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Clinical Trials in the USA / NCT06457503
Recruiting Phase 4

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

NCT06457503 · tracked via the Priya Life Science USA tracker
Sponsor
Coherus Oncology, Inc.
Phase
Phase 4
Started
2024-11-01
Last updated
2026-07-30

Condition(s) studied

Nasopharyngeal Cancer Recurrent

Investigational drug(s) / intervention(s)

Toripalimab →Cisplatin →Gemcitabine →Carboplatin →

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.

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

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

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.

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
University of California, Irvine Irvine California Recruiting
University of California, San Francisco San Francisco California Recruiting
Emory Winship Cancer Institute Atlanta Georgia Recruiting
Boston Medical Center Boston Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Henry Ford Cancer Center Detroit Michigan Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York New York Withdrawn
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania Recruiting
Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Princess Margaret Cancer Centre Toronto Canada Recruiting

More Coherus Oncology, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06457503 on ClinicalTrials.gov ↗ ← All trials in the USA