TRANSPARENT: Single-Arm Study of Toripalimab in Combination with Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naive Participants
Objective
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 RECIST v1.1 in first-line recurrent metastatic nasopharyngeal cancer participants (both EBV and non-EBV-associated).
The key secondary objectives of this study is to evaluate efficacy of toripalimab in combination with chemotherapy, as measured by the ORR assessed by the Investigator according to RECIST v1.1.
Other secondary objectives include: To evaluate efficacy of toripalimab in combination with chemotherapy, as measured by the duration of response (DoR) assessed by the investigator according to RECIST v1.1. To evaluate efficacy of toripalimab in combination with chemotherapy, as measured by progression-free survival (PFS) assessed by both BICR and Investigator according to RECIST v1.1. To evaluate efficacy of toripalimab in combination with chemotherapy, as measured by OS due to any causes. To evaluate efficacy of toripalimab in combination with chemotherapy, as measured by the disease control rate (DCR) assessed by both BICR committee and the Investigator according to RECIST v1.1. To evaluate efficacy of toripalimab in combination with chemotherapy, as measured by the both BICR committee and Investigator-assessed landmark PFS rate at 1 year and 2 years. To evaluate the safety of toripalimab in combination with chemotherapy, as measured by the frequency, severity, and drug relationship of adverse events (AEs), and Serious AEs (SAEs), and immunogenicity. To evaluate the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against toripalimab and their impact on pharmacokinetics, efficacy and safety of toripalimab. To characterize the pharmacokinetic (PK) profile of toripalimab (sparse PK) and evaluate the drug exposure response relationship for efficacy and safety.
