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)

Официальное название

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)

Обзор

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)

Подробное описание

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.

Вмешательства

• Биопрепарат JS004 in combination with Toripalimab
  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.
• Препарат Bendamustine or gemcitabine
  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.

Первичные конечные точки

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

Вторичные конечные точки (8)

• Overall Survival (OS) [Срок оценки: Up to approximately 45 months]
• Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator [Срок оценки: Up to approximately 36 months]
• Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator [Срок оценки: Up to approximately 36 months]
• Complete response rate (CRR) per Lugano criteria 2014 Assessed by Investigator [Срок оценки: Up to approximately 36 months]
• Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator [Срок оценки: Up to approximately 36 months]
• Incidence and severity of all adverse events (AE) that occurred during the clinical trial [Срок оценки: Up to approximately 36 months]
• PK [Срок оценки: Up to approximately 36 months]
• Immunogenicity profiles [Срок оценки: Up to approximately 36 months]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT06170489 · JS004-009-III-cHL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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