Clinical trial 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)
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hodgkin Lymphoma
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC)
timeFrame: Up to approximately 36 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 45 months
measure: Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator
timeFrame: Up to approximately 36 months
measure: Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator
timeFrame: Up to approximately 36 months
measure: Complete response rate (CRR) per Lugano criteria 2014 Assessed by Investigator
timeFrame: Up to approximately 36 months
measure: Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator
timeFrame: Up to approximately 36 months
measure: Incidence and severity of all adverse events (AE) that occurred during the clinical trial
timeFrame: Up to approximately 36 months
measure: PK
timeFrame: Up to approximately 36 months
measure: Immunogenicity profiles
timeFrame: Up to approximately 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: