TORIPALIMAB for Nasopharyngeal carcinoma (recurrent/metastatic)

Inclusion criteria

• {"criterion_text":"-Subjects must have signed and dated an IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care."}
• {"criterion_text":"-Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study."}
• {"criterion_text":"-Males and Females, 18 years of age or older."}
• {"criterion_text":"-Histologically confirmed recurrent or metastatic NPC not amenable to local therapy with curative intent, regardless of Epstein Barr-Virus (EBV) status."}
• {"criterion_text":"-Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2."}
• {"criterion_text":"-Patients have not received a prior line of systemic therapy for R/M NPC."}
• {"criterion_text":"-Measurable disease by CT or MRI per RECIST 1.1 criteria."}
• {"criterion_text":"-Documentation of EBER-positive or EBER-negative status at diagnosis and EBV DNA plasmatic levels."}

Exclusion criteria

• {"criterion_text":"-Allergy to monoclonal antibodies, any toripalimab components, gemcitabine, cisplatin and other platinum drugs."}
• {"criterion_text":"-Patients with untreated, symptomatic CNS metastases."}
• {"criterion_text":"-Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results."}
• {"criterion_text":"-Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways."}
• {"criterion_text":"-Prior malignancy within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast."}
• {"criterion_text":"-Pregnancy or breastfeeding."}
• {"criterion_text":"-Subjects with active, known or suspected autoimmune disease. Subjects with experienced GVH disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition or previous neck RT only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll."}

Primary endpoints

• {"endpoint_text":"-Incidence of high-grade (CTCAE v 5.0 grade 3 or higher), treatment related adverse events","definition_or_measurement_approach":"Incidence of high-grade (CTCAE v 5.0 grade 3 or higher) treatment-related adverse events; assessed using CTCAE v5.0 criteria."}

Secondary endpoints

• {"endpoint_text":"-Incidence of all high-grade (Grades 3-5), selected adverse events, independently from the association with the study drugs;","definition_or_measurement_approach":"Incidence of selected high-grade (Grades 3-5) adverse events regardless of attribution to study drugs."}
• {"endpoint_text":"-Median time to onset and median time to resolution (Grades 3-4) of selected adverse events (resolution of an AE is a subject experiencing complete resolution or improvement to the baseline grade for the AE);","definition_or_measurement_approach":"Median time to onset and median time to resolution for selected AEs (Grades 3-4); resolution defined as complete resolution or improvement to baseline grade."}
• {"endpoint_text":"-Safety and tolerability measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs such as pulmonary, gastrointestinal, skin, renal, hepatic, pancreatic, neurologic, endocrine, infusion-related, or hypersensitivity.","definition_or_measurement_approach":"Safety assessed by incidence of all AEs, treatment-related AEs, SAEs, deaths, lab abnormalities and selected AE categories as listed."}
• {"endpoint_text":"-Investigator-assessed Progression Free Survival (PFS) defined as radiological evidence of progression, significant clinical symptomatic progression, the need to introduce a non-study drug therapy or death from any cause.","definition_or_measurement_approach":"PFS defined as time to radiological progression, significant clinical symptomatic progression, initiation of non-study therapy, or death; assessed by investigator."}
• {"endpoint_text":"-Overall Survival defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive.","definition_or_measurement_approach":"Overall survival measured from first dose date to date of death; censoring at last known alive date for survivors."}

Italy

Earliest CTIS Part Ii Submission Date

15-09-2025

Latest Decision Or Authorization Date

08-01-2026

Processing Time Days

115

Number Of Sites

12

Number Of Participants

49

Primary sponsor

Full Name

Humanitas Mirasole S.p.A.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Contract research organisations

Name

Clinical Research Technology S.r.l.

Responsibilities

Sponsor duties codes: 1,12,5,6,7,8 (as listed in record)

Third parties

• {"country":"Italy","full_name":"Clinical Research Technology S.r.l.","duties_or_roles":"1,12,5,6,7,8","organisation_type":"Pharmaceutical company"}