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)

Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Study ID
NCT06170489
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JS004 in combination with Toripalimab — BIOLOGICAL
    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 — DRUG
    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 Details

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)

Key Dates

First listed
Dec 14, 2023
Start date
Dec 28, 2023
Status verified
Feb 2025
Primary completion
May 31, 2025
Completion
Sep 30, 2027

Study Design

Enrollment
185 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC) [ Time Frame: Up to approximately 36 months ]

Central Contacts

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