Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (TIRHOL)

A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Classical Hodgkin Lymphoma
• Intervention / Treatment: Drug: Tislelizumab

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Border Medical Oncology
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Center
    • Fitzroy, Victoria, Australia, 3065
      • Saint Vincent's Hospital Melbourne
• Belgium
  • Bruxelles, Belgium, 1000
    • Institut Jules Bordet
  • Liège, Belgium, 4000
    • CHU de Liège - Domaine Universitaire du Sart Tilman
  • Yvoir, Belgium, 5530
    • CHU UCL Namur - site Godinne
• France
  • Caen, France, 14033
    • Institut d'Hematologie de Basse-Normandie
  • Créteil, France, 94010
    • Hopital Henri-Mondor
  • Dijon, France, 21000
    • Chu Dijon Bourgogne
  • La Roche-sur-Yon, France, 85925
    • CHD de Vendée
  • Le Chesnay, France, 78157
    • CH de Versailles - Hôpital André Mignot
  • Lille, France, 59307
    • CHRU de Lille- Hôpital Claude Huriez
  • Limoges, France, 87042
    • CHU de Limoges - Hôpital Dupuytren
  • Montpellier, France, 34090
    • CHU de Montpellier
  • Nantes, France, 44093
    • CHU de Nantes
  • Paris, France, 75475
    • Hôpital Saint-Louis
  • Pessac, France, 33604
    • CHU de Bordeaux Hôpital Haut-Lévêque
  • Pierre-Bénite, France, 69495
    • CHU Lyon-Sud
  • Rouen, France, 76038
    • Centre Henri-Becquerel
  • Strasbourg, France, 67098
    • CHRU de Strasbourg
  • Toulouse, France, 31059
    • IUCT Oncopole
  • Vandœuvre-lès-Nancy, France, 54511
    • CHU Brabois
  • Val De Marne
    • Villejuif, Val De Marne, France, 94805
      • Institut Gustave Roussy- Cancer Campus Grand Paris
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Hospital Oncologico-PR Med Ctr
• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Cancer Center
    • Bergen, New Jersey, United States, 07645
      • Memorial Sloan Kettering Cancer Center
    • Monmouth Junction, New Jersey, United States, 07748
      • Memorial Sloan Kettering Cancer Center
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center
    • Nassau, New York, United States, 11553
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Westchester, New York, United States, 10604
      • Memorial Sloan Kettering Cancer Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of TN Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Center, University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

   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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 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)	Drug: Tislelizumab; 200 mg intravenously (IV) every 3 weeks (Q3W); Other Names: BGB-A317
Experimental: Cohort 2; Participants with relapsed or refractory cHL who have received at least 1 prior systemic regimen and are not candidates for autologous or allogeneic HSCT	Drug: Tislelizumab; 200 mg intravenously (IV) every 3 weeks (Q3W); Other Names: BGB-A317

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BeiGene
• Collaborators: Lymphoma Study Association
• Investigators: Principal Investigator: Herve Ghesguieres, Lymphoma Study Association

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Actual): December 12, 2022
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Antineoplastic Agents; Antineoplastic Agents, Immunological; Tislelizumab
• Other Study ID Numbers: BGB-A317-210; 2019-002105-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No