Clinical trial NCT03427827: PD-1 Antibody Versus Best Supportive Care After Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Neoplasms
Keywords: PD-1 antibody
Adjuvant treatment
Immune checkpoint inhibitors
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: failure-free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: distant metastasis-free survival
timeFrame: 3 years
measure: locoregional recurrence-free survival
timeFrame: 3 years
measure: adverse events (AEs) and severe adverse events (SAE)
timeFrame: 3 years
measure: quality of life (QoL)
timeFrame: 3 years
Other outcomes:
Locations:
city: Foshan
country: China
facility: First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Medical University Cancer Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Panyu central hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Cancer Hospital of Guangxi Medical University
state: Guangxi
city: Guiyang
country: China
facility: Cancer Hospital of Guizhou Medical University
state: Guizhou
city: Wuhan
country: China
facility: Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Sun Yat-sen University
name: Jun Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: