This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Participants will receive toripalimab via intravenous infusion (IV) on Day 1 every 3 weeks (Q3W) during the Chemotherapy-based treatment phase and Maintenance treatment phase.
Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
RECRUITINGUniversity of California, Irvine
Irvine, California, United States
RECRUITINGObjective Response Rate (ORR) assessed by a Blinded Independent Central Review (BICR) Committee according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
Time frame: Up to 24 months
Duration of Response (DoR) assessed by BICR according to RECIST v1.1
Time frame: Up to 24 months
ORR assessed by the investigator according to RECIST v1.1
Time frame: Up to 24 months
DoR assessed by the investigator according to RECIST v1.1
Time frame: Up to 24 months
Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1
Time frame: Up to 24 months
PFS assessed by the investigator according to RECIST v1.1
Time frame: Up to 24 months
Overall Survival (OS) defined as time from enrollment to death due to any cause
Time frame: Up to 42 months
Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1
Time frame: Up to 24 months
DCR assessed by the investigator according to RECIST v1.1
Time frame: Up to 24 months
Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve
Time frame: 12 months, 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
In the event of cisplatin-related nephrotoxicity or at the discretion of the investigator due to cisplatin-related poor tolerability, carboplatin can substitute for cisplatin use from cycle 2 onward. These participants will receive carboplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
University of California, San Francisco
San Francisco, California, United States
RECRUITINGEmory Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGBoston Medical Center
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGLaura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
RECRUITINGUniversity of Cincinnati Medical Center
Cincinnati, Ohio, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGFroedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITING...and 1 more locations