Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
Sponsor:
Coherus Biosciences Inc
Organization:
Coherus Biosciences Inc
Study Overview
Official Title:
Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSPARENT
Brief Summary:
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer
Detailed Description:
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 v11 in first-line recurrent metastatic nasopharyngeal cancer participants both Epstein-Barr virus EBV and non-EBV-associated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None