shr-1210 in recurrent/metastatic nasopharyngeal carcinoma who have received previous at least two lines of chemotherapy.

Conditions: Nasopharyngeal Carcinoma

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.

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.

Eligibility 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.

Keywords: recurrent/metastatic nasopharyngeal carcinoma pd-1