Abstract 247TiP
Background
Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Despite the most aggressive and devastating treatment with induction chemotherapy followed by concurrent chemoradiation, about 20-30% of patients with locoregionally advanced nasopharyngeal carcinoma (LANPC) suffer from relapse at 5 years. Addition of anti-PD(L)1 immune checkpoint inhibitor to this intensive radical treatment may help improve treatment outcomes and survival. We are conducting a phase II randomised-controlled trial on adding durvalumab as induction, concurrent and maintenance therapy to induction and concurrent chemoradiation compared to the same regimen without durvalumab for previously untreated LANPC patients.
Trial design
Patients with previously untreated LANPC (stage III to IVA disease except T3N0M0 based on TNM-8) are screened for study eligibility. After fulfilling all the study criteria, they will be randomised (in 1:1 ratio) to (a) experimental arm with a fixed dose durvalumab 1500mg intravenously administered every 4 weeks for 13 cycles and 3 cycles of induction chemotherapy with gemcitabine (1000mg/m2 on day 1 and day 8) and cisplatin (100mg/m2 on day 1) every 3 weeks followed by concurrent chemoradiation with 3-weekly cisplatin (100mg/m2) infusion, or (b) control arm with the same regimen of induction chemotherapy and concurrent chemoradiation. The primary study end point is progression-free survival while the secondary end points are objective response, overall survival, safety profiles, change in tumour microenvironment before and after induction chemotherapy and concurrent chemoradiation (with or without durvalumab), and change in PD-L1 positive circulating tumour cells before and after induction chemotherapy and concurrent chemoradiation (with or without durvalumab). The study is still ongoing and expected to complete patient accrual (n=118) in end of December 2022.
Clinical trial identification
NCT04447612. Release date: 25 June 2020.
Legal entity responsible for the study
Department of Clinical Oncology, LKS Faculty of Medicine, The University of Hong Kong.
Funding
AstraZeneca.
Disclosure
V.H.F. Lee: Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme, Amgen, Takeda, Bristol Myers Squibb, AstraZeneca, Roche; Financial Interests, Personal, Invited Speaker: Boston Scientific, Novartis, Merck Pharmaceuticals. All other authors have declared no conflicts of interest.
Resources from the same session
140P - Lenvatinib + everolimus in mRCC that has progressed on immunotherapy: A real-world single center experience
Presenter: CHINNU JOMI
Session: Poster viewing 03
141P - Real-world study of cabozantinib treatment of advanced renal cell carcinoma in Taiwan
Presenter: Yu-Chieh Tsai
Session: Poster viewing 03
143P - Clinical outcomes of systemic therapy for hemodialysis patients with metastatic renal cell carcinoma
Presenter: Shun Iwasa
Session: Poster viewing 03
144P - Association between immune-related adverse events and survival in metastatic renal cell carcinoma treated with nivolumab plus ipilimumab
Presenter: Takanori Hayase
Session: Poster viewing 03
145P - Treatment outcomes and FGFR alterations in unresectable locally advanced or metastatic urothelial cancer in Taiwan
Presenter: Jian-Ri Li
Session: Poster viewing 03
146P - Comparison of the survival outcomes between primary and secondary muscle-invasive bladder cancer: A propensity score-matched Chinese cohort
Presenter: WAICHAN LOK
Session: Poster viewing 03
Resources:
Abstract
147P - Activity of single-agent PD-1/PD-L1 inhibitors in 1st-line (1L) “platinum-ineligible” patients (pts) with metastatic urothelial cancer (mUC) in real-life clinical practice
Presenter: Javier Molina Cerrillo
Session: Poster viewing 03
149P - A need for clear definitions and improved management for BCG-unresponsive tumors in Asia-Pacific
Presenter: Lui Shiong Lee
Session: Poster viewing 03
Resources:
Abstract