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

NCT03558191 | Completed Phase 2 Results

• 1 other identifier: SHR-1210-II-209
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Recurrent/Metastatic Nasopharyngeal Carcinoma; PD-1

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Assess by Independent Review Committee (IRC)

  Percentage of participants achieved partial response (PR) or complete response (CR) based on IRC assessment according to the RECIST (version 1.1) is presented for this endpoint. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response .

  Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death ，whichever was earlier, approximately 3 years.

Secondary Outcomes (5)

• ORR Assess by Investigators

  Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.

• Duration of Response (DoR)

  Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.

• Disease Control Rate (DCR)

  Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.

• Progression-Free Survival (PFS)

  Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.

• Overall Survival (OS)

  Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.

Study Arms (1)

SHR-1210 Injection

EXPERIMENTAL

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

Drug: SHR-1210

Interventions

SHR-1210 DRUG

A humanized monoclonal immunoglobulin PD-1 antibody

Also known as: Camrelizumab

SHR-1210 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma (WHO type II-III);
• Stage IVb R/M NPC failed from first-line platinum based chemotherapy and second-line chemotherapy;
• ECOG performance status of 0 or 1;
• Life expectancy ≥ 12 weeks;
• Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;
• Can provide either a newly obtained or archival tumor tissue sample;
• Adequate laboratory parameters during the screening period as evidenced by the following:
• Absolute neutrophil count ≥ 1.5 × 10\^9/L ;
• Platelets ≥ 90 × 10\^9/L;
• Hemoglobin ≥ 9.0 g/dL;
• Serum albumin ≥ 2.8g/dL;
• Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 1.5×ULN
• Creatinine clearance≥50 mL/min;
• 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;
• Subjects must be willing to participate in the research and sign an informed consent form (ICF);

You may not qualify if:

• Subjects with any active autoimmune disease or history of autoimmune disease;
• Subjects having clinical symptoms of metastases to central nervous system (such as cerebral edema, requiring steroids intervention, or brain metastasis progression);
• 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;
• 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;
• 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;
• 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;
• 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);
• Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C;
• Currently participating or has participated in a study within 4 weeks of the first dose of study medication;
• Received a live vaccine within 4 weeks of the first dose of study medication. Pregnancy or breast feeding;
• Received a systematic antibiotics within 4 weeks of the first dose of study medication.
• Pregnancy or breast feeding.
• Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;
• Subjects are known to have a history of psychiatric substance abuse, alcoholism, or drug addiction;
• Pregnancy or breast feeding;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Cancer Center of Sun-Yat Sen University (CCSYSU)

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 37409613 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Project manager
• Organization: Jiangsu HengRui Pharmaceuticals Co., Ltd.

linan.wang@hengrui.com

0518-82342973

Study Officials

• Li Zhang, MD

  Cancer Center of Sun-Yat Sen University (CCSYSU)

  PRINCIPAL INVESTIGATOR

• Qing Yang, MD

  Jiangsu HengRui Medicine Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 15, 2018
• Study Start: August 14, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 15, 2024
• Results First Posted: March 15, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)