Patients with "high-risk" locoregionally-advanced nasopharyngeal carcinoma (LA-NPC), defined as AJCC/UICC 8th edition TNM-stage III-IVA and high Epstein-Barr virus (EBV) DNA viral load (≥4,000 copies/mL) will require induction chemotherapy (IC) prior to chemo-radiation (CCRT) as per standard treatment. Patients who persist to manifest DETECTABLE EBV DNA following 3 cycles of IC have a higher risk of relapse, and are typically recommended for a year of low-dose oral chemotherapy after CCRT. RIBBON-LA-01 is a single-arm, open-label, phase 2 clinical trial of maintenance tislelizumab and metronomic capecitabine (metroCap) for 52 weeks after IC and CCRT, targeting this specific group of patients who have persistent detectable EBV DNA after IC. The main objective is to evaluate the efficacy of maintenance tislelizumab and metroCap in patients with DETECTABLE EBV DNA levels after 3 cycles of IC.
RIBBON-LA-01 is embedded in a modular platform trial concept (NCT05517135, https://clinicaltrials.gov/study/NCT05517135) that tests if EBV DNA-based risk stratification strategies for treatment individualization improves survival outcomes in LA-NPC. The overarching platform trial concept allocates patients with LA-NPC to treatment arms of different intensities by their plasma EBV DNA levels pre-treatment and post-IC. RIBBON-LA-01 enrolls patients allocated to Arm 3 of the platform trial; these are patients with pre-treatment EBV DNA of \>4,000 copies/mL OR N2-3 or T4N+ NPC who were treated with upfront IC, but persist to manifest DETECTABLE EBV DNA levels following 3 cycles of IC. Patients on the trial will be assigned to CCRT followed by a 12-month course of maintenance tislelizumab and metroCap. The primary endpoint of the study is two-year disease-free survival, measured as a binomial proportion of the number of patients who are alive and free of disease relapse at the end of 2 years after the start of treatment (defined as the time from start of IC) over the total number of eligible patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
CCRT: Radiotherapy will be delivered once daily, for 5 days per week, over 6 to 7 weeks. During RT, cisplatin will be administered either 100 mg/m2 3-weekly or 40 mg/m2 weekly, IV infusion (physician's choice). Maintenance: Tislelizumab 200mg, day 1 per 3-week cycle, intravenous (IV) infusion and capecitabine 650 mg/m2, days 1-21 per 3-week cycle, bidaily, oral, for a total of 12 months (17 cycles).
National Cancer Centre Singapore
Singapore, Singapore
RECRUITINGTan Tock Seng Hospital
Singapore, Singapore
RECRUITING2-year Disease-Free Survival (DFS) rate.
The proportion of patients who are alive and free of disease relapse at the end of 2 years after the start of Induction Chemotherapy (IC) for patients.
Time frame: 2 Years.
3-year Overall Survival (OS).
Time from date of start of treatment (IC) to death from any cause, where patients lost to follow-up were censored at the date of last follow-up.
Time frame: 3 years.
Distant Metastasis-Free Survival (DMFS).
Time from date of start of treatment (IC) to documented distant metastasis or death from any cause, patients with locoregional relapse as a first event will be censored at date of locoregional relapse
Time frame: 2 years.
Loco-Regional Recurrence-Free Survival (LRRFS).
Time from date start of treatment (IC) to documented locoregional relapse or death from any cause, patients with distant metastasis as a first event will be censored at the date of distant metastasis
Time frame: 2 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.