Overview
SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy.
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2020-12-30
2020-12-30
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
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.