RecruitingPhase 4NCT06457503

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

Sponsor

Coherus Oncology, Inc.

Enrollment

100 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Cancer Recurrent

Summary

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

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding toripalimab (an immunotherapy drug) to standard chemotherapy (cisplatin + gemcitabine) works better than chemotherapy alone for people with recurrent or metastatic nasopharyngeal cancer — a type of throat cancer that has come back or spread. **You may be eligible if...** - You have histologically confirmed recurrent or metastatic nasopharyngeal cancer - Your cancer has returned after prior treatment or has spread to distant sites (stage IV-B) - Your cancer may be EBV-positive or EBV-negative (both types are included) **You may NOT be eligible if...** - You have not had prior treatment for localized disease - Your overall health does not meet the study's performance and organ function requirements - Other medical conditions make you ineligible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab

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.

DRUGCisplatin

Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.

DRUGGemcitabine

Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.

DRUGCarboplatin

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

View Full Details on ClinicalTrials.gov

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NCT06457503