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

Launched by NATIONAL CANCER CENTRE, SINGAPORE · Oct 16, 2023

Keywords

ClinConnect Summary

This clinical trial, named RIBBON-LA-01, is studying the effects of a combination treatment using a drug called tislelizumab and a low-dose chemotherapy called metronomic capecitabine in patients with high-risk nasopharyngeal carcinoma (a type of throat cancer). Specifically, it focuses on patients whose tests show they still have detectable levels of a virus (Epstein-Barr virus) after receiving initial chemotherapy. The goal is to see if this combination treatment can help keep the cancer from coming back after standard treatment.

To participate in this trial, patients must be at least 21 years old and able to provide consent, which means they understand the study and agree to follow its requirements. They should also have a good general health status and not be pregnant or planning to become pregnant during the study. Participants will receive treatment for a year, and they can expect regular check-ups to monitor their health and how well the treatment is working. It's important to know that this study is looking for specific patients who have not responded completely to their initial treatment, so not everyone with nasopharyngeal carcinoma will qualify.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
• • 2. Age ≥21 years on the day of signing the ICF
• • 3. ECOG Performance Status ≤1
• • 4. 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
• • 5. 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
• Exclusion Criteria:
• • 1. 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)
• • 2. Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including investigational agents for NPC
• • 3. Any known central nervous system metastases and/or carcinomatous meningitis
• • 4. 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:
• • 1. Controlled Type I diabetes
• • 2. Hypothyroidism (provided it is managed with hormone replacement therapy only)
• • 3. Controlled celiac disease
• • 4. Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
• • 5. Any other disease that is not expected to recur in the absence of external triggering factors
• • 5. 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)
• • 6. 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:
• • 1. Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)
• • 2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
• • 3. 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)
• • 7. 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
• • 8. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
• • 9. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
• • 1. Severe infections within 4 weeks before start of study, including but not limited to hospitalization for complications of infection, bactiraemia, or severe pneumonia.
• • 2. Received therapeutic oral or intravenous antibiotics within 2 weeks before start of study.
• • 10. A known history of HIV infection
• • 11. 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
• • 12. Any major surgical procedure requiring general anaesthesia ≤28 days before start of study
• • 13. Prior allogeneic stem cell transplantation or organ transplantation
• 14. Any of the following cardiovascular risk factors:
• • 1. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤28 days before start of study
• • 2. Pulmonary embolism ≤28 days before start of study
• • 3. Any history of acute myocardial infarction ≤6 months before start of study
• • 4. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV ≤6 months before start of study
• • 5. Any event of ventricular arrhythmia ≥Grade 2 in severity ≤6 months before start of study
• • 6. Any history of cerebrovascular accident ≤6 months before start of study
• • 7. Uncontrolled hypertension: systolic pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite anti-hypertension medications ≤28 days before start of study
• • 8. Any episode of syncope or seizure ≤28 days before start of study
• • 15. A history of severe hypersensitivity reactions to tislelizumab, gemcitabine, cisplatin, capecitabine and/or any of its excipients
• • 16. Has received any herbal medicine used to control cancer within 14 days of the start of study
• • 17. 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)
• • 18. 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
• • 19. 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
• • 20. Concurrent participation in another therapeutic clinical study