Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma

NCT06093061 | Recruiting Phase 2

• 1 other identifier: RIBBON-LA-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Locoregionally-advanced NPC; EBV DNA; Concurrent chemoradiotherapy (CCRT); Maintenance Tislelizumab; Metronomic Capecitabine

Outcome Measures

Primary Outcomes (1)

• 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.

  2 Years.

Secondary Outcomes (3)

• 3-year Overall Survival (OS).

  3 years.

• Distant Metastasis-Free Survival (DMFS).

  2 years.

• Loco-Regional Recurrence-Free Survival (LRRFS).

  2 years.

Study Arms (1)

MAINTENANCE STUDY TREATMENT

EXPERIMENTAL

EBV DNA ≥4000 copies/mL OR N3 OR T4N+ (TNM AJCC/UICC 8th edition) AND EBV DNA detectable after 3 cycles of IC.

Combination Product: CCRT with Maintenance Tislelizumab and Metronomic Capecitabine

Interventions

CCRT with Maintenance Tislelizumab and Metronomic Capecitabine COMBINATION_PRODUCT

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).

MAINTENANCE STUDY TREATMENT

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ECOG Performance Status ≤1
• Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥120 days after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤7 days of start of trial
• Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥120 days after the last dose of tislelizumab

You may not qualify if:

• 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
• Note: Patients with the following diseases are not excluded and may proceed to further screening:
• Controlled Type I diabetes
• Hypothyroidism (provided it is managed with hormone replacement therapy only)
• Controlled celiac disease
• Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
• Any other disease that is not expected to recur in the absence of external triggering factors
• Any active malignancy ≤2 years before start of study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast). Patients with a history of other malignancies may be eligible if both the Principal Investigator and the Investigator Sponsor or designee have assessed and documented that the patient has a low risk of relapse requiring no further treatment, and that participation in the clinical trial will not increase the patient's risk profile
• Any condition that required systemic treatment with either corticosteroids (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before start of study
• Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
• Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)
• Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Tan Tock Seng Hospital: collaborator
• BeOne Medicines Singapore Pte. Ltd.: collaborator

Study Sites (2)

National Cancer Centre Singapore

Singapore, 168583, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Melvin LK CHUA, MBBS, FRCR, PhD, FAMS, FASCO

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melvin LK CHUA, MBBS, FRCR, PhD, FAMS, FASCO

CONTACT

+65 64368000; melvin.chua.l.k@singhealth.com.sg

Enya HW ONG

CONTACT

+65 9674 7899; enya.ong.h.w@nccs.com.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: July 3, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

SG (2)