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Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma

Primary Purpose

Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tislelizumab
BGB-A425
LBL-007
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants with histologically or cytologically confirmed R/M HNSCC that is considered incurable by local therapies The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx Participants should not have had prior systemic therapy administered in the R/M setting; systemic therapy which was completed prior to randomization/enrollment if given as part of multimodal treatment for locally or locoregionally advanced disease is allowed Participants must have positive PD-L1 expression (Combined Positive Score [CPS] ≥ 1) Have at least 1 measurable lesion as defined per RECIST v1.1 Eastern Cooperative Oncology Group Performance Status of 0 or 1 Adequate hematologic and organ function as indicated by specific laboratory values within 7 days of first dose of study drug Willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s) Exclusion Criteria: Recurrent or metastatic carcinoma of the nasopharynx (any histology), squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland primary tumor or non-squamous histologies (eg, mucosal melanoma) Prior therapy with an anti-PD-1, anti-PD-L1, PD-L2, T-cell immunoglobulin and mucin domain containing-3 (TIM-3), LAG-3, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways Any active malignancy ≤ 2 years before randomization/enrollment except for the specific cancer under investigation in this study, those with a negligible risk of metastasis or death, and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, and carcinoma in situ of the cervix or breast) History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, and acute lung diseases A history of severe hypersensitivity reactions to other monoclonal antibodies or has experienced a severe immune-mediated adverse event (imAE), an imAE that led to treatment discontinuation, or a cardiac or ocular imAE of any grade with prior immunotherapy Note: Other inclusion and exclusion criteria may apply

Sites / Locations

  • Valkyrie Clinical TrialsRecruiting
  • Cancer Care NorthwestRecruiting
  • North Shore Private HospitalRecruiting
  • Gold Coast Private HospitalRecruiting
  • Greenslopes Private HospitalRecruiting
  • Cancer Research South AustraliaRecruiting
  • Northeast Health WangarattaRecruiting
  • St John of God, MurdochRecruiting
  • Beijing Cancer HospitalRecruiting
  • Fujian Cancer HospitalRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • The First Affiliated Hospital of Nanchang University Branch DonghuRecruiting
  • Shandong Cancer HospitalRecruiting
  • Shanghai East HospitalRecruiting
  • Sichuan Cancer Hospital and InstituteRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Tislelizumab

Tislelizumab + BGB-A425

Tislelizumab + LBL-007

Tislelizumab + BGB-A425 + LBL-007

Arm Description

Tislelizumab 200 milligrams (mg) administered once every 3 weeks

Tislelizumab 200 mg administered once every 3 weeks with BGB-A425

Tislelizumab 200 mg administered once every 3 weeks with LBL-007

Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
ORR is defined as percentage of participants who have a confirmed complete response (CR) or a confirmed partial response (PR) as assessed by the investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures

Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease assessed by the investigators per RECIST v1.1 or death, whichever occurs first
Duration of Response (DOR)
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or a durable stable disease (SD) (SD duration ≥ 24 weeks)
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or SD
Number of Participants with Adverse Events
Number of participants with adverse events, including laboratory values, vital signs, physical examinations, and electrocardiogram findings
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause
Number of Participants with Anti-Drug Antibodies (ADAs)
Number of participants with detectable ADAs

