A Study of Tislelizumab as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma

NCT03209973 | Completed Phase 2 Results

• 2 other identifiers: BGB-A317-203CTR20170119
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 12

Brief Summary

The primary objective of this study was to evaluate the efficacy of tislelizumab assessed by Independent Review Committee (IRC) in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Overall Response Rate (ORR) per the Lugano Classification

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is defined as the proportion of participants who achieve a best response of Complete Response (CR) or Partial Response (PR), as assessed by Independent Review committee (IRC) per the Lugano Classification

  From the date of first dose Up to approximately 3 year and 7 months

Secondary Outcomes (7)

• Progression-free Survival (PFS)

  From the date of first dose until end of study (Up to approximately 3 years and 7 months)

• Duration of Response (DOR)

  From the date of first dose until end of study (Up to approximately 3 years and 7 months)

• Rate of Complete Response (CRR)

  From the date of first dose until end of study (Up to approximately 3 years and 7 months)

• Time to Response (TTR)

  From the date of first dose until end of study (Up to approximately 3 years and 7 months)

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

  From the date of first dose until end of study (Up to approximately 3 years and 7 months)

Study Arms (1)

Tislelizumab

EXPERIMENTAL

Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

Administered as specified in the treatment arm

Also known as: BGB-A317

Tislelizumab

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed relapsed or refractory cHL (biopsy from diagnosis or at any relapse is acceptable).
• Participants must have relapsed (disease progression after most recent therapy) or refractory (failure to achieve complete Response (CR) /complete metabolic response \[CMR\] or partial response (PR) to most recent therapy) cHL and and failed to achieve a response or progressed after auto-SCT or meet the criteria of ineligible for auto-SCT.
• Participants must have measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in the longest diameter, or ≥ 1 extra-nodal lesion (e.g. hepatic nodules) that is \> 1 cm in the longest diameter.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks.
• participants must have adequate organ functions as indicated by the following laboratory values:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, independent of growth factor support within 7 days of first dose.
• Platelet ≥ 75 x 109/L, independent of growth factor support or transfusion within 7 days of first dose.
• Hemoglobin (Hgb) ≥ 8 g/dL or ≥ 5 mmol/L.
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN).
• Aspartate aminotransferase (AST)/glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/glutamic-pyruvic transaminase (SGPT) ≤ 2.5 x upper limit of normal (ULN), or ≤ 5X ULN if liver metastases are present.
• Serum total bilirubin ≤ 1.5 x ULN (total bilirubin level \< 4 x ULN for participants with Gilbert's syndrome).
• International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy and coagulation parameters (prothrombin time \[PT/INR\] and aPTT) are within intended therapeutic range of intended use of the anticoagulant at time of Screening. Participants with factor inhibitors prolonging PT or INR may be included after discussion with the medical monitor.
• Participants must have no evidence of dyspnea at rest and a pulse oximetry of \> 92% while breathing room air.
• Participants must have forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) \> 60% by pulmonary function test (PFT); carbon monoxide diffusion capacity (DLCO), FEV1 and FVC all \> 50 % predicted value; all PFTs must be obtained within 4 weeks prior to the first dose of tislelizumab.

You may not qualify if:

• Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma.
• Prior allogeneic hematopoietic stem cell transplant.
• History of severe hypersensitivity reaction to monoclonal antibodies.
• New York Heart Association (NYHA) class III or IV heart failure, unstable angina, severe uncontrolled ventricular arrhythmia, electrocardiographic evidence of acute ischemia, or myocardial infarction within 6 months of first day of Screening.
• 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.
• Prior therapy targeting PD-1 or PD-L1.
• Participants with active autoimmune disease or history of autoimmune disease with high risk of recurrence including but not limited to history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barrè syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome.
• Note: Participants is permitted to enroll if he/she has vitiligo, eczema, type I diabetes mellitus, endocrine deficiencies including thyroiditis managed with replacement hormone and/or physiologic corticosteroid. Participants with rheumatoid arthritis and/or other arthropathies, Sjögren's syndrome or psoriasis controlled with topical medication, and participants with positive serology such as positive antinuclear antibody (ANA) or anti-thyroid antibody should be evaluated for presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
• Conditions requiring systemic treatment with either corticosteroids (\> 10 mg daily Prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of tislelizumab.
• Note: Adrenal replacement doses of ≤ 10 mg daily Prednisone are permitted in the absence of active autoimmune disease. Topical, ocular, intra-articular, intra-nasal and inhalational corticosteroid (with minimal systemic absorption), a brief course of corticosteroid for prophylaxis (e.g. contrast dye allergy) or for treatment of non-autoimmune conditions (e.g. delayed-type hypersensitivity reaction caused by contact allergen) are allowed.
• Has history of interstitial lung disease or non-infectious pneumonitis or has evidence of interstitial lung disease or non infectious pneumonitis currently.
• QT Interval Corrected by the Fridericia Correction Formula (QTcF)interval \> 480 msec, unless secondary to bundle branch block.
• Serious acute or chronic infection requiring systemic therapy.
• Known central nervous system (CNS) lymphoma.
• Underlying medical conditions that, in the Investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (12)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Chinese Pla General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality, 300020, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (3)

• Song Y, Gao Q, Zhang H, Fan L, Zhou J, Zou D, Li W, Yang H, Liu T, Wang Q, Lv F, Guo H, Yang L, Elstrom R, Huang J, Novotny W, Wei V, Zhu J. Treatment of relapsed or refractory classical Hodgkin lymphoma with the anti-PD-1, tislelizumab: results of a phase 2, single-arm, multicenter study. Leukemia. 2020 Feb;34(2):533-542. doi: 10.1038/s41375-019-0545-2. Epub 2019 Sep 13.

  PMID: 31520078 RESULT

• Song Y, Gao Q, Zhang H, Fan L, Zhou J, Zou D, Li W, Yang H, Liu T, Wang Q, Lv F, Guo H, Zhao X, Wang D, Zhang P, Wang Y, Wang L, Liu T, Zhang Y, Shen Z, Huang J, Zhu J. Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis. Clin Cancer Res. 2022 Mar 15;28(6):1147-1156. doi: 10.1158/1078-0432.CCR-21-2023.

  PMID: 34716199 DERIVED

• Chen J, Zhang H, Zhu L, Zhao Y, Ding Y, Yuan Y. Tislelizumab for the treatment of classical Hodgkin's lymphoma. Drugs Today (Barc). 2020 Dec;56(12):781-785. doi: 10.1358/dot.2020.56.12.3233362.

  PMID: 33332484 DERIVED

MeSH Terms

Interventions

tislelizumab

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• Study Director

  BeiGene

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: July 6, 2017
• Study Start: April 21, 2017
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: February 5, 2025
• Results First Posted: October 12, 2020

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (12)