Status:
RECRUITING
A Phase III Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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)
Detailed Description
The study is a randomized, open-label, phase III clinical trial. The main objective is to compare the efficacy of JS004 plus Toripalimab with Investigator-Selected Chemotherapy in treating patients wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Known allergy or contraindication to the investigational drug or its components
- Permanent discontinuation of anti-PD-(L)1 antibody due to immune-related adverse reactions.
- Presence of central nervous system (CNS) metastasis.
- Presence of pleural effusion, ascites, or pericardial effusion requiring intervention (e.g., aspiration, drainage)
- Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years
Key Trial Info
Start Date :
December 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT06170489
Start Date
December 28 2023
End Date
September 30 2027
Last Update
February 28 2025
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142