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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JS004 in combination with Toripalimab, Bendamustine or gemcitabine.
- Who it may be relevant to
- Registry conditions: Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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 with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL). The study will assess the safety and tolerability of JS004 combined with Toripalimab.
Interventions
- Biological JS004 in combination with Toripalimab
Participants will receive JS004 in combination with Toripalimab (200 mg/240 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions. - Drug Bendamustine or gemcitabine
Participants will receive Investigator-Selected chemotherapy of EITHER bendamustine by IV infusion at a dose of 90 or 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose of 1000 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.
Primary outcome measures
- Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC) [Time frame: Up to approximately 36 months]
Secondary outcome measures (8)
- Overall Survival (OS) [Time frame: Up to approximately 45 months]
- Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator [Time frame: Up to approximately 36 months]
- Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator [Time frame: Up to approximately 36 months]
- Complete response rate (CRR) per Lugano criteria 2014 Assessed by Investigator [Time frame: Up to approximately 36 months]
- Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator [Time frame: Up to approximately 36 months]
- Incidence and severity of all adverse events (AE) that occurred during the clinical trial [Time frame: Up to approximately 36 months]
- PK [Time frame: Up to approximately 36 months]
- Immunogenicity profiles [Time frame: Up to approximately 36 months]
Eligibility criteria
Inclusion criteria
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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT06170489 · JS004-009-III-cHL