Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of tislelizumab in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Progression-free Survival (PFS) as assessed by investigator

Official Title
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A Multicenter, Open-Label, Randomized Controlled Phase 3 Study of Tislelizumab Monotherapy Versus Salvage Chemotherapy in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Conditions
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Classical Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Tislelizumab
* Drug: Salvage Chemotherapy


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 1. Histologically confirmed cHL.Must have relapsed or refractory ( cHL and Has failed to achieve a response or progressed after autologous hematopoietic stem cell transplant (ASCT). or Has received at least two prior lines of systemic chemotherapies for cHL and is not an ASCT candidate. 2. Must have measurable disease 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Must have adequate organ functions. 5. Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy used to control cancer including locoregional treatment must have been completed ≥ 4 weeks before the first dose of study drug, and all treatment-related adverse events are stable and have either returned to baseline or Grade 0/1 Key Exclusion Criteria: Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma. Known central nervous system (CNS) lymphoma. Prior allogeneic hematopoietic stem cell transplant. ASCT or Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) within 100 days of first dose of study drug. Prior therapies targeting PD-1 or PD-L1. Prior malignancy within the past 3 years except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast. Participant with active autoimmune disease or history of autoimmune disease with high risk of recurrence. Serious acute or chronic infection requiring systemic therapy. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tislelizumab<br>Tislelizumab monotherapy for up to 45 months | Drug: Tislelizumab<br>* 200 mg administered via intravenous (IV) infusion once every 3 weeks<br>* Other names: BGB-A317;|
| Experimental: Salvage chemotherapy<br>Salvage chemotherapy for up to 45 months | Drug: Salvage Chemotherapy<br>* Salvage chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP (dexamethasone, cisplatin, high-dose cytarabine), ESHAP (etoposide, methylprednisolone, high-dose cytarabine and cisplatin), DICE (dexamethasone, ifosfamide, carboplatin, etoposide), ICE (ifosfamide, carboplatin, etoposide), IGEV (ifosfamide, gemcitabine, vinorelbine, prednisone), GVD (gemcitabine, vinorelbine, liposomal doxorubicin), and MINE (etoposide, ifosfamide, mesna, mitoxantrone)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) by Investigator | Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first | Up to 45 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response (DOR) by Investigator | The time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first | Up to 45 months | 
| Overall Response Rate (ORR) by Investigator | The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR) | Up to 45 months | 
| Rate of Complete Response (CR) by Investigator | The proportion of participants who achieves a best overall response of CR | Up to 45 months | 
| Time to Response (TTR) by Investigator | Time from the date of randomization to the time the response criteria are first met | Up to 45 months | 
| Overall survival (OS) | Defined as the time from the date of randomization to the date of death due to any reason | Up to 45 months | 
| Number of participants experiencing Adverse Events (AEs) |  | Up to 45 months | 
| Number of participants experiencing Serious Adverse Events (SAEs) |  | Up to 45 months |