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)
JS004 in combination with ToripalimabBendamustine or gemcitabine
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.
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC) — Up to approximately 36 months PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by IRC or death due to any cause, whichever occurs first.
Trial sites (1)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
More Shanghai Junshi Bioscience Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.