Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma

A Multicenter, Open-Label, Randomized Controlled Phase 3 Study of Tislelizumab Monotherapy Versus Salvage Chemotherapy in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

The primary objective of this study is to evaluate the efficacy of tislelizumab in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Progression-free Survival (PFS) as assessed by investigator

Study Overview

• Status: Recruiting
• Conditions: Classical Hodgkin Lymphoma
• Intervention / Treatment: Drug: Tislelizumab; Drug: Salvage Chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 123
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: BeiGene; Phone Number: 1-877-828-5568; Email: clinicaltrials@beigene.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
  • Fujian
    • Quanzhou, Fujian, China, 362000
      • Recruiting
      • Quanzhou First Affliated Hospital of Fujian Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Harbin medical university cancer hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • Jilin cancer hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital

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 cHL.Must have relapsed or refractory ( cHL and

1. Has failed to achieve a response or progressed after autologous hematopoietic stem cell transplant (ASCT). or

2. Has received at least two prior lines of systemic chemotherapies for cHL and is not an ASCT candidate.

   2. Must have measurable disease 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

   4. Must have adequate organ functions. 5. Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy used to control cancer including locoregional treatment must have been completed ≥ 4 weeks before the first dose of study drug, and all treatment-related adverse events are stable and have either returned to baseline or Grade 0/1

   Key Exclusion Criteria:

   1. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma. Known central nervous system (CNS) lymphoma.
   2. Prior allogeneic hematopoietic stem cell transplant. ASCT or Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) within 100 days of first dose of study drug.
   3. Prior therapies targeting PD-1 or PD-L1.
   4. Prior malignancy within the past 3 years except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast.
   5. Participant with active autoimmune disease or history of autoimmune disease with high risk of recurrence.
   6. Serious acute or chronic infection requiring systemic therapy.
   7. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

   NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab; Tislelizumab monotherapy for up to 45 months	Drug: Tislelizumab; 200 mg administered via intravenous (IV) infusion once every 3 weeks; Other Names: BGB-A317
Experimental: Salvage chemotherapy; Salvage chemotherapy for up to 45 months	Drug: Salvage Chemotherapy; Salvage chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP (dexamethasone, cisplatin, high-dose cytarabine), ESHAP (etoposide, methylprednisolone, high-dose cytarabine and cisplatin), DICE (dexamethasone, ifosfamide, carboplatin, etoposide), ICE (ifosfamide, carboplatin, etoposide), IGEV (ifosfamide, gemcitabine, vinorelbine, prednisone), GVD (gemcitabine, vinorelbine, liposomal doxorubicin), and MINE (etoposide, ifosfamide, mesna, mitoxantrone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) by Investigator	Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first	Up to 45 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR) by Investigator	The time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first	Up to 45 months
Overall Response Rate (ORR) by Investigator	The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR)	Up to 45 months
Rate of Complete Response (CR) by Investigator	The proportion of participants who achieves a best overall response of CR	Up to 45 months
Time to Response (TTR) by Investigator	Time from the date of randomization to the time the response criteria are first met	Up to 45 months
Overall survival (OS)	Defined as the time from the date of randomization to the date of death due to any reason	Up to 45 months
Number of participants experiencing Adverse Events (AEs)		Up to 45 months
Number of participants experiencing Serious Adverse Events (SAEs)		Up to 45 months

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Xia Zhao, MD, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): September 26, 2024
• Study Completion (Estimated): March 26, 2025

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 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-A317-314; CTR20201517 (Registry Identifier: CDE)

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No