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A Study to Evaluate the Safety and Efficacy of Using the Combination Treatment of SHR-1210, Gemcitabine and Cis-platinum by Recurrent and Metastatic NPC Subjects

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Jiangsu HengRui Medicine Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03121716
First received: April 13, 2017
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
This is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210, gemcitabine and cis-platinum by recurrent and metastatic NPC.

Condition Intervention Phase
Nasopharyngeal Carcinoma
Biological: SHR-1210
Drug: Gemcitabine
Drug: cis-platinum
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-Label, Single Center, Nonrandomized, Phase 1 Study to Evaluate Safety and Efficacy of Using the Combination Treatment of SHR-1210, Gemcitabine and Cis-platinum by Recurrent and Metastatic NPC

Resource links provided by NLM:


Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • progression of disease [ Time Frame: 28 days ]
    progression of disease by radiographic examination


Estimated Enrollment: 20
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SHR-1210, gemcitabine and cis-platinum
Subjects receive SHR-1210 200mg (Day 1) and gemcitabine 1000mg/m2 (Day 1 and Day 8)and cis-platinum 80mg/m2 (Day 1) of each 21-day cycle for at most 6 cycles, followed by SHR-1210 200mg every three weeks (Q3W) maintenance for the remainder of the study or until documented PD.
Biological: SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Drug: Gemcitabine
gemcitabine
Other Name: Gemcitabine Hydrochloride for Injection
Drug: cis-platinum
cis-platinum
Other Name: Cisplantin Injection

Detailed Description:

This is an open-label, single center, nonrandomized, Phase 1 study to evaluate safety and efficacy of using the combination treatment of SHR-1210, gemcitabine and cis-platinum by recurrent and metastatic NPC.

The safety of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be conducted (immune-related adverse events (AEs), or labs of autoimmune sera, inflammatory events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.Tumor response will be assessed by radiographic examination in screening visit and every 2 cycles after first dose.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 18-70 years of age.
  2. Subjects diagnosed with pathological confirmed Primary metastatic nasopharyngeal carcinoma, or subjects with recurrent NPC that is unfit for local treatment.
  3. Subjects with recurrent and metastatic NPC who did't receive any Systemic chemotherapy, neoadjuvant chemotherapy, concurrent radiochemotherapy and adjuvant chemotherapy 6 month before first dose are excepted.
  4. ECOG performance status of 0 or 1.
  5. Life expectancy more than 12 weeks.
  6. Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
  7. Adequate laboratory parameters during the screening period as evidenced by the following:

    • Absolute neutrophil count ≥1.5*10E9/L;
    • Platelets ≥100*10E9/L;
    • Hemoglobin ≥9.0 g/dL;
    • Albumin (ALB) levels ≥2.8 g/dL;
    • Total bilirubin (TBIL)≥1.5 upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5 upper limit of normal(ULN); for subjects with liver metastases, ALT and AST ≥5 ULN;
    • creatinine clearance rate ≥50mL/min;
  8. Female subjects agree not to be pregnant or lactating from beginning of the study screening through at least 3 months after receiving the last dose of study treatment. Both men and women of reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy. A highly effective method of contraception is defined as one that results in a low failure rate, that is, less than 1% per year when used consistently and correctly
  9. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

  1. Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval;
  2. Known history of hypersensitivity to any components of the SHR-1210 formulation;
  3. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed;
  4. Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease);
  5. Uncontrolled clinically significant medical condition, including but not limited to the following:

    • congestive heart failure (New York Health Authority Class > 2),
    • unstable angina,
    • myocardial infarction within the past 12 months, or
    • clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
  6. Active infection or an unexplained fever; 38.5℃ during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled);
  7. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease;
  8. Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results;
  9. Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation based on institutional guidelines and tests. Testing may include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03121716     History of Changes
Other Study ID Numbers: SHR-1210-104
Study First Received: April 13, 2017
Last Updated: April 17, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine
Cisplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017