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)

Phase 3

Recruiting

• Conditions: Hodgkin Lymphoma
• Interventions: Biological: JS004 in combination with Toripalimab; Drug: Bendamustine or gemcitabine

• Registration Number: NCT06170489
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief 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)

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.

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Study Start: 2023-12-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-05-31
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JS004 plus Toripalimab	JS004 in combination with Toripalimab	JS004 200mg plus Toripalimab 240mg IV on day 1 of each cycle, every 3 weeks for up to 2 years
Investigator-Selected Chemotherapy	Bendamustine or gemcitabine	Bendamustine or gemcitabine

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 45 months	OS is defined as the time from randomization to death due to any cause.
Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator	Up to approximately 36 months	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.
Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator	Up to approximately 36 months	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
Complete response rate (CRR) per Lugano criteria 2014 Assessed by Investigator	Up to approximately 36 months	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.
Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator	Up to approximately 36 months	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.
Incidence and severity of all adverse events (AE) that occurred during the clinical trial	Up to approximately 36 months	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.
PK	Up to approximately 36 months	To characterize the trough concentrations of JS004 and toripalimab;
Immunogenicity profiles	Up to approximately 36 months	To characterize incidence and titer of antidrug antibodies (ADA) and/or neutralizing antibodies (Nab);

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China