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.
Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
Age ≥21 years on the day of signing the ICF
LA-NPC defined as AJCC/UICC 8th edition TNM-stage III-IVA
DETECTABLE EBV DNA levels following 3 cycles of IC, defined as >0 copies/mL
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including investigational agents for NPC, except for induction chemotherapy (Cisplatin and Gemcitabine) that was completed within the last 22 days. Subjects who have started on concurrent chemo-radiotherapy (CCRT; cisplatin with radiotherapy) following completion of induction chemotherapy (Cisplatin with Gemcitabine) are allowed to enroll
Any known central nervous system metastases and/or carcinomatous meningitis
Active autoimmune diseases or history of autoimmune diseases that may relapse
Single group
CCRT with Maintenance Tislelizumab and Metronomic Capecitabine
Combination productCCRT: 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).
2-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.
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.
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
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
Click on the lead sponsor to view all of their trials.
National Cancer Centre, Singapore
Lead sponsor
BeOne Medicines Singapore Pte. Ltd.
Collaborator
Tan Tock Seng Hospital
Collaborator
