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NCT Number: NCT06170489

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)

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)

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Location contact

Jun Huang

CONTACT

[email protected]

010-88196023

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC)

    Time frame: 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 outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 45 months

    OS is defined as the time from randomization to death due to any cause.

  2. Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator

    Time frame: 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.

  3. Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator

    Time frame: 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

  4. Complete response rate (CRR) per Lugano criteria 2014 Assessed by Investigator

    Time frame: 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.

  5. Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator

    Time frame: 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.

  6. Incidence and severity of all adverse events (AE) that occurred during the clinical trial

    Time frame: 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.

  7. PK

    Time frame: Up to approximately 36 months

    To characterize the trough concentrations of JS004 and toripalimab;

  8. Immunogenicity profiles

    Time frame: Up to approximately 36 months

    To characterize incidence and titer of antidrug antibodies (ADA) and/or neutralizing antibodies (Nab);

Study contacts

Contact information is provided by the study sponsor or research team.

Yuqin Song, Ph.D

CONTACT

[email protected]

010-88196118

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Dec 14, 2023
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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