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A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
Sponsor: Coherus Oncology, Inc.
Summary
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
Official title: Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-11-01
Completion Date
2027-12
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Toripalimab
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.
Cisplatin
Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
Gemcitabine
Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.
Carboplatin
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 Sciences
Little Rock, Arkansas, United States
University of California, Irvine
Irvine, California, United States
University of California, San Francisco
San Francisco, California, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Cancer Center
Detroit, Michigan, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Princess Margaret Cancer Centre
Toronto, Canada