A Phase III, Randomised, Open-label,, Multi-Center Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1 Monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study is being conducted to compare JS004 plus Toripalimab with Investigator-Selected Chemotherapy in Patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Patients must meet all of the following inclusion criteria to be enrolled:
• Age at least 18 years old, both males and females are eligible
• Pathologically confirmed classical Hodgkin Lymphoma (cHL) with either relapsed (disease progression after achieving CR/PR in recent treatment) or refractory (failure to achieve CR/PR in recent treatment) status.
• Has exhausted all standard treatment and refractory to PD-(L)1 monoclonal antibody (mAb)
• ECOG: 0-2
• At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment.
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Yuqin Song, Ph.D
SongYQ_VIP@163.com
010-88196118
Time Frame
Start Date: 2023-12-28
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 185
Treatments
Experimental: JS004 plus Toripalimab
JS004 200mg plus Toripalimab 240mg IV on day 1 of each cycle, every 3 weeks for up to 2 years
Active_comparator: Investigator-Selected Chemotherapy
Bendamustine or gemcitabine
Related Therapeutic Areas
Sponsors
Leads: Shanghai Junshi Bioscience Co., Ltd.