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RECRUITING
NCT06457503
PHASE4

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

Sponsor: Coherus Oncology, Inc.

View on ClinicalTrials.gov

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

Interventions

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.

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