Find Nasopharyngeal Carcinoma Clinical Trials Near You
Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
California
University of California, Irvine
RECRUITING
Irvine
University of California, San Francisco
RECRUITING
San Francisco
Georgia
Emory Winship Cancer Institute
RECRUITING
Atlanta
Massachusetts
Boston Medical Center
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Cancer Center
RECRUITING
Detroit
New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
WITHDRAWN
New York
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
Penn State Milton S. Hershey Medical Center
RECRUITING
Hershey
Wisconsin
Froedtert Hospital and the Medical College of Wisconsin
Participants will receive the triple combination of cisplatin, gemcitabine and toripalimab (Chemotherapy-based treatment phase) followed by single-agent toripalimab (Maintenance treatment phase). The use of cisplatin can be substituted with carboplatin from cycle 2 onwards.