PD-1 Antibody Versus Best Supportive Care After Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

NCT03427827 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: B2017-097-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 11

Brief Summary

This trial is aimed to investigate whether adjuvant PD-1 antibody treatment could improve survival in locoregionally advanced nasopharyngeal carcinoma compared to best supportive care.

Conditions

Nasopharyngeal Neoplasms

Keywords

PD-1 antibody; Adjuvant treatment; Immune checkpoint inhibitors

Outcome Measures

Primary Outcomes (1)

• failure-free survival

  calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.

  3 years

Secondary Outcomes (5)

• overall survival

  5 years

• distant metastasis-free survival

  3 years

• locoregional recurrence-free survival

  3 years

• adverse events (AEs) and severe adverse events (SAE)

  3 years

• quality of life (QoL)

  3 years

Study Arms (2)

Adjuvant PD-1 antibody arm

EXPERIMENTAL

Patients randomized to this arm will receive PD-1 antibody (SHR-1210), 200mg, ivdrip (\>30 minutes), d1, q3w × 12 cycles, begining at 4-6 weeks after chemoradiation

Drug: Camrelizumab

Best supportive care

NO INTERVENTION

Patients randomized to this arm will receive best supportive care after chemoradiation

Interventions

Camrelizumab DRUG

Camrelizumab is an antibody targeting PD-1 developed by Jiangsu Hengrui Medicine, China.

Also known as: SHR-1210

Adjuvant PD-1 antibody arm

Eligibility Criteria

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

You may qualify if:

• Patients with histologically confirmed nasopharyngeal carcinoma.
• Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0).
• Completed protocol-specified curative chemoradiotherapy, including gemcitabine and cisplatin induction chemotherapy, intensity-modulated radiotherapy, and concurrent cisplatin chemotherapy.
• Completion of the last radiation dose within 1 to 42 days before randomization
• Eastern Cooperative Oncology Group performance status ≤1.
• Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
• Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
• Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
• Patients must be informed of the investigational nature of this study and give written informed consent.
• Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.

You may not qualify if:

• Age \> 65 or \< 18.
• Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1×10e3 copies/ml or 200IU/ml
• Hepatitis C virus (HCV) antibody positive
• Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
• Has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
• Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed.
• Has a known history of interstitial lung disease.
• Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
• Is pregnant or breastfeeding.
• Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
• Has known allergy to large molecule protein products or any compound of camrelizumab.
• Has a known history of human immunodeficiency virus (HIV) infection.
• Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (11)

First People's Hospital of Foshan

Foshan, Guangdong, China

Location

Guangzhou Medical University Cancer Hospital

Guangzhou, Guangdong, 510060, China

Location

Panyu central hospital

Guangzhou, Guangdong, 510060, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

Xijing Hospital, Fourth Military Medical University

Xi’an, Shanxi, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Related Publications (2)

• Liang YL, Liu X, Shen LF, Hu GY, Zou GR, Zhang N, Chen CB, Chen XZ, Zhu XD, Yuan YW, Yang KY, Jin F, Hu WH, Xie FY, Huang Y, Han F, Tang LL, Mao YP, Lu LX, Sun R, He YX, Zhou YY, Long GX, Tang J, Chen LS, Zong JF, Jin T, Li L, Lin J, Huang J, Gong XY, Zhou GQ, Chen L, Li WF, Chen YP, Xu C, Lin L, Huang SH, Huang SW, Wang YQ, Huang CL, Feng HX, Hou M, Chen CH, Zheng SF, Li YQ, Hong SB, Jie YS, Li H, Yun JP, Zang SB, Liu SR, Lin QG, Li HJ, Tian L, Liu LZ, Zhao HY, Li JB, Lin AH, Liu N, Zhang Y, Guo R, Ma J, Sun Y. Adjuvant PD-1 Blockade With Camrelizumab for Nasopharyngeal Carcinoma: The DIPPER Randomized Clinical Trial. JAMA. 2025 May 13;333(18):1589-1598. doi: 10.1001/jama.2025.1132.

  PMID: 40079940 DERIVED

• Huang SW, Jiang W, Xu S, Zhang Y, Du J, Wang YQ, Yang KY, Zhang N, Liu F, Zou GR, Jin F, Wu HJ, Zhou YY, Zhu XD, Chen NY, Xu C, Qiao H, Liu N, Sun Y, Ma J, Liang YL, Liu X. Systemic longitudinal immune profiling identifies proliferating Treg cells as predictors of immunotherapy benefit: biomarker analysis from the phase 3 CONTINUUM and DIPPER trials. Signal Transduct Target Ther. 2024 Oct 23;9(1):285. doi: 10.1038/s41392-024-01988-w.

  PMID: 39438442 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jun Ma, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2018
• First Posted: February 9, 2018
• Study Start: July 2, 2018
• Primary Completion: February 6, 2024
• Study Completion: February 1, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: For 2 years started from 12 months after publication of the primary trial report.
• Access Criteria: Authoritative researchers who provide a methodologically sound proposal for individual participant data meta-analysis.

Locations

CN (11)