NCT06457503 A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
| NCT ID | NCT06457503 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Coherus Oncology, Inc. |
| Condition | Nasopharyngeal Cancer Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-11-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
Eligibility 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.
Contact & Investigator
Study Director
STUDY DIRECTOR
Coherus Oncology
Frequently Asked Questions
Who can join the NCT06457503 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Nasopharyngeal Cancer Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06457503 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06457503 currently recruiting?
Yes, NCT06457503 is actively recruiting participants. Contact the research team at clinicaltrials@coherus.com for enrollment information.
Where is the NCT06457503 trial being conducted?
This trial is being conducted at Little Rock, United States, Irvine, United States, San Francisco, United States, Atlanta, United States and 9 additional locations.
Who is sponsoring the NCT06457503 clinical trial?
NCT06457503 is sponsored by Coherus Oncology, Inc.. The principal investigator is Study Director at Coherus Oncology. The trial plans to enroll 100 participants.
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