A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants
Coherus Oncology, Inc.
100 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
Summary
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria4
- 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.
Interventions
Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
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.
Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.
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.
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT06457503