Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT02605967
Eligibility Criteria:
Inclusion Criteria:
* Histologically documented non-keratinizing locally advanced recurrent or metastatic NPC.
* Must be resistant to platinum-based chemotherapy (defined as progression on or after platinum-based chemotherapy given in the recurrent/metastatic setting).
* May have received at least 1 prior therapy for recurrent or metastatic disease, up to 2 prior systemic therapies.
* An archival tumor specimen or newly obtained tumor sample may be submitted at screening/baseline (a fresh tumor sample is preferred), unless agreed differently between Novartis and the Investigator.
* At least 1 measurable lesion (as per RECIST v1.1) progressing or new since last anti-tumor therapy.
* Prior treated brain or meningeal metastases must be without MRI evidence of progression for at least 8 weeks and off systemic steroids for at least 2 weeks prior to screening/baseline.
* Patient must be willing to undergo testing for human immunodeficiency virus (HIV) if not tested within the past 6 months. If HIV+ positive, patient will be eligible if: his/ her CD4+ count ≥ 300/μL; his/her viral load is undetectable; he/she is currently receiving highly active antiretroviral therapy (HAART).
Exclusion Criteria:
* History of severe hypersensitivity reactions to other mAbs
* Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators.
* Active HBV or HCV infections requiring therapy.
* Prior PD-1- or PD-L1-directed therapy or any therapeutic cancer vaccine.
* Patients receiving systemic treatment with any immunosuppressive medication.
* Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02605967
Study Brief:
Protocol Section:
NCT02605967