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)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
185
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.
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.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGProgression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC)
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.
Time frame: Up to approximately 36 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 45 months
Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 assessed by Investigator or death due to any cause, whichever occurs first.
Time frame: Up to approximately 36 months
Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) 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
Complete response rate (CRR) is defined as the proportion of subjects in which BoR is CR, best overall response (BoR) refers to the best response as determined by the investigator.
Time frame: Up to approximately 36 months
Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator
For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by Investigator, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
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Time frame: Up to approximately 36 months
Incidence and severity of all adverse events (AE) that occurred during the clinical trial
An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number and sverity of participants who experience an AE will be presented.
Time frame: Up to approximately 36 months
PK
To characterize the trough concentrations of JS004 and toripalimab;
Time frame: Up to approximately 36 months
Immunogenicity profiles
To characterize incidence and titer of antidrug antibodies (ADA) and/or neutralizing antibodies (Nab);
Time frame: Up to approximately 36 months