Nasopharyngeal CarcinomaPhase 2NCT06093061
Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
A Phase 2 study testing CCRT with Maintenance Tislelizumab and Metronomic Capecitabine in people with Nasopharyngeal Carcinoma, run by National Cancer Centre, Singapore at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- CCRT with Maintenance Tislelizumab and Metronomic Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesSingapore
- Study dates
- 3 Jul 2024to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 40Show fewer
- 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
- Short course (≤7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)
- With uncontrolled diabetes or >Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥Grade 3 hypoalbuminemia ≤14 days before start of study
- With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
- With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
- Severe infections within 4 weeks before start of study, including but not limited to hospitalization for complications of infection, bactiraemia, or severe pneumonia.
- Received therapeutic oral or intravenous antibiotics within 2 weeks before start of study.
- A known history of HIV infection
- Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is >500 IU/mL or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA <500 IU/mL), and cured hepatitis C patients can be enrolled
- Any major surgical procedure requiring general anaesthesia ≤28 days before start of study
- Prior allogeneic stem cell transplantation or organ transplantation
- Any of the following cardiovascular risk factors:
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤28 days before start of study
- Pulmonary embolism ≤28 days before start of study
- Any history of acute myocardial infarction ≤6 months before start of study
- Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV ≤6 months before start of study
- Any event of ventricular arrhythmia ≥Grade 2 in severity ≤6 months before start of study
- Any history of cerebrovascular accident ≤6 months before start of study
- Uncontrolled hypertension: systolic pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite anti-hypertension medications ≤28 days before start of study
- Any episode of syncope or seizure ≤28 days before start of study
- A history of severe hypersensitivity reactions to tislelizumab, gemcitabine, cisplatin, capecitabine and/or any of its excipients
- Has received any herbal medicine used to control cancer within 14 days of the start of study
- Patients with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities)
- Was administered a live vaccine ≤4 weeks before start of study Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines, and are not allowed
- Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that, will be unfavourable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study conduct
- Concurrent participation in another therapeutic clinical study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
About this study
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
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.
Read the 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, 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.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- CCRT with Maintenance Tislelizumab and Metronomic Capecitabine
- Keywords
- Locoregionally-advanced NPC, EBV DNA, Concurrent chemoradiotherapy (CCRT), Maintenance Tislelizumab, Metronomic Capecitabine
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCRT with Maintenance Tislelizumab and Metronomic CapecitabineCombination 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: CCRT with Maintenance Tislelizumab and Metronomic Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Years.
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start3 Jul 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- BeOne Medicines Singapore Pte. Ltd., Tan Tock Seng Hospital
- Responsible party
- Sponsor
- Investigators
- Melvin LK CHUA, MBBS, FRCR, PhD, FAMS, FASCO, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093061
- Sponsor's protocol ID
- RIBBON-LA-01
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With BeOne.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06093061
- Acronym / sponsor ID
- RIBBON-LA-01
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Locoregionally-advanced NPC, EBV DNA, Concurrent chemoradiotherapy (CCRT), Maintenance Tislelizumab, Metronomic Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- BeOne Medicines Singapore Pte. Ltd., Tan Tock Seng Hospital
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAINTENANCE STUDY TREATMENT | Experimental | Combination Product: CCRT with Maintenance Tislelizumab and Metronomic CapecitabineEBV DNA ≥4000 copies/mL OR N3 OR T4N+ (TNM AJCC/UICC 8th edition) AND EBV DNA detectable after 3 cycles of IC. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (40 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCRT with Maintenance Tislelizumab and Metronomic CapecitabineCCRT: 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). | Combination product | MAINTENANCE STUDY TREATMENT |
Primary outcome
2-year Disease-Free Survival (DFS) rate.
Time frame: 2 Years.
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 secondary outcomes
3-year Overall Survival (OS).
Time frame: 3 years.
Distant Metastasis-Free Survival (DMFS).
Time frame: 2 years.
Loco-Regional Recurrence-Free Survival (LRRFS).
Time frame: 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes. With BeOne.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melvin LK CHUA, MBBS, FRCR, PhD, FAMS, FASCO principal investigator
National Cancer Centre, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CCRT with Maintenance Tislelizumab and Metronomic Capecitabine in people with Nasopharyngeal Carcinoma, run by National Cancer Centre, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melvin LK CHUA, MBBS, FRCR, PhD, FAMS, FASCO (+65 64368000, melvin.chua.l.k@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Disease-Free Survival (DFS) rate. (time frame: 2 Years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.