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

RecruitingPhase 4Ages 12 Years - anyAllCoherus Oncology, Inc.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 1 month and have discontinued systemic steroid therapy (\>10 mg/day prednisone or equivalent) โ‰ฅ 1 month prior to enrollment are eligible. Other protocol-defined inclusion and exclusion criteria apply.
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What it tests

  • Toripalimab
  • Cisplatin
  • Gemcitabine
  • Carboplatin
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Where

13 sites
University of Arkansas for Medical Sciences
Little Rock, United States
University of California, Irvine
Irvine, United States
University of California, San Francisco
San Francisco, United States
Emory Winship Cancer Institute
Atlanta, United States
Boston Medical Center
Boston, United States
University of Michigan
Ann Arbor, United States
Henry Ford Cancer Center
Detroit, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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