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

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• Disease that is suitable for local therapy administered with curative intent.
• Prior systemic therapy administered in the recurrent or metastatic setting. Participants who develop disease recurrence within 6 months from curative intent chemoradiation will be excluded.
• Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.
• Active or untreated central nervous system (CNS) metastases (e.g., brain or leptomeningeal), as determined on computerized tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments. Participants who have prior therapies for brain or leptomeningeal metastasis and have been stabilized ≥ 1 month and have discontinued systemic steroid therapy (>10 mg/day prednisone or equivalent) ≥ 1 month prior to enrollment are eligible. Other protocol-defined inclusion and exclusion criteria apply.

Where this trial is running

• 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

+ 1 more sites.

Who to contact

Clinical Operations Team Clinical Operations · 800-794-5434 · clinicaltrials@coherus.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06457503.