Description:
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.
Title
- Brief Title: Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
- Official Title: A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
BGB-A317-210
- SECONDARY ID:
2019-002105-22
- NCT ID:
NCT04318080
Conditions
- Classical Hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Tislelizumab | BGB-A317 | Cohort 1 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort 1 | Experimental | 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) and failed to achieve a response or progressed after brentuximab vedotin | |
Cohort 2 | Experimental | Participants with relapsed or refractory cHL who have received at least 2 prior systemic chemotherapy regimens and failed to achieve a response or progressed after brentuximab vedotin, and are not candidates for autologous or allogeneic HSCT | |
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Response Rate (ORR) |
Time Frame: | Up to 30 months |
Safety Issue: | |
Description: | ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR) |
Secondary Outcome Measures
Measure: | Complete Response Rate (CRR) |
Time Frame: | Up to 30 months |
Safety Issue: | |
Description: | Defined as the proportion of patients who achieve the best response of complete response (CR) |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 30 months |
Safety Issue: | |
Description: | Time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first |
Measure: | Time to Response (TTR) |
Time Frame: | Up to 30 months |
Safety Issue: | |
Description: | Time from the date of the first dose of tislelizumab to the time the response criteria are first met |
Measure: | Number of participants Experiencing Adverse Events (AEs) |
Time Frame: | Up to 30 days posttreatment (Treatment duration is 30 months) |
Safety Issue: | |
Description: | |
Measure: | Number of participants Experiencing Serious Adverse Events (SAEs) |
Time Frame: | Up to 30 days posttreatment (Treatment duration is 30 months) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | BeiGene |
Last Updated
June 21, 2021