NCT06457503

A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer

Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Coherus Oncology, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.

Detailed 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).

Conditions

• Nasopharyngeal Cancer Recurrent

Interventions

Type	Name	Description
DRUG	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.
DRUG	Cisplatin	Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
DRUG	Gemcitabine	Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.
DRUG	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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-06-13
• Last updated: 2026-04-06

Locations

13 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study