QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.

Launched by SUN YAT-SEN UNIVERSITY · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with locoregionally-advanced nasopharyngeal carcinoma (NPC), which is a type of throat cancer. The trial is comparing a drug called QL1706, which targets cancer in two different ways, combined with standard chemotherapy and radiation therapy, against the standard treatment alone. The goal is to see if adding QL1706 can improve outcomes for patients with high-risk NPC.

To participate in the trial, patients need to be between 18 and 65 years old and have a confirmed diagnosis of NPC. They should have specific tumor characteristics and good overall health. Participants will receive the study treatment and will be closely monitored throughout the trial. It's important for potential participants to understand that they will need to give consent to be part of this research and may have to follow specific guidelines, such as using effective birth control if they are sexually active. This trial is currently looking for volunteers, and anyone interested should discuss it with their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Age ≥18 and ≤65 years
• • 2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
• • 3. Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th)
• • Stage II: T1-3N2
• • Stage III: T1-4N3, T4N1-2
• • 4. Eastern Cooperative Oncology Group performance score of 0-11.
• • 5. Adequate marrow function: white blood cell count \> 4 × 10⁹/Lhemoglobin \>90g/L and platelet count \>100×10⁹/L
• • 6. Adequate hepatic and renal function：
• • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
• • Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN
• • Alkaline phosphatase ≤ 2.5 × ULN
• • clearance rate ≥ 60 ml/min
• • 7. Other laboratory and clinical criteria
• • Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG)
• • For patients aged \>50 years with a history of smoking, normal pulmonary function test (PFT) results are required
• • For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits
• • 8. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.
• • 9. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).
• • Exclusion Criteria
• • 1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \>1×103 copies/mL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody
• • 2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
• • 3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received confirmed and regular anti-tuberculosis treatment.
• • 4. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.
• • 5. Thymic epithelial tumors (TETs), including thymoma, thymic carcinoma, and thymic neuroendocrine tumors (NETTs).
• • 6. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.
• • 7. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.
• 8. Uncontrolled cardiac conditions, such as:
• • Heart failure with New York Heart Association (NYHA) classification ≥ Class II;
• • Unstable angina;
• • History of myocardial infarction within the past year;
• • Supraventricular or ventricular arrhythmias requiring treatment or intervention
• • 9. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)
• • 10. History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
• • 11. Known hypersensitivity to macromolecule protein products or any component of QL1706.
• • 12. Active infections requiring systemic treatment within 1 week prior to enrollment.
• • 13. Administration of live vaccines within 30 days prior to the first dose of epalurilimab-tovorolimab.
• • 14. History of organ transplantation or hematopoietic stem cell transplantation.
• • 15. Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.