RTOGF Opens 'TRANSPARENT' Study for Patients with Nasopharyngeal Cancer

December 06, 2024

RTOG Foundation (RTOGF) recently opened the new ‘TRANSPARENT’ trial as part of the group’s head and neck cancer portfolio. CHS-007-01/RTOG 3521, otherwise known as the ‘TRANSPARENT’ study, is a single-arm trial designed to test the drug toripalimab in combination with cisplatin and gemcitabine for patients with recurrent, metastatic nasopharyngeal cancer that are also systemic treatment-naïve. This trial will be available to patients with both EBV-negative and EBV-positive as well as HPV-negative and HPV-positive disease.

“This trial is very important and unique in its potential to inform the first-line regimen in the North American population of recurrent, metastatic nasopharyngeal cancer. Additionally, it would be the first study aimed at defining the efficacy of the combination of anti-PD-1 with chemotherapy which, at this time, has not been confirmed in the North American setting,” stated Anna Spreafico, MD, PhD, of the Princess Margaret Cancer Centre and the Principal Investigator of the TRANSPARENT study.

The primary aim of this study is to determine if the addition of toripalimab to chemotherapy is efficacious in producing an objective response rate in patients. Additionally, researchers will be observing efficacy in duration of response. Other secondary objectives include the evaluation of progression-free survival, overall survival, disease control rate and adverse events in correlation with this chemo-immunotherapy treatment.

Patients enrolled to this study will receive up to 6 cycles of cisplatin and gemcitabine chemotherapy with the study drug toripalimab. Following chemotherapy, if there is no disease progression, patients will receive maintenance toripalimab for 29 cycles. Patients will receive treatment for a total of 24 months and will return for a follow up when treatment concludes.

This study will be available in the United States and Canada.

For questions regarding site enrollment to this study, please contact Robin Turton at rturton@acr.org or RTOG3521Regulatory@acr.org.

Site documents and materials are available behind a login here on the RTOG website.

This study is sponsored by Coherus BioSciences, Inc. in collaboration with RTOG Foundation.

 

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To participate as an RTOG study investigator, your organization must be part of the RTOG Foundation network. Patients who wish to participate in a study must be under the care of an RTOG participating investigator. For additional information, email info@rtog.org or call 1-215-574-3173.

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