RTOG Foundation Trial Showcase: CHS-007-01/RTOG 3521

June 25, 2024

The CHS-007-01/RTOG 3521 trial, also known as the ‘TRANSPARENT” study, is currently recruiting sites for eventual patient enrollment onto the trial. This trial is a single-arm study 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 is available for patients with both EBV-negative and EBV-positive as well as HPV-negative and HPV-positive disease.

The primary aim of this study is to determine if the addition of  toripalimab to chemotherapy is more efficacious at improving objective response rate in patients. Additionally, researchers will be observing any improvement 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. The results of this study could provide a first-line regimen in North America for recurrent and/or metastatic nasopharyngeal cancer.

“As this is a rare patient population, the study budget for sites provides excellent startup and accrual support to cover administrative costs even in low accrual scenarios. Also, new guidelines at the NRG Oncology group level allow for between 1-7 RTOG Foundation accruals to be counted as NRG Oncology accrual credits depending on your membership level. We hope that all sites in North America will consider this study as it will be the only contemporary study that was designed and aimed at studying nasopharyngeal carcinoma in North America,” stated Anna Spreafico, MD, PhD of the Princess Margaret Cancer Centre and the Principal Investigator of the TRANSPARENT study.


This trial is aiming to accrue approximately 35 institutional sites in the United States and Canada.


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


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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