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

Status
Active
Cancer Type
Head and Neck Cancer
Trial Phase
Phase IV
Eligibility
12 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06457503
Protocol IDs
CHS-007-01/RTOG 3521 (primary)
NCI-2024-05550
Study Sponsor
Coherus Biosciences, Inc.

Summary

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

Objectives

The primary objective of this study is to evaluate the efficacy of toripalimab in
combination with chemotherapy (cisplatin and gemcitabine), as measured by objective
response rate (ORR) assessed by a Blinded Independent Central Review Committee (BICR)
according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in first-line
recurrent metastatic nasopharyngeal cancer participants (both Epstein-Barr virus (EBV)
and non-EBV-associated).

Eligibility

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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.