Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
About the study
Who can take part
INCLUSION CRITERIA
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
EXCLUSION CRITERIA
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.
Study Locations
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How to Apply
Study’s details
Contition
Classical Hodgkin Lymphoma
Age (in years)
18+
Phase
Phase 2
Participants needed
46
Est. Completion Date
Sep 30, 2024
Treatment type
Interventional
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT04318080
Study number
BGB-A317-210
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