissue and EBV-DNA copies in blood to SHR-1210 efficacy in these patients would also be explored.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Extranodal NK/T-cell Lymphoma, Nasal Type
Intervention  ICMJE Drug: SHR-1210
A humanized monoclonal immunoglobulin.
Study Arms  ICMJE Experimental: SHR-1210
SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes.
Intervention: Drug: SHR-1210
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2017)
97
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed extranodal NK/T cell lymphoma;
  2. Relapsed or refrsctory cHL and received L-asparaginase based chemotherapy.
  3. Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
  4. Need to provide ≥5 tumor tissue sections for detection.
  5. ECOG performance status of 0 or 1;
  6. Life expectancy ≥ 12 weeks.;
  7. Adequate laboratory parameters during the screening period as evidenced by the following:

    1. Absolute neutrophil count ≥ 1.0× 109/L ;
    2. Platelets ≥ 75 × 109/L;
    3. Hemoglobin ≥ 8.0 g/dL;
    4. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN
    5. Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min;
    6. Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN
  8. Women of childbearing potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation; Male subjects with WOCBP partner should receive Surgical sterilization orconsent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.
  9. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

  1. invasive NK cell leukemia or precursor NK cell tumor
  2. Known central nervous system lymphoma
  3. Haemophilus cell syndrome at diagnosis
  4. Large lung vessels were involved
  5. History and complication

    1. Recieved anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months.
    2. Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
    3. Participating in other clinical studies or less than 4 weeks before the end of a clinical trial;
    4. Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted.
    5. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10mg.
    6. Known and suspicion of interstitial pneumonia
    7. Other active malignancies that required treating.
    8. Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except trichomadesis) did not recover to CTCAE ≤1.
    9. Prior allo-HSCT.
    10. ASCT within 90 days.
    11. Impact of major surgery or severe trauma had been eliminated for less than 14 days.
    12. Active pulmonary tuberculosis.
    13. Severe acute or chronic infection requiring systemic therapy.
    14. Suffering from heart failure (New York Heart Association standard III or IV) and given appropriate medical treatment.Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months.
  6. laboratory test

    1. known HIV positive or known AIDS.
    2. Untreated active hepatitis; Hepatitis B and hepatitis C infection in common.
  7. Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03363555
Other Study ID Numbers  ICMJE SHR-1210-II-205
Has Data Monitoring Committee Not Provided
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 Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date June 2020

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