Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

Phase 2

Completed

• Conditions: Classical Hodgkin Lymphoma
• Interventions: Drug: Tislelizumab

• Registration Number: NCT04318080
• Lead Sponsor: BeiGene

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Study Start: 2020-08-20
• Primary Completion: 2022-12-12
• Disposition First Submitted: 2023-12-12
• Disposition First Posted: 2023-12-14
• Study Completion: 2024-08-30
• Status Verified: 2024-11
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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)

   1. Has failed to achieve a response or progressed after autologous HSCT
   2. 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

   1. Is not a candidate for autologous or allogeneic HSCT
   2. Has received at least 1 prior systemic regimen for cHL

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Tislelizumab	Participants with relapsed or refractory cHL who have received at least 1 prior systemic regimen and are not candidates for autologous or allogeneic HSCT
Cohort 1	Tislelizumab	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)

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Up to 30 months	ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)

Secondary Outcome Measures

Name	Time	Method
Complete Response Rate (CRR)	Up to 30 months	Defined as the proportion of participants who achieve the best response of complete response (CR)
Duration of Response (DOR)	Up to 30 months	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.
Time to Response (TTR)	Up to 30 months	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.
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)

Trial Locations

Locations (4)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

Monash Health; 🇦🇺 Clayton, Victoria, Australia