Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants
Coherus Oncology, Inc.
Summary
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
Description
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
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * 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 chemot…
Interventions
- DrugToripalimab
Participants will receive toripalimab via intravenous infusion (IV) on Day 1 every 3 weeks (Q3W) during the Chemotherapy-based treatment phase and Maintenance treatment phase.
- DrugCisplatin
Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
- DrugGemcitabine
Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.
- DrugCarboplatin
In the event of cisplatin-related nephrotoxicity or at the discretion of the investigator due to cisplatin-related poor tolerability, carboplatin can substitute for cisplatin use from cycle 2 onward. These participants will receive carboplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
Locations (13)
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- University of California, IrvineIrvine, California
- University of California, San FranciscoSan Francisco, California
- Emory Winship Cancer InstituteAtlanta, Georgia
- Boston Medical CenterBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan