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

Nasopharyngeal Neoplasms Clinical Trial

— DIPPER  

Official title:

Camrelizumab (PD-1 Antibody) Compared With Best Supportive Care After Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Randomised Controlled, Phase 3 Trial (DIPPER)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03427827
• Other study ID #: B2017-097-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 2, 2018
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this multicenter, randomised controlled, phase 3 trial, patients with stage III-IVA (AJCC/UICC 8th system, except T3-4N0 and T3N1) non-metastatic nasopharyngeal carcinoma will be randomized in a 1:1 ratio to recieve PD-1 antibody for 12 doses every 3 weeks or best supportive care after curative chemoradiation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: February 2026
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	First People's Hospital of Foshan	Foshan	Guangdong
China	Guangzhou Medical University Cancer Hospital	Guangzhou	Guangdong
China	Panyu central hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Cancer Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Cancer Hospital of Guangxi Medical University	Nanning	Guangxi
China	Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall survival	calculated from date of randomisation to death	5 years
Secondary	distant metastasis-free survival	calculated from date of randomisation to the first distant failure	3 years
Secondary	locoregional recurrence-free survival	calculated from date of randomisation to the first locoregional failure	3 years
Secondary	adverse events (AEs) and severe adverse events (SAE)	graded according to NCI CTCAE v5.0	3 years
Secondary	quality of life (QoL)	the change of QoL from randomization to 36 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0	3 years