NCT06170489RecruitingPhase 3
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)
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)
Source: ClinicalTrials.gov · Last updated 28 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 185 (estimated)
- First submitted
- 6 Dec 2023
- Start date
- 28 Dec 2023
- Primary completion date
- 31 May 2025
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Diseases
- Hodgkin lymphoma
- NCT number
- NCT06170489
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 185
- From 28 Dec 2023 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years
Other
- Presence of central nervous system (CNS) metastasis.
- Presence of pleural effusion, ascites, or pericardial effusion requiring intervention (e.g., aspiration, drainage)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.