A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
12 Years and older, Male and Female
CHS-007-01/RTOG 3521 (primary)
NCI-2024-05550
Summary
This study aims to investigate toripalimab with chemotherapy in participants with
nasopharyngeal cancer.
Objectives
The primary objective of this study is to evaluate the efficacy of toripalimab in
combination with chemotherapy (cisplatin and gemcitabine), as measured by objective
response rate (ORR) assessed by a Blinded Independent Central Review Committee (BICR)
according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in first-line
recurrent metastatic nasopharyngeal cancer participants (both Epstein-Barr virus (EBV)
and non-EBV-associated).
Eligibility
- Histological or cytological confirmation of recurrent/metastatic nasopharyngeal cancer with either EBV or non-EBV-associated cancer. The following subgroups are included:
- EBER/EBV-negative (HPV+/-)
- EBER/EBV-positive (HPV+/-)
- Recurrent/metastatic (stage IV-B as defined by the International Union against Cancer [UICC] and American Joint Committee on Cancer [AJCC] staging system for nasopharyngeal cancer [NPC], eighth edition) or recurrent NPC after curative treatment. For recurrent NPC, more than 6 months between the last dose of radiotherapy or chemotherapy and the date of recurrence.
- Measurable disease based on RECIST v 1.1 as determined by the site. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Key
Treatment Sites in Georgia
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