A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- Coherus Oncology, Inc.
- Study ID
- NCT06457503
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Nasopharyngeal Cancer Recurrent
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Toripalimab — DRUGParticipants 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 — DRUGParticipants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
- Gemcitabine — DRUGParticipants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.
- Carboplatin — DRUGIn 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.
Study Details
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
Key Dates
- Start date
- Nov 1, 2024
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Toripalimab + cisplatin (or carboplatin) + gemcitabineParticipants 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.
Primary Outcome Measure
Objective Response Rate (ORR) assessed by a Blinded Independent Central Review (BICR) Committee according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 [ Time Frame: Up to 24 months ]
Central Contacts
- Clinical Operations Team Clinical Operations800-794-5434
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | Constance Brown Santanu Samanta, MD (PRINCIPAL_INVESTIGATOR) |
| University of California, Irvine | Irvine | California | 92697 | Shirin Attarian Bao-An Huynh (PRINCIPAL_INVESTIGATOR) |
| University of California, San Francisco | San Francisco | California | 94115 | Luchia Andemicael Brittany Liu Sue S Yom, MD (PRINCIPAL_INVESTIGATOR) |
| Emory Winship Cancer Institute | Atlanta | Georgia | 30322 | Madison Stallings Dong Shin, MD (PRINCIPAL_INVESTIGATOR) |
| Boston Medical Center | Boston | Massachusetts | 02118 | Peter C Everett, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | Cancer Answer Line 800-865-1125 Paul Swiecicki, MD (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Cancer Center | Detroit | Michigan | 48202 | Matthew Wilkins, MD (PRINCIPAL_INVESTIGATOR) |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | - |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | Audrey Romano Trisha M Wise-Draper, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Bridget Bush Tamara Sussman, MD (PRINCIPAL_INVESTIGATOR) |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | Danh Pham, MD (PRINCIPAL_INVESTIGATOR) |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Sarah Kaehny Stuart Wong, MD (PRINCIPAL_INVESTIGATOR) |