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

NCT ID: NCT03558191

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-14
• Study Completion Date: 2021-12-30

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.

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1210 Injection

SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks .

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

A humanized monoclonal immunoglobulin PD-1 antibody

Interventions

SHR-1210

A humanized monoclonal immunoglobulin PD-1 antibody

Intervention Type: DRUG

Other Intervention Names

Camrelizumab

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Center of Sun-Yat Sen University (CCSYSU)

Qing Yang, MD

Role: STUDY_DIRECTOR

Jiangsu HengRui Medicine Co., Ltd.

Locations

Cancer Center of Sun-Yat Sen University (CCSYSU)

Guangzhou, Guangdong, China

Countries

China

References

Xiao BJ, Sima XX, Chen G, Gulizeba H, Zhou T, Huang Y. Predictive and prognostic role of early apolipoprotein A-I alteration in recurrent or metastatic nasopharyngeal carcinoma patients treated with anti-PD-1 therapy. Cancer Med. 2023 Aug;12(16):16918-16928. doi: 10.1002/cam4.6321. Epub 2023 Jul 6.

Reference Type: DERIVED

PMID: 37409613 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SHR-1210-II-209

Identifier Type: -

Identifier Source: org_study_id