Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the efficacy of tislelizumab in participants with relapsed/refractory classical Hodgkin lymphoma, as measured by the overall response rate per the Lugano Classification, and as determined by the investigator.

Official Title
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A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Conditions
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Classical Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Tislelizumab


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Histologically confirmed diagnosis of relapsed or refractory cHL Relapsed cHL (disease progression after PR or CR to the most recent therapy) or refractory cHL (failure to achieve PR or CR to most recent therapy). Participants will be allocated to one of two cohorts based on the following criteria: Cohort 1: Relapsed or refractory to prior autologous hematopoietic stem cell transplant (HSCT) Has failed to achieve a response or progressed after autologous HSCT Is not a candidate for additional autologous or allogeneic HSCT Cohort 2: Relapsed or refractory to salvage chemotherapy, and has not received prior autologous or allogeneic HSCT Is not a candidate for autologous or allogeneic HSCT Has received at least 1 prior systemic regimen for cHL Measurable disease defined as ≥ 1 2-[18F] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion that is > 1.5 cm in the longest diameter, or ≥ 1 FDG-avid extra-nodal lesion (eg, hepatic nodules) that is > 1 cm in the longest diameter Eastern Cancer Oncology Group (ECOG) performance status of 0 or 1 Key Exclusion Criteria: Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma Prior allogeneic hematopoietic stem cell transplantation Prior therapy targeting PD-1 , PD-L1,PD-L2, or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) pathways Active autoimmune disease or history of autoimmune disease that may relapse 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Participants with relapsed or refractory Classical Hodgkin Lymphoma (cHL) who have failed to achieve a response or progressed after autologous hematopoietic stem cell transplantation (HSCT) | Drug: Tislelizumab<br>* 200 mg intravenously (IV) every 3 weeks (Q3W)<br>* Other names: BGB-A317;|
| Experimental: Cohort 2<br>Participants with relapsed or refractory cHL who have received at least 1 prior systemic regimen and are not candidates for autologous or allogeneic HSCT | Drug: Tislelizumab<br>* 200 mg intravenously (IV) every 3 weeks (Q3W)<br>* Other names: BGB-A317;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR) | Up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response Rate (CRR) | Defined as the proportion of participants who achieve the best response of complete response (CR) | Up to 30 months | 
| Duration of Response (DOR) | Time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first. Only participants who have achieved an overall response will be included in the analysis. | Up to 30 months | 
| Time to Response (TTR) | Time from the date of the first dose of tislelizumab to the time the response criteria are first met. Only participants who have achieved an overall response will be included in the analysis. | Up to 30 months | 
| Number of participants Experiencing Adverse Events (AEs) |  | Up to 30 days posttreatment (Treatment duration is 30 months) | 
| Number of participants Experiencing Serious Adverse Events (SAEs) |  | Up to 30 days posttreatment (Treatment duration is 30 months) |