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Back|NCT06457503Recruiting
Official Title

Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants

Phase
Phase 4
Sponsor
Coherus Oncology, Inc.
Enrollment
100
Timeline
Nov 2024 → Dec 2027
About This Study

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

Eligibility Criteria

Inclusion Criteria

  • 1Histological or cytological confirmation of recurrent/metastatic nasopharyngeal cancer with either EBV or non-EBV-associated cancer. The following subgroups are included:
  • 2EBER/EBV-negative (HPV+/-)
  • 3EBER/EBV-positive (HPV+/-)
  • 4Recurrent/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.
  • 5Measurable 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 Criteria

  • 1Disease that is suitable for local therapy administered with curative intent.
  • 2Prior systemic therapy administered in the recurrent or metastatic setting. Participants who develop disease recurrence within 6 months from curative intent chemoradiation will be excluded.
  • 3Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.
  • 4Active 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.

Locations

11 sites participating in this study

Emory Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Dong Shin, MD

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205

Recruiting

Santanu Samanta, MD

University of California, Irvine

Irvine, California 92697

Recruiting

Bao-An Huynh

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →