Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

NCT04318080 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: BGB-A317-2102019-002105-22
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 4

Brief Summary

This was a Phase 2 trial evaluating the effectiveness and safety of tislelizumab in participants with relapsed or hard-to-treat classical Hodgkin lymphoma (cHL). Participants were grouped by prior treatments. The main outcome was to assess overall response rate (ORR) across both cohorts. Participants continued receiving the study treatment until their disease got worse, side effects became too severe, or they chose to stop for other reasons.

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) by Positron Emission Tomography (PET) and Computed Tomography (CT) per the Lugano Classification and as determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT, with no new lesions detected. PR was defined as a significant reduction in metabolic activity or lesion size consistent with partial tumor shrinkage as per Lugano criteria.

  From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.

Secondary Outcomes (4)

• Complete Response Rate (CRR)

  From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.

• Duration of Response (DOR)

  From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.

• Time to Response (TTR)

  From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.

• Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  From the date of the first dose of tislelizumab through 90 days after the last dose (maximum duration of tislelizumab exposure was 168 weeks)

Study Arms (2)

Cohort 1

EXPERIMENTAL

Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.

Drug: Tislelizumab

Cohort 2

EXPERIMENTAL

Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

200 milligrams (mg) intravenously every 3 weeks (Q3W)

Also known as: BGB-A317

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants had a histologically confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma (cHL).
• Participants had either:
• Relapsed cHL, defined as disease progression after a partial response (PR) or complete response (CR) to their most recent therapy; or
• Refractory cHL, defined as failure to achieve PR or CR to their most recent therapy.
• Participants were assigned to one of two cohorts based on the following:
• Cohort 1: Participants who were relapsed or refractory after prior autologous hematopoietic stem cell transplantation (HSCT):
• Had failed to achieve a response or had experienced disease progression following autologous HSCT (a transplant using the participant's own stem cells).
• Were not considered candidates for additional autologous or allogeneic HSCT (a transplant using donor stem cells).
• Cohort 2: Participants who were relapsed or refractory to salvage chemotherapy and had not received prior HSCT:
• Were not considered candidates for autologous or allogeneic HSCT.
• Had received at least one prior systemic therapy regimen for cHL.
• Participants had measurable disease, defined as at least one positron emission tomography (PET)-positive, 2-\\\[18F\] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion greater than 1.5 centimeters (cm) in longest diameter, or at least one FDG-avid extranodal lesion (hepatic nodule) greater than 1.0 cm in longest diameter.
• Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, indicating full activity or restricted activity but capable of self-care.

You may not qualify if:

• Participants had nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma.
• Participants had received prior allogeneic HSCT.
• Participants had received prior therapy targeting immune checkpoint pathways, including programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), programmed death-ligand 2 (PD-L2), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
• Participants had active autoimmune disease or a history of autoimmune disease with potential to relapse.

Sponsors & Collaborators

• BeiGene: lead
• Lymphoma Study Association: collaborator

Study Sites (4)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-2013, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920-1511, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112-5550, United States

Location

Monash Health

Clayton, Victoria, VIC 3168, Australia

Location

Related Publications (3)

• Ghesquières H, López-Guillermo A, De la Cruz F, et al. Tislelizumab, an anti-PD-1 antibody, in patients with relapsed/refractory classical Hodgkin lymphoma in TIRHOL BGB-A317-210: a prospective multicenter LYSA phase 2 study conducted in Western countries. Blood. 2023;142(Suppl 1):1717. DOI:10.1182/blood-2023-188545

  RESULT

• Ghesquières H, et al. TIRHOL (BGB-A317-210): International Phase 2 Study in Relapsed/Refractory Classical Hodgkin Lymphoma. Presented at: Congrès de la Société Française d'Hématologie (SFH); March 2024; Paris, France.

  RESULT

• Ghesquières H, López-Guillermo A, De la Cruz F, et al. Final analysis from the LYSA phase 2 TIRHOL study (BGB-A317-210): tislelizumab in relapsed/refractory classical Hodgkin lymphoma. Presented at: 18th International Conference on Malignant Lymphoma (ICML); June 18-22, 2025; Lugano, Switzerland. https://doi.org/10.1002/hon.70093_130

  RESULT

MeSH Terms

Interventions

tislelizumab

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

1 877-828-5568

Study Officials

• Herve Ghesguieres

  Lymphoma Study Association

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 23, 2020
• Study Start: August 20, 2020
• Primary Completion: December 12, 2022
• Study Completion: August 29, 2024
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (3); AU (1)