Full Information

First Posted
June 9, 2023
Last Updated
October 18, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT05909904
Brief Title
Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
Official Title
A Randomized, Phase 2, Open-Label, Multi-Arm Study of Tislelizumab in Combination With Investigational Agents as First-Line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed to evaluate the efficacy and safety of tislelizumab and tislelizumab in combination with investigational agent(s) in first-line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Detailed Description
This study will test whether tislelizumab alone and combined with other investigational agents can be used to improve treatment outcomes in participants with head and neck squamous cell carcinoma. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment and to determine what adverse events, or side effects, participants might experience. Tislelizumab is used to block the programmed cell death protein-1 pathway so that immune system cells (T-cells) can better protect the body from infection and find tumor cells to attack. Tislelizumab may be used in combination with other therapies as a promising approach with potential therapeutic benefits to treat participants with cancer. The study will enroll approximately 160 participants. Participants will be randomly assigned (by chance, similar to flipping a coin) to one of the various treatment groups. Tislelizumab and investigational agents will be administered as an infusion through a vein at regularly scheduled intervals. The study will take place at multiple centers worldwide. Treatments will continue until participants experience no benefits, too many side effects, or withdraw consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab
Arm Type
Active Comparator
Arm Description
Tislelizumab 200 milligrams (mg) administered once every 3 weeks
Arm Title
Tislelizumab + BGB-A425
Arm Type
Experimental
Arm Description
Tislelizumab 200 mg administered once every 3 weeks with BGB-A425
Arm Title
Tislelizumab + LBL-007
Arm Type
Experimental
Arm Description
Tislelizumab 200 mg administered once every 3 weeks with LBL-007
Arm Title
Tislelizumab + BGB-A425 + LBL-007
Arm Type
Experimental
Arm Description
Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
BGB-A425
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
LBL-007
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as percentage of participants who have a confirmed complete response (CR) or a confirmed partial response (PR) as assessed by the investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame
Up to approximately 3 years and 6 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease assessed by the investigators per RECIST v1.1 or death, whichever occurs first
Time Frame
Up to approximately 3 years and 6 months
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first
Time Frame
Up to approximately 3 years and 6 months
Title
Clinical Benefit Rate (CBR)
Description
CBR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or a durable stable disease (SD) (SD duration ≥ 24 weeks)
Time Frame
Up to approximately 3 years and 6 months
Title
Disease Control Rate (DCR)
Description
DCR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or SD
Time Frame
Up to approximately 3 years and 6 months
Title
Number of Participants with Adverse Events
Description
Number of participants with adverse events, including laboratory values, vital signs, physical examinations, and electrocardiogram findings
Time Frame
Up to approximately 3 years and 6 months
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death due to any cause
Time Frame
Up to approximately 3 years and 6 months
Title
Number of Participants with Anti-Drug Antibodies (ADAs)
Description
Number of participants with detectable ADAs
Time Frame
Up to approximately 3 years and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with histologically or cytologically confirmed R/M HNSCC that is considered incurable by local therapies The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx Participants should not have had prior systemic therapy administered in the R/M setting; systemic therapy which was completed prior to randomization/enrollment if given as part of multimodal treatment for locally or locoregionally advanced disease is allowed Participants must have positive PD-L1 expression (Combined Positive Score [CPS] ≥ 1) Have at least 1 measurable lesion as defined per RECIST v1.1 Eastern Cooperative Oncology Group Performance Status of 0 or 1 Adequate hematologic and organ function as indicated by specific laboratory values within 7 days of first dose of study drug Willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s) Exclusion Criteria: Recurrent or metastatic carcinoma of the nasopharynx (any histology), squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland primary tumor or non-squamous histologies (eg, mucosal melanoma) Prior therapy with an anti-PD-1, anti-PD-L1, PD-L2, T-cell immunoglobulin and mucin domain containing-3 (TIM-3), LAG-3, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways Any active malignancy ≤ 2 years before randomization/enrollment except for the specific cancer under investigation in this study, those with a negligible risk of metastasis or death, and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, and carcinoma in situ of the cervix or breast) History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, and acute lung diseases A history of severe hypersensitivity reactions to other monoclonal antibodies or has experienced a severe immune-mediated adverse event (imAE), an imAE that led to treatment discontinuation, or a cardiac or ocular imAE of any grade with prior immunotherapy Note: Other inclusion and exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
1-877-828-5568
Email
clinicaltrials@beigene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
Valkyrie Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Care Northwest
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Recruiting
Facility Name
North Shore Private Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gold Coast Private Hospital
City
Gold Coast
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cancer Research South Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Northeast Health Wangaratta
City
Wangaratta
State/Province
Victoria
ZIP/Postal Code
3677
Country
Australia
Individual Site Status
Recruiting
Facility Name
St John of God, Murdoch
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University Branch Donghu
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Cancer Hospital and Institute
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Hospital
City
Dalseogu
State/Province
Daegu Gwang'yeogsi
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma

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