Combining Toripalimab with Chemotherapy for Recurrent Nasopharyngeal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of toripalimab, a PD-1 inhibitor, when used alongside chemotherapy agents cisplatin and gemcitabine in patients with recurrent metastatic nasopharyngeal cancer. The primary goal is to assess the objective response rate (ORR) through evaluations conducted by a Blinded Independent Central Review Committee, following established criteria for solid tumors. Participants include those with both Epstein-Barr virus (EBV) and non-EBV-associated nasopharyngeal cancer, ensuring a comprehensive approach to treatment. The study aims to provide insights into the potential benefits of this combination therapy in a challenging cancer type.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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 it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• University of California, Irvine
  Irvine, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Emory Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Boston Medical Center
  Boston, Massachusetts, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Study coordinator: Clinical Operations Team Clinical Operations
• Email: clinicaltrials@coherus.com
• Phone: 800-794-5434

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.