Combining Toripalimab with Chemotherapy for Recurrent Nasopharyngeal Cancer
Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants
This study is testing if combining a new drug called toripalimab with chemotherapy can help people with recurrent nasopharyngeal cancer feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Coherus Oncology, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, prednisone, toripalimab |
| Locations | 13 sites (Little Rock, Arkansas and 12 other locations) |
| Trial ID | NCT06457503 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with histologically confirmed recurrent or metastatic nasopharyngeal cancer, either EBV-positive or negative, who have measurable disease.
Not a fit: Patients whose disease is suitable for local therapy with curative intent or those who have received prior systemic therapy for recurrence may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve response rates and outcomes for patients with recurrent metastatic nasopharyngeal cancer.
How similar studies have performed: Previous studies involving PD-1 inhibitors in combination with chemotherapy have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Little Rock, Arkansas and 12 other locations
- 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)
- Henry Ford Cancer Center — Detroit, Michigan, United States (Recruiting)
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (Withdrawn)
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
- Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Canada (Recruiting)
Study contacts
- Study coordinator: Clinical Operations Team Clinical Operations
- Email: clinicaltrials@coherus.com
- Phone: 800-794-5434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.