Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Collaborator: Lymphoma Study Association

Criteria

Key Inclusion Criteria:

1. Histologically confirmed diagnosis of relapsed or refractory cHL

2. 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) and brentuximab vedotin

1. Has failed to achieve a response or progressed after autologous HSCT and failed to achieve a response or progressed after brentuximab vedotin

2. Is not a candidate for additional autologous or allogeneic HSCT

Cohort 2: Relapsed or refractory to salvage chemotherapy, including brentuximab vedotin, and has not received prior autologous or allogeneic HSCT

1. Is not a candidate for autologous or allogeneic HSCT due to disease refractory to salvage chemotherapy

2. Has received at least 2 prior systemic chemotherapy regimens for cHL and failed to achieve a response or progressed after brentuximab vedotin

3. 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

4. Eastern Cancer Oncology Group (ECOG) performance status of 0 or 1

Key Exclusion Criteria:

1. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma

2. Prior allogeneic hematopoietic stem cell transplantation

3. Prior therapy targeting PD-1 , PD-L1,PD-L2, or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) pathways

4. Active autoimmune disease or history of autoimmune disease that may relapse

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.