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Toripalimab plus chemotherapy as first-line treatment for recurrent and/or metastatic nasopharyngeal cancer: safety and activity in non-endemic population
EU CTIS ID: 2025-522472-85-00
What this study is testing
To determine the incidence of high-grade (CTCAE v 5.0 Grade 3 or higher), treatment-related, selected adverse events in patients with RM NPC regardless of EBV status treated with toripalimab plus chemotherapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
- Males and Females, 18 years of age or older.
- Histologically confirmed recurrent or metastatic NPC not amenable to local therapy with curative intent, regardless of Epstein Barr-Virus (EBV) status.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Patients have not received a prior line of systemic therapy for R/M NPC.
You likely can't join if
- Allergy to monoclonal antibodies, any toripalimab components, gemcitabine, cisplatin and other platinum drugs.
- Patients with untreated, symptomatic CNS metastases.
- 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.
- 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.
- 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.
- Pregnancy or breastfeeding.
See the full eligibility criteria
- 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.
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
- Males and Females, 18 years of age or older.
- Histologically confirmed recurrent or metastatic NPC not amenable to local therapy with curative intent, regardless of Epstein Barr-Virus (EBV) status.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Patients have not received a prior line of systemic therapy for R/M NPC.
- Measurable disease by CT or MRI per RECIST 1.1 criteria.
- Documentation of EBER-positive or EBER-negative status at diagnosis and EBV DNA plasmatic levels.
- Allergy to monoclonal antibodies, any toripalimab components, gemcitabine, cisplatin and other platinum drugs.
- Patients with untreated, symptomatic CNS metastases.
- 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.
- 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.
- 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.
- Pregnancy or breastfeeding.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.