RecruitingPhase 2NCT06093061

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

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


Sponsor

National Cancer Centre, Singapore

Enrollment

53 participants

Start Date

Jul 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a maintenance treatment approach for patients with high-risk, locally advanced nasopharyngeal carcinoma (a cancer at the back of the nose and throat). After completing standard treatment, patients receive tislelizumab (an immunotherapy) plus low-dose capecitabine (an oral chemotherapy) to help prevent the cancer from coming back. **You may be eligible if...** - You are 21 years or older - You have been diagnosed with locally advanced nasopharyngeal carcinoma considered to be high-risk - You have completed standard chemoradiation treatment - You are in reasonably good health (ECOG 0-1) - Women of childbearing age must use highly effective contraception and have a negative pregnancy test **You may NOT be eligible if...** - You have previously received an anti-PD-1 or anti-PD-L1 immunotherapy - You have serious autoimmune disease, active infections, or uncontrolled medical conditions - You are pregnant or breastfeeding - You have significant liver, kidney, or heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTCCRT with Maintenance Tislelizumab and Metronomic Capecitabine

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).


Locations(2)

National Cancer Centre Singapore

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

View Full Details on ClinicalTrials.gov

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NCT06093061


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