Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT06093061
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2023-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
Sponsor:
National Cancer Centre, Singapore
Organization:
Study Overview
Official Title:
RIBBON-LA-01: Single-arm, Open-label, Phase 2 Trial of Tislelizumab and Metronomic Capecitabine as Maintenance Therapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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.
Detailed Description:
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, defined as the proportion of patients who are alive and free of disease relapse at the end of 2 years after the start of treatment.
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, defined as the proportion of patients who are alive and free of disease relapse at the end of 2 years after the start of treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: